A Guide To Clinical Trial Recruitment

Home / Resources / A Guide to Clinical Trial Recruitment

Match to Clinical Trial Recruitment

Clinical trial patient recruitment is crucial to success. However, organizations often wait too long to plan a clinical trial recruitment strategy. While clinical trial advertising is easier than ever online, ads represent just one plank in a complete clinical trial marketing strategy.

Since there are so many types of clinical studies, administrators can’t rely on patient enthusiasm to reach their recruitment goals. Budgets are often tight, too, limiting the amount of direct compensation available.

Luckily, there are lessons in clinical trial recruitment that apply to virtually all studies.

Proven Methods for In-House Clinical Trial Patient Recruitment

Done right, many low-cost clinical trial marketing techniques have high ROI. They work hand in hand with paid media buys and other clinical trial advertising in the digital age. A multi-pronged strategy adopted early is more likely to prove effective than sticking with a single technique.

Let’s review some of the best patient recruitment tactics:

Share Trial Information with Local Healthcare Providers

Of all potential sources for information on clinical trials, patients surveyed named their doctor’s office as #1 by a wide margin: 73%. On the other hand, clinical trial advertising can fall flat on TV, print, radio, and even online (21% showed interest) and when associated with a drug company (22% showed interest).

Reach Out to Nonprofits and Patient Advocates

Patients involved in the community surrounding their condition are more likely to understand the value of clinical trials. Connecting with nonprofits that affect them is a great way to ensure they will be informed about the opportunities you offer. Such partnerships are often free.

Tailor Digital Outreach to Your Patients

Banners aren’t the only form of clinical trial advertising that works online. You can connect with patients and build rapport by promoting your trial on social media. Twitter allows you to engage in conversation with prospective participants, while Facebook enables targeted, personalized ads.

Target Patients Who Meet Inclusion Criteria

Reaching out to patients who don’t fit your criteria costs you in time and money. Consider working with mid-market partners, like testing laboratories and EHR companies, whose data permits them to identify patients that meet your criteria.

Need Superior Results? Consider a Clinical Trial Patient Recruitment Company

Clinical trial patient recruitment companies connect with patients, qualify them, and convert those who meet requirements. Most such firms have well-established ties to healthcare providers and the community.

A good clinical trial recruitment company can accelerate your efforts by leveraging its own network of nonprofit partnerships. Some offer boutique services such as lab-verified referrals and targeted outreach.

Before choosing a company, ask these key questions:

  • Do you need advice on choosing the site for your trial?
  • Do you need help at the start of your trial or “rescue” support?
  • What kind of budget do you have available?
  • Has the company worked with your therapeutic area?
  • How does the company find patients to participate?
  • How will patients be screened?

The best recruitment partner will have a proven record of results for trials in your therapeutic area and phase. The company should also have a strong network that facilitates connection with local patients and a clear process for screening them.

Common Clinical Trial Recruitment Problems and Solutions

Clinical trial patient recruitment can sometimes feel like finding a needle in a haystack. If you run into what feels like an insurmountable problem, its essential to know how to pivot your clinical trial marketing:

Ineligible Patient Referrals

If you spend too much time with ineligible patients, diversify your outreach portfolio. Factors outside your control, like poor data hygiene or competition for patients, can cut into results. Lab and provider partnerships can prequalify more applicants. This also makes research sites perform better.

Patients Situated Too Far from Sites

First, check the targeting of your current clinical trial advertising to see if you can narrow the geography to a smaller radius around your sites. Consider travel services or rideshare partnerships to help patients make their appointments, especially in cases where symptoms interfere with travel ability.

Patients Become Unresponsive

If your recruitment pipeline is leaking before patients reach your sites, there’s likely a follow-up or data accuracy problem. Double-check that your emails and phone messages are getting through. Consider integrating text messaging into your campaign: It can be automated and has a high response rate.

Outreach Isn’t “Connecting”

If outreach simply isn’t working, it’s crucial to walk through your messaging, step by step, at each patient touchpoint. Although many patients are motivated by altruism, you may need to address barriers to entry (in terms of convenience or travel) or reassess your compensation strategy.

Clinical trial marketing takes work, but the results are worth it. By developing a strategy and following through, you help to ensure the efforts of your researchers and patients can move the needle on the future of care.

  • https://www.antidote.me/blog/10-clinical-trial-recruitment-strategies-that-work
  • https://www.antidote.me/blog/15-clinical-trial-patient-recruitment-companies

Other Resources

  • Guide to Clinical Trials for Alcohol
  • Guide to Clinical Trials for Asbestos
  • Clinical Trial Guide for Seniors and the Elderly
  • Guide to Clinical Trials for Minorities
  • Clinical Trial Guide for Parents and Children
  • Guide to Clinical Trials for Pets
  • Guide To Keeping Your Health Records Secure
  • Clinical Trials on the Effects of Vaping
  • Clinical Trials on the Effects of Bullying
  • Clinical Trials on the Positive Effects of Gardening and Experiencing Nature
  • Clinical Trials on the Disaster Mental Health
  • A Guide to Sleep and Clinical Trials
  • A Guide to Clinical Trial Recruitment
  • What is Clinical Research?
  • Research Studies for Money

Customize Your Path

Filters Applied

Customize Your Experience.

Utilize the "Customize Your Path" feature to refine the information displayed in myRESEARCHpath based on your role, project inclusions, sponsor or funding, and management center.

Participant and patient engagement, recruitment, and retention

Need assistance with participant engagement, recruitment, or retention?

Get help with participant engagement, recruitment, or retention.

Contact the Recruitment Innovation Center (RIC):

  • Submit a help request

Successful participant engagement, recruitment, and retention in research studies  can be one of the most challenging aspects of conducting research. Effective and efficient engagement, recruitment, and retention strategies are critical to successfully achieving enrollment targets while also prioritizing participant safety, well-being and trust.

This page provides resources, best practices and tools for developing and implementing robust engagement, recruitment, and retention strategies. However, it’s important to note that there is no one-size-fits-all approach to good planning. In fact, effective engagement, recruitment and retention planning should:

  • Be proactive
  • Start upstream at study design
  • Anticipate and account for downstream barriers
  • Be data-driven and evidence-based
  • Be thoughtful and realistic
  • Include input from all relevant stakeholders
  • Be participant-centered
  • Be resourced appropriately
  • Be adjusted as needed

Request a free consultation with the Recruitment Innovation Center or consider the Consultations and Help resources available in the “Related Resources” section.

Population or cohort discovery

Participant or patient engagement and recruitment strategies.

Once the cohort or population has been identified, recruitment plans should consider which strategies and messaging are most appropriate to engage the intended audience, while also adhering to Federal Regulations and institutional policies and guidance.

Before identified potential participants can be recruited engagement must happen. Engagement, in this sense, is about delivering content to the right person, at the right time, with the right frequency, through the most effective channel.

True stakeholder engagement should happen as early in the study design process as possible. However, that’s not always an option when Duke is a participating site in “someone else’s research study” – when this is the case, we think of engagement as the strategies used to share information about a study with potential participants. This may include one or more of the following channels:

  • Duke Health Research Volunteer Registry
  • ResearchMatch
  • Social media (e.g., Facebook ads)
  • Print media (e.g., flyers, brochures, etc.)
  • Online/digital content (e.g., a study website or search engine ads)
  • Radio or TV spots
  • Letters or emails
  • Phone scripts for personal phone calls
  • MyChart messages

Advertising, regardless of the chosen channel(s), must follow federal regulations, Duke policies, and Duke branding requirements. Links below provide information about allowable typography, colors, use of logos, and additional tools.

  • DUHS Brand Center
  • School of Medicine Brand Guidelines
  • Duke University Brand Guide
  • DUHS Policy and Guidelines for Advertising Research
  • DOCR Social Media Recruitment SOP

Discover Duke Research 

The Recruitment Innovation Center manages the Discover Duke Research Facebook and Instagram pages and offers free social media marketing consults to all Duke research teams. During a social media marketing consult, the RIC team and investigator will work together to begin drafting a social media marketing plan to submit to the IRB for approval. Ads can be launched by the RIC from the Discover Duke Research accounts (Facebook/Instagram, Reddit, and Google) or the investigator may launch them from another approved social media channel per the Duke Social Media Recruitment SOP . RIC services (e.g., assisting in the development of a social media marketing plan, acquiring high quality images for advertising, managing the campaign, etc.,) are free of charge but there is a fee for the ads themselves.

  • Request a  social media marketing consult .
  • Review other available Policies, Procedures and Guidance in the "Related Resources" section of this page.

Duke Health Clinical Trials Directory 

The Recruitment Innovation Center manages content on the Duke Health Clinical Trials Directory . Reviewing the SIP Console Training in LMS (course #00129901) is recommended before reaching out to the RIC for assistance ( [email protected] ) in having a study posted on the Directory.

Engagement, recruitment and retention planning should take into consideration best practices for literacy, numeracy, and health literacy as well as principles of good readability. Principles of readability and tailoring to the health literacy needs of a population include adherence to the following principles:

  • Responsibility : Clear research communication is the responsibility of all stakeholders in the research enterprise
  • Life Cycle Adherence : All research communication should be clear and easy to comprehend throughout the research life cycle
  • Partnership : Research communication should be developed in partnership with the intended audience(s)
  • Cultural Sensitivity and Respect : are integral to clear communication about research
  • Tailoring : Research materials for participants should integrate literacy and health literacy practices, including plain language, numeracy, visualization and design techniques, and cultural considerations
  • Evaluation : Participant research materials should be evaluated to ensure the intended audience can understand the information
  • Confirmation : In-person communication should encourage dialogue and confirm understanding
  • Institutional Support : All stakeholders in the institutional research enterprise should support the development and implementation of organization policies that integrate literacy, numeracy and principles of good readability

Plain Language Mini Consults

The Recruitment Innovation Center offers Plain Language Mini Consults that will provide a lay-summary of the research, bulleted statements and taglines for use in advertising materials and a lay-friendly concise summary of the project that can be used in an informed consent form. Request a  Plain Language Summary today.

Patient Advisory Councils and Patient Engagement Studios

The Recruitment Innovation has expertise in patient engagement techniques, including the training, orienting and coordination of Patient Advisory Councils. They also coordinate the myRESEARCHpartners Patient Advisory Council, a group of trained and empowered patient research advocates who offer Patient Engagement Studios. Research ideas or materials can be brought to the PAC to obtain feedback, insight, advice and the lived experience of real patients in order to ensure research plans and materials are patient-centered, lay-friendly and feasible for busy people embedded in dynamic social, personal and professional lives. Complete this  request form  for a free myRESEARCHpartners Patient Engagement Studio.

Patient Advisory Council Development, Training and Coordination

For support in developing a patient advisory council for a research study, portfolio or therapeutic area, or to learn how to recruit, train and empower a group of patients to help make research more patient-centered, contact Sierra Lindo ( [email protected] ).

Engagement, Recruitment, and Retention Certificate Program

The Engagement, Recruitment, and Retention Certificate Program is a certificate and skills-building program designed for Clinical Research study teams. The intention of the program is to help staff develop and expand competency in participant engagement, recruitment, and retention.

Participant Retention Strategies

Good retention starts with a strong, feasible, well-considered engagement and recruitment plan and a participant-centered research study. Many a study has been derailed by inadequate attention to recruitment and retention barriers and lack of effective strategies to overcome them.

Approaching recruitment and retention by ensuring a protocol is participant-centered will enhance the chances of a successfully completed study that finishes enrollment on time with a strong retention rate. Being participant-centered requires an investigator to consider every element of the project from the perspective of a participant and a variety of other characteristics (e.g., relevance of the study question to them, motivation - altruism, compensation, access to novel therapy, etc. - disease state, therapeutic options and opportunity costs, etc.). Adopting both a participant-focus and a quality-by-design framework can help examine study objectives and identify the factors that are critical to achieving them, while minimizing the burden of participation for participants. In terms of recruitment and retention, this should (at minimum) include attention to the following:

  • Eligibility criteria – each criterion should be reviewed for its importance to achieving the study aims, its effect on the availability of the population and its acceptability to providers, participants and (if applicable) patient advocacy organizations.
  • Accrual feasibility – does the study population as described actually exist? Is there one (or more) particular criteria that will weed out a large number of potential participants? Are there adjustments to the eligibility criteria that should be made?
  • Adequate compensation – not all studies have the option of compensating participants. However, it’s important to consider the time, effort and hassle participants are enduring to take part in a study. Compensation in the form of money, expense reimbursement (e.g., travel, parking, meals), meaningful/useful tchotchkes or give-aways, etc., are all appropriate methods of compensating participants.
  • Study procedures and event schedules – are the study procedures, including their invasiveness and risks, length and frequency of visits and location of participation particularly burdensome for the target population?
  • Feasibility in the clinic – examine the study from the perspective of providers and clinic staff and their daily clinic operations. Will the study impact their clinic workflow? Engage them early in study design to mitigate against this risk; otherwise, ensure flexibility to minimize disruption.
  • Reducing the burden of participation – research participants are often busy people, deeply embedded in dynamic personal lives. A research study is not part of their job. Providing flexible appointment times, short visits, and convenient locations for in-person study visits can ensure that it’s easy for participants to remain in a study. Consolidate visits when possible and provide “remote” options when feasible.
  • Clear, frequent communication – Well-timed communication, including study visit reminders, via participant-preferred methods (SMS, email, phone call), an updated website, newsletters about study progress and milestones achieved, etc. are all good ways to keep participants engaged and interested in a study. Lay summaries of findings can be useful, especially if an abstract or a poster about the project is published.
  • An attitude of humble gratitude – People are not required to participate in research. Their participation is a gift to be appreciated. Frequent communication of gratitude and recognition of the time and effort participants are sharing is often cited by participants as important to their continued participation. A commitment to providing a lay-summary of the study results at the end of the study is a great way to demonstrate appreciation and turn research participants into research evangelists.

Through Innovation, Connections, Collaborations and Education, the Recruitment Innovation Center is available to help with recruitment needs. For assistance and support across the enterprise, reach out to the RIC at [email protected] or request a consult today.

clinical research recruitment techniques

A Comprehensive Guide to Clinical Recruitment Strategies

May 5, 2022

According to  ACRP , 30% of individuals withdraw from a clinical study prior to completion, and recruiting a replacement costs an average of $19,533. Psychiatry has been poised for disruption for decades, and pharmaceutical companies are looking for solutions to bridge the gap between participant recruitment and drug research and development. This blog highlights a modernized approach to patient recruitment strategies to increase the volume of qualified participants that are more likely to remain active and engaged throughout the duration of the study.

Decentralized clinical trials

Conducting decentralized clinical trials is by far the most strategic and inventive avenue for pharmaceutical companies to distinguish themselves in a space that struggles with quick and thoughtful recruitment. Traditional clinical trial settings do not allow for convenience and significantly limit the pool of qualified participants simply due to the physical location of the study site, whereas the modern approach allows pharma companies to collect data remotely, from wherever the patients are located.

Current clinical trial recruitment challenges

There are four major obstacles that traditional, in-person clinical studies fail to achieve:

  • Accessibility and convenience
  • Efficient and cost-effective recruitment
  • Diversity among participant groups
  • Strategic digital recruitment campaigns

TechCrunch  reported nearly 70% of participants live more than 2 hours away from the clinic center, and 80% of clinical trials are canceled because they fail to meet the deadline to enroll patients on time.

Decentralized clinical recruitment for precision psychiatry

In December 2021, Alto Neuroscience and Cerebral announced a first-of-its-kind partnership for a  decentralized study in precision psychiatry  that will change pharmaceutical trial recruitment forever. Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience said:

“The introduction of this first-ever decentralized clinical trial in precision psychiatry broadens our formerly narrow view of drug discovery and development in mental health, allowing us to quickly deploy effective, accessible treatments in a way not previously possible.”

This study has leveraged Cerebral’s 200,000+ member network to recruit 200 eligible participants to undergo in home-evaluations using EEG, remote assessments at milestones of the study, clinical outcomes (i.e. depression scales), and at-home visits.

Patient-centric clinical trials

Logistically speaking, considerations around the participants’ needs are not at the forefront when traditional clinical trials are designed.  Whether it's commuting to the study sites or paying out-of-pocket for expenses, site-based clinical trials burden participants and hinder the possibility of successful recruitment. In other words, patient-centricty could be significantly enhanced beyond the current traditional clinical study design.

As noted by a recent PubMed article aimed to  define patient centricity for patients as it related to clinical research studies , patient-centricity was outlined as“'Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family. Important principles for patients focused on education/information, cocreation, access, and transparency.”

Patient engagement is an essential aspect of all healthcare avenues, including the research and development of biopharmaceutical products. Patient-centric clinical trial frameworks are designed with a deep understanding of medical conditions, experiences, needs, and patient priorities (i.e. convenience, compensation, accessibility).

Leveraging an existing database

Traditional clinical trial recruitment strategies partner with labs and EHR systems to collect data on patients that could potentially qualify to participate in clinical trials.  

Reaching out to patients that meet trial eligibility criteria by using these third-party databases is a step in the right direction, but leaves your team with the responsibility to create and maintain the time-intensive recruitment campaign with quick deadlines, and participants can still be disqualified based on more specific eligibility requirements.

Clinical trial recruitment tools like Cerebral with proprietary EHRs offer an immensely competitive edge to pharmaceutical companies because of the incredibly refined data slicing and reporting capabilities. Cerebral’s structured data aggregated across prescriptions, diagnoses, labs, self-report surveys, medication fill rates, and better enables Cerebral to more rapidly and accurately identify candidates that likely meet trial eligibility criteria. 

For example, in the  Alto precision psychiatry study , Cerebral searches its patient pool for potential participants who are taking specific antidepressants, yet haven’t seen improvement in their major depressive disorder symptoms. To support further in-depth analysis of whether an individual will be a strong candidate for participation in the trial, Cerebral is able to pull details on individuals’ prescriptions, therapy frequency, comorbidities, and more. Cerebral is able to target individuals who are more likely to meet trial eligibility criteria, enabling individuals who have historically not seen any improvement in their depression systems to try a new approach to treatment, while also enabling Alto to analyze how an individual's distinct biology impacts their response to treatment. 

Recruit quickly and thoughtfully

A decentralized clinical trial program will rapidly advance the time to development of novel targeted medicines, specifically within psychiatry, a vertical in healthcare ripe for change and evolution.

By leveraging an existing database of patients and structured patient data, you can recruit quickly by creating a customized list of individuals that meet trial criteria within hours. 

Software for recruitment of patients for pharma trials

Software for recruitment of patients for pharma trials has the capability to tap into proprietary patient databases, to select pre-qualified patients that meet the eligibility parameters of the clinical trial.  Utilizing an EHR to identify relevant medical history, diagnoses, etc, allows pharmaceutical companies to target outreach to individuals who might be a good fit for a trial.

Marketing Strategy

Building a digital recruitment campaign comes with its own set of challenges.  You have to know what it takes to raise awareness and educate around clinical research, which marketing channels and formats to leverage based on your audience, and how to strategically target audiences to participate in studies.

Internal recruitment

In Cerebral’s case, our proprietary EHR and data collection capabilities enable powerful internal recruitment by having granular, detailed data about the patient base for pharmaceutical clients.  Internal recruitment as one avenue in your marketing strategy leads to much more relevant outreach and ultimately faster recruitment.

Example of a marketing campaign for clinical recruitment

Here is an example of a marketing campaign you might launch within your digital recruitment strategy:

You want to target individuals who are currently diagnosed and taking medication for bipolar I or II. Your company is conducting a clinical study for a new bipolar medication that could ease the side effects that these individuals are experiencing.  You need to consider what and where individuals are searching for when looking for alternative solutions to the current medication they are taking.  Maybe they are using Google and searching “new medication for bipolar I” or “best medication for bipolar disorder”).  You launch ads on Google targeting these keywords to drive individuals to the recruitment sign-up page.

This is just one example of what could be part of a comprehensive digital recruitment campaign.  Cerebral deeply understands the relationship between a robust data infrastructure and how it can be leveraged to strategically recruit participants.

To learn more about the capabilities and partnership opportunities with pharmaceutical companies,  visit our pharmaceutical services page .

Cerebral Inc.

Recent Posts

March 14, 2024

Managing the Anxiety and Stress of Uncertainty

March 13, 2024

Addressing Suicidal Thoughts: A Guide for Suicide Prevention

March 12, 2024

What a Manic Episode Feels Like

Take the next step to feeling better.

If you’re having a mental health emergency

If you're in emotional distress and need immediate support

For National Suicide Prevention Hotline

  • Open access
  • Published: 13 March 2024

Real-time evaluation and adaptation to facilitate rapid recruitment in a large, prospective cohort study

  • Ashley Honushefsky 1 ,
  • Eric S. Wagner 1 ,
  • Kathleen Sheridan 1 ,
  • Kathleen M. Spickard 1 ,
  • William R. LeMasters 1 ,
  • Carroll N. Walter 1 ,
  • Taryn Beaver 1 ,
  • Anne Marie Lennon 2 ,
  • Nickolas Papadopoulos 2 ,
  • Alanna Kulchak Rahm 1 &
  • Adam H. Buchanan 1  

BMC Health Services Research volume  24 , Article number:  336 ( 2024 ) Cite this article

Metrics details

Recruiting large cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. These and other challenges can lead to underrepresentation in groups such as rural residents and racial and ethnic minorities. Here we discuss the implementation of various recruitment strategies for enrolling participants into a large, prospective cohort study, assessing the need for adaptations and making them in real-time, while maintaining high adherence to the protocol and high participant satisfaction.

While conducting a large, prospective trial of a multi-cancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, adherence to the protocol, and participants’ satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol adherence and participant satisfaction.

Adaptations to methods that contributed to achieving the enrollment goal included offering multiple recruitment options, adopting group consenting, improving visit convenience, increasing the use of electronic capture and the tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for clinicians. We maintained high protocol adherence and positive participant experience as exhibited by a very low rate of protocol deviations and participant complaints.

Recruiting rapidly for large studies – and thereby facilitating clinical translation – requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study’s implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

Peer Review reports

Recruiting large cohorts in a relatively short period of time is essential to speed the translation of findings into care across a range of scientific disciplines and medical specialties. Rapid enrollment of large cohorts is important in precision medicine studies that require substantial cohorts to achieve the power necessary to compare clinical outcomes, including multi-cancer early detection (MCED) studies with regulatory implications and studies that seek to elucidate associations between genes and disease [ 1 , 2 , 3 , 4 , 5 ]. For example, the All of Us Research Program is seeking to enroll at least one million diverse participants [ 6 ]. Additionally, the National Health Service-Galleri Trial of an MCED test successfully enrolled 140,000 participants in 10 months [ 4 ]. These achievements highlight two key obstacles that researchers commonly face: recruiting underserved and underrepresented socioeconomic groups into large research studies, and recruiting on a large scale without the coordination of a national health service.

In addition to these challenges, factors such as language, financial barriers, logistical concerns, and a lack of resources for patients can prevent efficient enrollment [ 7 ]. For instance, studies enrolling older adults must overcome common recruitment challenges such as patients being too sick (too many comorbidities), patients’ families advising against participation, lack of interest, and transportation issues [ 8 ]. Recruiting among rural populations also presents distinct challenges such as geographic isolation, unique cultural and social aspects of rural settings, low population density, limited transportation, and limited access to technology, including high-speed internet [ 9 ]. Establishing procedures prior to trial start-up can maximize the success of trial implementation [ 10 ]. However, challenges arising throughout implementation may still threaten recruitment, retention, adherence to study design, and data collection, thus negatively impacting fulfillment of study aims. Therefore, the ability to identify and address such challenges in real-time is critical.

The DETECT-A study is the first interventional study of a blood-based MCED test. This test, called CancerSEEK, was used to detect cancers in older women without a history of cancer [ 11 ]. CancerSEEK screened for eight different cancer types (ovarian, liver, stomach, pancreas, esophagus, colorectum, lung, and breast cancers), which account for more than 60% of cancer deaths [ 11 ]. Participants had a blood draw, and those with a positive MCED test proceeded to whole body PET-CT scan for confirmation and localization of the tumor [ 11 ]. Enrollment and recruitment for DETECT-A was conducted at Geisinger, a single, partially integrated healthcare system spanning 45 counties in Pennsylvania, 35 of which are designated as rural. Geisinger was chosen as the recruitment site due to several features that were anticipated to facilitate recruitment.

By virtue of its large, stable, aging patient population and 25-year use of an electronic health record that can be queried for potentially eligible individuals [ 5 , 12 ], investigators hoped to enroll 10,000 participants in 18 months. The purpose of this manuscript is to discuss the implementation of various recruitment strategies for enrolling participants into a large, prospective cohort study, assessing the need for adaptations and making them in real-time, while maintaining high adherence to the protocol and high participant satisfaction.

DETECT-A study overview

DETECT-A evaluated the feasibility and safety of incorporating a multi-cancer early detection blood test into routine clinical care [ 11 ]. To analyze these outcomes, the study was designed to enroll 10,000 women, between the ages of 65–75, who had no prior history of cancer, in order to provide greater than 99% power to detect 20 or more cancers [ 11 ]. Recruitment began in August 2017 and enrollment was anticipated to be completed in 18 months. Study procedures are summarized in Fig.  1 and described in detail elsewhere [ 11 ]. Recruitment efforts, baseline enrollment visits, and follow-up activities overlapped chronologically, making it important to rapidly assess and adapt strategies to ensure that recruitment goals, protocol adherence, and patient satisfaction were simultaneously achieved (Fig.  2 ). Here we report the initial procedures for achieving the recruitment goal and methods for tracking processes and outcomes. Adaptations based on the results of process tracking are summarized in Results.

figure 1

DETECT-A study design summary

figure 2

Enrollment and 1-year follow-up timeline showing staffing needs

Initial plan

The initial study team comprised two project managers, four research assistants, and one research phlebotomist, all of whom were fully funded by the study. Enrollment commenced at two locations where study staff had permanent office and/or clinic space. Initial recruitment methods included flyers, targeted mailings, and referrals from study staff and participants. Flyers that included a study phone number were displayed in Geisinger elevators and waiting areas in primary and specialty departments. Targeted mailings were sent in 101 batches (of fewer than 500 letters) to potentially eligible individuals who were identified by querying Geisinger’s electronic health record (EHR). Letters included return postcards and a phone number for recipients to express their interest or disinterest in participating. The letter explained that if we did not hear from them, we might call them in the future to assess their interest.

Measures of implementation

Tracking and monitoring techniques to assess the recruitment progress, adherence to protocol procedures, and participants’ satisfaction are summarized below.

Recruitment procedures

Due to the size of the cohort for this study, data were structured into several specialized Research Electronic Data Capture (REDCap) [ 13 ] databases. Access to these databases was given to staff based on their assigned study tasks (Fig. 3 ). The Recruitment Database was used to manage and monitor participant interest and progression throughout the study and provide weekly screening and enrollment metrics to the study collaborators. The study team used REDCap data to create Power BI dashboards to routinely assess important metrics such as the number of unfilled informed consent discussion appointment slots, and the recruitment and follow-up call assignments. If appointment slots were not being filled adequately, recruitment strategies and staff priorities were adjusted as needed (see Results). When potential participants were not interested in attending an enrollment event at currently available locations, we tracked their preferred location in REDCap and considered adding these locations as enrollment sites.

figure 3

Outline of REDCap Databases, Dashboards and Reports. a The Recruitment Database was used to track recruitment activities for all potential participants that were sent a recruitment letter and anyone who responded to flyers, social media, or other recruitment methods. b The Visit Database was used to document enrolled participants’ CancerSEEK results and baseline visit data. c The Clinical Follow-up Database was used to collect follow-up data on those who completed a PET-CT scan, including cancer diagnoses. d The Year 1 Survey Database was used to collect Year 1 survey data, and to allow Geisinger’s Survey Research Core to administer surveys without needing training on the other databases

Protocol adherence procedures

Tracking and monitoring of protocol activities that occurred throughout the study were complex, requiring flexibility and coordination of study staff. Staff members were divided into ‘teams’ that had different priorities and tasks (Table 1 ). Each team monitored daily tasks and problem-solved in real time. Study activities were collected and tracked on paper, in the participants’ EHR, in the study REDCap databases, and in electronic files (Table 2 ). In addition to tracking and monitoring, the team was trained to identify potential issues proactively so that we could adapt to situations as needed. Protocol deviations and protected health information (PHI) breaches were handled immediately, documented in electronic spreadsheets and REDCap databases, and reported to the Geisinger’s institutional review board (IRB) at continuing review.

Participant experience procedures

Throughout the study, any concerns relating to a visit location were reported to a study coordinator. Participants were also encouraged to contact the study’s genetic counselors for questions about their results, and the study team or Geisinger’s IRB with any general problems, questions, or concerns.

The DETECT-A study enrolled 10,007 participants over the course of 22 months, which was four months longer than our anticipated timeline. Table 3 shows a monthly breakdown of adaptations to the recruitment methods and locations used to achieve the enrollment goal. Adaptations to our recruitment, enrollment, protocol, and participant experience processes are summarized in Table  4 . All adaptations required submission to the IRB as amendments and were approved accordingly. A common theme that emerged was the need to increase participant-centered flexibility in recruitment and enrollment procedures. A variety of methods were used for participants to express interest in participation, including by returning a postcard, calling the study team, or completing an eligibility questionnaire online. Visit locations were expanded to 22 sites from which the participants could choose. During recruitment visits participants could also choose to be a part of a group or an individual consenting session.

Recruitment procedures – problems and consequences

We identified several challenges in the initial recruitment method used in the first two months (Table  4 ). The time it took for potential participants to return the postcards indicating they were interested resulted in some of them no longer meeting eligibility criteria, which impacted our ability to fill appointment times at study visits. Management of the recruitment mailing process and return postcards was also labor intensive for the staff, which limited their availability for visits. The graphic design of the initial recruitment materials (i.e., invitation letters and return postcards) were bland and did not elicit interest from recipients who doubted their authenticity. Mailings were limited to Geisinger patients, which resulted in a smaller pool of potentially eligible participants early in the study. Finally, mailings and flyers alone did not generate a sufficient number of interested participants in a timely manner to meet weekly enrollment targets.

Recruitment procedures–solutions

To reduce response turnaround time from the initial recruitment methods, modifications were made to the targeted mailing process and to the flyers. The printing and the mailing of recruitment materials were both outsourced to Geisinger’s Digital Print and Mail Center. Geisinger’s Marketing & Communications department created recruitment content with more engaging graphic design. Postcards were eliminated to make the recruitment process more time efficient. We also supplemented our recruitment efforts with methods designed to reach non-Geisinger patients, including advertisements (social media, news media, newsletters, flyers), referrals from participants, and community outreach (Table  4 ). Both targeted and broad recruitment methods were used in tandem, as necessary solutions to meet weekly recruitment targets (Fig.  4 ).

figure 4

Percent yield. Percentages shown above represent the number of participants who enrolled in the study by recruitment method category. Targeted recruitment methods focused on individuals who were more likely to meet inclusion/exclusion criteria. Broad methods reached a larger population that resulted in a lower percentage of eligible individuals. Mass mailings and social media advertisements resulted in the highest yield of interested and eligible individuals

Additionally, Facebook advertisements were created using demographic and geographic parameters. Readers who clicked the ad were routed to the DETECT-A website, where they were provided with contact information for the study team and given the opportunity to complete an eligibility questionnaire. The study team reviewed the eligibility of each submission, including EHR review for Geisinger patients. An email was sent to individuals if they were not eligible. Individuals who were potentially eligible received a phone call where inclusion/exclusion criteria were confirmed. Social media recruitment, which had a link to opt-in electronically that directly alerted the study staff, had the quickest response time from potential participants compared to other recruitment methods. At the end of the study, mass mailings had the highest yield of interested and eligible individuals accounting for 95% of those who enrolled in the study. Social media advertisements followed with 4% (Fig.  4 ).

To broaden our reach of potential study candidates, study staff participated in multiple community outreach events where the target population was represented, such as local community fairs, health and wellness fairs, and community luncheons for older individuals. Stories about the DETECT-A study and its investigators were featured in local newspapers, on Geisinger-sponsored televised health segments, and on local news programs. Upcoming enrollment events were highlighted in standing communications from Geisinger to members of the Geisinger Health Plan (GHP) [ 14 ], Silver Circle [ 15 ], and other large Geisinger research projects like the MyCode Community Health Initiative [ 16 ].

Study staff placed the flyers in new locations, including wellness centers, senior centers, churches, and local businesses. Currently enrolled DETECT-A participants were encouraged to share study flyers with other potential participants. Since this approach was successful, we developed a “Refer-a-Friend" mailing campaign for the last 6 months of enrollment (see Table  3 ). Participants who referred eligible friends and family during a designated time frame were entered into a one-time gift card drawing. All remaining recruitment methods mentioned above contributed to 1% of those who enrolled in the study (Fig.  4 ).

Enrollment procedures–problems and consequences

Enrolling individuals presented additional challenges beyond those encountered during recruitment. Interested individuals were sometimes unwilling or unable to travel to available enrollment locations to provide informed consent, negatively impacting enrollment numbers. Individual informed consent sessions resulted in consenter fatigue, a lower daily capacity for enrollment, and a loss in productivity when potential participants canceled or did not show for scheduled appointments. Recruitment efforts and enrollment events competed for staff time, which was reflected in fluctuating enrollment numbers from month to month. Months with heavy enrollment meant staff were largely deployed to visits, which were then followed by months with unfilled appointment slots as staff had less time to devote to recruitment calls (Fig.  2 ).

Enrollment procedures–solutions

We organized two teams to meet recruitment, enrollment, and other study activity demands (Table  1 ). The Visit and Office Teams’ tasks were prioritized in categories of time sensitive versus time flexible. Visit logistics were designed to allow for efficiency when the Visit Team became mobile. Staff traveled in study vehicles to the enrollment locations with tables, chairs, lab kits, phlebotomy supplies (including snacks and water for participants post blood draw), signage, and paperwork. Over the 22 months of recruitment, locations were expanded to a total of 22 sites across the Geisinger service area based on feedback from recruitment calls (Table  3 ). These sites included Geisinger and non-Geisinger spaces. The Geisinger spaces consisted of exam rooms, conference rooms, multipurpose rooms, employee breakrooms, community rooms, and the Geisinger Commonwealth School of Medicine. Non-Geisinger spaces included a community center, an athletic facility, and an indoor courtyard.

Hourly scheduled group consenting sessions were instituted. The size and the number of groups were determined by site layout and staffing. The ideal layout was a large open room where participants could move through stations that were staffed to conduct informed consent sessions, surveys, and blood draws. Maintaining flexibility in staffing meant that one consenter could meet with up to 15 participants at once or multiple consenters could meet with smaller groups, all while continuing to accommodate requests for individual consenting. Post-consent blood draws and survey completion could occur in either order depending on the size of the group. Overbooking appointments lessened the impact of cancelations and no-shows. Late participants were provided a copy of consent and asked to wait for the next scheduled session. The group consenting model allowed for adequate staff rest breaks between sessions and increased the number of consented participants per day by 2–5 times (up to 103 participants per day).

We cross-trained fully funded staff and employed research support department staff to assist with recruitment phone calls, conducting informed consent, and blood draws, which freed up fully funded staff for office tasks (Fig.  2 ). We utilized Geisinger’s Survey Research Core to assist with recruitment calls, scheduling, and survey administration, allowing us to expand these activities to nights and weekends. We were able to leverage additional system-wide internal resources, such as having Research Assistants train at Geisinger’s School of Phlebotomy to perform venipunctures, which expanded our team of research phlebotomists and improved visit efficiency. Genetic counselors and clinicians were part of a Multidisciplinary Review Committee for the study, who reviewed CancerSEEK positive results and recommended next steps.

Effort was tracked by Project Managers who viewed and reconciled monthly expense and effort reports provided by Research Finance. Genetic counselors and clinicians who were Sub-Investigators on the study billed time and effort to the study. The clinicians who saw participants after a PET-CT scan charged their time as a level of service for that visit, not through time and effort. Level of service costs were billed to the study, not to the participant or their insurance.

In total, 111 employees billed their time and effort to the study during the 22 months of recruitment and the first 12-months of follow-up, which translated to an average of 15.28 full-time equivalent (FTE) during recruitment and follow-up. This included managers at 2.80 FTE, research assistants and coordinators at 4.30 FTE, phlebotomists at 2.47 FTE, cross trained phlebotomists at 1.70 FTE, administrative secretaries at 0.73 FTE and support staff at 3.28 FTE. These diverse staffing resources allowed for division of labor by area of expertise. Additionally, our core staff was cross trained for both office and visit tasks (Table  1 ), which gave us the flexibility to adapt procedures in real time as the study demanded.

Protocol adherence procedures–problems and consequences

We had four types of protocol deviations: using outdated informed consent (ICF) versions, enrolling more participants than were IRB-approved, misplacing original ICFs, and signing an ICF after completing venipuncture. There were two types of PHI breaches reported to the privacy office, including a mix-up of paperwork at the visits, and mailing paperwork to the wrong participant. There were two issues of non-compliance for unauthorized disclosure of health information for internally providing a patient list that included PHI to a statistician who was not yet added to IRB study application and accidental sharing of unapproved PHI on an internal and private group communication board. Table 4 details the problems that resulted in adaptations to our processes. It was determined the problems and consequences were largely related to the use of paper source documents, which were inefficient, time-consuming, and vulnerable to human errors.

Protocol adherence procedures–solutions

Protocol deviations.

To avoid future protocol deviations, it was necessary to periodically retrain staff on certain processes. For complex and technical tasks, we designated a point person to have primary responsibility to decrease protocol errors. For example, an assigned staff member exported reports to generate appointment sheets, which led to better organization and easier identification of participants’ visit types at each visit. Multiple staff were retrained as backups and were used when needed on that assignment. Identification of visit types were key because participants were at different stages of the study. For instance, a baseline visit included the informed consent process, completion of a study developed questionnaire ( Supplemental Baseline Questionnaire 1 ), and a blood draw versus follow up blood draw or redraw appointments for those participants who were already consented into the study.

We implemented checks throughout large visit days to ensure all ICFs were signed and filed appropriately, which enabled us to identify missing signatures or forms and obtain them before the participant left the visit.

PHI breaches

To facilitate adherence to the protocol procedures, each participant was given a folder at the start of the visit containing the inclusion/exclusion verification sheet, gift card confirmation, and phlebotomy form, as well as the ICF and baseline survey. The participant kept the folder with them throughout the visit. At the conclusion of their visit, study staff retrieved original paperwork from the folder and returned copies of the ICF and gift card confirmation form to the participants.

Participant experience procedures–problems and consequences

Four of the 22 enrollment sites presented challenges that were identified by participants using a patient-satisfaction survey. Dissatisfaction included limited parking, privacy concerns, lack of signage directing participants to visit areas, and limited facility oversight at non-clinic sites. Of clinical importance, five participants who underwent a PET-CT scan reported anxiety due to prolonged wait times between imaging and result disclosure. Also, there were complaints related to study design. For example, three participants that had a negative CancerSEEK test were upset they did not hear from the team again until it was time to complete their Year 1 survey. We also had three participants who were upset that they were diagnosed with cancer despite their CancerSEEK test being negative.

Participant experience procedures–solutions

We discontinued use of enrollment sites that prompted multiple participant complaints. To improve participant experience at remaining sites, we altered visit set-ups, provided more detailed parking instructions, and displayed portable study signage. It was also necessary for the core study staff to take more responsibility at sites that lacked operational management.

We increased the number of clinician investigators on the study to assist with the timely return of negative and positive PET-CT scan results. Study staff triaged the findings to the appropriate study clinicians. Specifically, primary care physicians on the study were enlisted to return imaging findings that were not concerning for cancer. This allowed study oncologists to focus on only returning the findings suggestive of cancer. In all instances, participants’ primary care physicians were also notified of the results and recommended next steps via EHR message, fax, or phone call. We did not address the study design concerns participants raised but we did offer genetic counseling visits for those who were upset by their result, a new cancer diagnosis, or wanted further information.

The effective and efficient recruitment of large numbers of individuals over short time periods is critical to translating research findings into practice [ 1 , 2 , 12 ]. The lessons learned from the successful recruitment into a large, prospective cohort study, DETECT-A, can inform future large recruitment efforts and foreshadow important clinician- or patient-level implementation obstacles to be anticipated. Our findings in a rural, aging population highlight successful recruitment strategies and the importance of real-time data-driven adaptations to these strategies. These results, which are consistent with recent recruitment literature [ 17 , 18 , 19 , 20 ], demonstrate the importance of iterative adaptation to a priori recruitment and enrollment strategies based on timely evaluation of available data as key to our study’s ability to meet enrollment targets [ 20 ]. Using existing data capture systems like REDCap [ 13 ] can streamline the ease with which data from these recruitment strategies can be analyzed.

The most impactful adaptations to recruitment strategies identified were related to group consenting, staffing, and participant experience. These solutions may be effective within other study designs and organizational contexts. A variety of methods were used for participants to express interest in participation, including by returning a postcard, calling the study team, or completing an eligibility questionnaire online. Initially, the study used individual consenting sessions, as is typical in many studies. It was quickly apparent from enrollment figures that this approach was inefficient and recruitment goals would not be reached in the necessary timeframe. Shifting to a group consenting format resulted in efficiencies that facilitated the ability to reach goals on target without negatively impacting adherence to study protocol. Anecdotally, we observed that group consenting enhanced conversational dynamics and allowed for deeper and more meaningful discussion of the informed consent form, an experience consistent with the impact of group dynamics in clinical settings [ 21 , 22 , 23 , 24 ]. We recommend using a variety of strategies, particularly when attempting to overcome recruitment barriers among populations underrepresented in research [ 19 ]. For example, even with the increase in popularity of e-consenting and remote visits, studies seeking to enroll elderly participants may choose to maintain in-person consenting visits as an option for individuals who are less comfortable with computers or do not have access to a computer or device. Studies involving a blood draw or other procedures would still require an in-person interaction thus using multiple strategies (e.g., offering informed consent by telephone, chatbot, telehealth, and in-person) offers opportunities to be as inclusive as possible and limit selection bias.

Our experience also underscores challenges of, and potential solutions to, recruiting in rural settings. Geisinger’s service area is predominantly rural, and covers a large geographic area, which sometimes required participants to travel long distances to reach an enrollment location. Rural populations can and should have the opportunity to participate in research studies in spite of geographic distance; our effort to utilize multiple enrollment spaces was successful in attracting these participants. We selected local Geisinger clinics and trusted community spaces that were familiar to our population, such as community centers and athletic facilities. Our expanding recruitment efforts and study activities required a rapid increase in study staff, and this increased staff size allowed us to expand to many of the requested locations that were more convenient for participants. Some of these locations were in less populous areas, so by scheduling at more than one site per day we were able to use staff time more efficiently while meeting daily enrollment targets. The study leased two vehicles for staff travel to cover the additional visit sites.

Another important lesson was to not undertake tasks for which other groups are experts. For example, we utilized resources at Geisinger such as Marketing and Communications and the Digital Print and Mail Center in the design of posters and other recruitment materials. In addition, we found that adding small efforts from several staff members outside the core study team can meaningfully supplement the team’s capacity to focus on participant-centered enrollment. For interventional trials, integrating the disclosure of study results easily and seamlessly into routine clinical care without adding unfunded work for clinicians is key [ 18 ]. We did this by triaging the findings to the appropriate study clinicians, allowing study oncologists to focus on only returning the findings suggestive of cancer. We also notified the participants’ primary care physicians of the results and recommended next steps via EHR message, fax, or phone call.

When it comes to capturing and tracking data and source documents, we recommend electronic capture mechanisms whenever possible. Robust electronic tracking of study processes allows the team to identify ineffective processes, adapt quickly based on data, and avoid protocol deviations. It is also critical to link multiple databases when applicable. We initially thought that having a separate REDCap database for each subset of participants as they progressed through the study would make data management easier and quicker. However, we recommend using a single database whenever possible, as the administrative burden of transferring essential data between databases, and updating critical fields in multiple places, was significant, and prone to data entry errors.

Though we did not intend to do so from the outset, we used several of the implementation strategies described by Powell et al., including changing service sites, developing and implementing tools for quality monitoring, and promoting adaptability [ 25 ]. As we adapted recruitment strategies throughout the study, we realized, as others have, the importance of considering implementation strategies and associated outcomes during study planning [ 17 ]. That approach could have allowed us to focus on assessing racial and ethnic representation in the DETECT-A cohort and implementing strategies to improve diversity. Such strategies would include translating all recruitment and patient-facing study materials into multiple languages and training research staff on the many medical interpreter resources used by clinic staff to effectively communicate in patients’ preferred languages. The importance of this missed opportunity is highlighted by a post-hoc comparison that found the DETECT-A cohort to be significantly less racially and ethnically diverse (Chi-square = 420.45, p  < 0.001 and Chi-square = 1001.86, p  < 0.001, respectively) than the overall female Geisinger population of the same age range. As noted by Swanton et al., it could be useful to track the “number needed to invite”—the number of invitations that need to be sent to achieve one person enrolled into a study – and determine whether this number differs between groups [ 4 ]. We missed an opportunity to collect race and ethnicity of all invited individuals during our recruitment phase, preventing us from comparing recruitment rates by race or ethnicity. Collecting age, gender, race, ethnicity, geographical area, and socioeconomic variables during recruitment could be beneficial to calculate the number needed to invite among various categories. Evidence from other cancer screening studies has shown that robust, sustained engagement in underrepresented communities and shared decision making can encourage enrollment of diverse cohorts [ 26 ]. Identifying and understanding the distinct barriers of diverse populations is an important step to improving outreach and communication with people. Allocating resources and costs to fully engage those underserved populations is key.

Based on our experiences in the DETECT-A study, our key findings can be summarized by these five recommendations to consider from the outset of a clinical research study: 1. offering multiple recruitment and consenting options, especially with older participants, as they may be less comfortable with using or don’t have access to a computer or device and prefer in-person visits 2. offering research visits at many clinics and trusted community organizations in rural areas that are frequently visited, such as community centers and athletic facilities 3. identifying and utilizing available resources and teams so that the core study team could focus on participant-centered enrollment, and for interventional trials integrating the disclosure of study results easily and seamlessly into routine clinical care without adding unfunded work for clinicians 4. capturing and tracking data and source documents electronically as much as possible and finally 5. using an implementation science framework, adaptation tracking, and various implementation strategies to address needs from the beginning of the study. In closing, including metrics aligned with the measurement of adaptations, such as who instituted what, when, and why, and using any of the frameworks as described in implementation science would improve post-hoc analysis of the impact and the value of individual strategies and allow for further transparency in value trade-offs to improve generalizability to other contexts [ 27 , 28 , 29 , 30 , 31 ]. By acknowledging these limitations, we hope that the post-hoc analysis of implementation outcomes described in this manuscript will be valuable for informing future measurements and tracking adaptations.

Recruiting rapidly for large prospective cohort studies – and thereby facilitating clinical translation – requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study’s implementation outcomes prior to study recruitment can support recruitment of a diverse and representative cohort and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

Availability of data and materials

All data generated and/or analyzed during this study are included in this published article and its supplementary information files.

Abbreviations

Multi-cancer Early Detection

Electronic Health Record

Research Electronic Data Capture

Protected Health Information

Institutional Review Board

Geisinger Health Plan

Full-time equivalent

Informed Consent Form

Liu MC, Oxnard GR, Klein EA, et al. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2021;31(6):745. https://doi.org/10.1016/j.annonc.2020.02.011 .

Article   Google Scholar  

The All of Us Research Program Investigators. The “All of Us” research program. N Engl J Med. 2019;381:668–76.

Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402(10409):1251–60. https://doi.org/10.1016/S0140-6736(23)01700-2 .

Swanton C, et al. NHS-Galleri Trial Design: Equitable study recruitment tactics for targeted population-level screening with a multi-cancer early detection (MCED) test. JCO. 2022;40:TPS6606–TPS6606. https://doi.org/10.1200/JCO.2022.40.16_suppl.TPS6606 .

Carey DJ, Fetterolf SN, Davis FD, et al. The Geisinger MyCode community health initiative: an electronic health record–linked biobank for precision medicine research. Genet Med. 2017;18(9):906. https://doi.org/10.1038/gim.2015.187 .

Ramirez AH, Sulieman L, Schlueter DJ, et al. The all of us research program: Data quality, utility, and diversity. Patterns. 2022;3(8). https://doi.org/10.1016/j.patter.2022.100570 .

Nipp RD, Hong K, Paskett ED. Overcoming Barriers to Clinical Trial Enrollment. American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting. 2019;39:105–14. https://doi.org/10.1200/EDBK_243729 .

Forsat ND, Palmowski A, Palmowski Y, Boers M, Buttgereit F. Recruitment and retention of older people in clinical research: a systematic literature review. J Am Geriatr Soc. 2020;68(12):2955. https://doi.org/10.1111/jgs.16875 .

Article   PubMed   Google Scholar  

Kim NH, Wilson N, Mashburn T, et al. Lessons learned recruiting a diverse sample of rural study participants during the COVID-19 pandemic. Int J Drug Policy. 2021;97. https://doi.org/10.1016/j.drugpo.2021.103344 .

Greer TL, Walker R, Rethorst CD, et al. Identifying and responding to trial implementation challenges during multisite clinical trials. J Subst Abuse Treat. 2020;112:63. https://doi.org/10.1016/j.jsat.2020.02.004 .

Lennon AM, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020;369:eabb9601. https://doi.org/10.1126/science.abb9601 .

Berger PB, Henry Y, Harkins V, Ferrari A. Use of an electronic health record to optimize site performance in randomized clinical trials. J Clin Trials. 2015;05(01). https://doi.org/10.4172/2167-0870.1000208 .

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2010;42(2):377. https://doi.org/10.1016/j.jbi.2008.08.010 .

Geisinger health plan. https://www.geisinger.org/health-plan . Updated 2024. Accessed 11 Feb 2022.

Silver circle. https://www.geisinger.org/health-and-wellness/silver-circle . Updated 2024. Accessed 11 Feb 2022.

MyCode community health initiative. https://www.geisinger.edu/gchs/research/mycode . Updated 2024. Accessed 11 Feb 2022.

Ahonkhai AA, Wudil UJ, Dankishiya FS, et al. Strategies for successful clinical trial recruitment of people living with HIV in low- and middle-income countries: lessons learned and implementation implications from the Nigeria renal risk reduction (R3) trial. Curr HIV/AIDS Rep. 2021;18(4):289. https://doi.org/10.1007/s11904-021-00566-x .

Article   PubMed   PubMed Central   Google Scholar  

Taft T, Weir C, Kramer H, Facelli JC. Primary care perspectives on implementation of clinical trial recruitment. J Clin Trans Sci. 2019;4(1):61. https://doi.org/10.1017/cts.2019.435 .

Masese RV, Demartino T, Bonnabeau E, et al. Effective recruitment strategies for a sickle cell patient registry across sites from the sickle cell disease implementation consortium (SCDIC). J Immigrant Minority Health. 2020;23(4):725. https://doi.org/10.1007/s10903-020-01102-6 .

Huang B, De Vore D, Chirinos C, et al. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019;19(1). https://doi.org/10.1186/s12874-019-0679-y .

Lieberman MA, Golant M, Altman T. Therapeutic norms and patient benefit: cancer patients in professionally directed support groups. Group Dyn Theory Res Pract. 2004;8(4):265–76. https://doi.org/10.1037/1089-2699.8.4.265 .

Shaw ME. Group dynamics: The psychology of small group behavior. New York: McGraw-Hill College; 1981.

Google Scholar  

Wilson SR. Individual versus group education: is one better? Patient Educ Couns. 1997;32(1 Suppl):S67–75. https://doi.org/10.1016/s0738-3991(97)00098-0 .

Shechtman Z, Toren Z. The association of personal, process, and outcome variables in group counseling: testing an exploratory model. Group Dyn Theory Res Pract. 2010;14:292–303.

Powell BJ, Waltz TJ, Chinman MJ, et al. A refined compilation of implementation strategies: Results from the expert recommendations for implementing change (ERIC) project. Implementation Sci. 2015;10(1). https://doi.org/10.1186/s13012-015-0209-1 .

Thompson C, Buchanan A, Myers R, Weinberg DS. Integrating primary care, shared decision making, and community engagement to facilitate equitable access to multi-cancer detection clinical trials. Front Oncol: Cancer Epidemiol Prev. 2023;13. https://doi.org/10.3389/fonc.2023.1307459 .

Glasgow RE, Battaglia C, Mccreight M, Ayele RA, Rabin BA. Making implementation science more rapid: Use of the RE-AIM framework for mid-course adaptations across five health services research projects in the veterans health administration. Front Public Health. 2020;8. https://doi.org/10.3389/fpubh.2020.00194 .

Treichler EBH, Mercado R, Oakes D, et al. Using a stakeholder-engaged, iterative, and systematic approach to adapting collaborative decision skills training for implementation in VA psychosocial rehabilitation and recovery centers. BMC Health Serv Res. 2022;22(1). https://doi.org/10.1186/s12913-022-08833-2 .

Mccarthy MS, Ujano-De Motta LL, Nunnery MA, et al. Understanding adaptations in the veteran health administration’s transitions nurse program: Refining methodology and pragmatic implications for scale-up. Implementation Sci. 2021;16(1). https://doi.org/10.1186/s13012-021-01126-y .

Moullin JC, Nevedal A, Mccreight M, et al. Using a longitudinal multi-method approach to document, assess, and understand adaptations in the veterans health administration advanced care coordination program.

Smith JD, Norton WE, Mitchell SA, et al. The longitudinal implementation strategy tracking system (LISTS): Feasibility, usability, and pilot testing of a novel method. Implement Sci Commun. 2023;4(1). https://doi.org/10.1186/s43058-023-00529-w .

Download references

Acknowledgements

The authors are grateful for the hard work of the DETECT-A study team for the successful implementation of a large-scale study, as well as the Geisinger Research departments mentioned in the paper. We also want to thank the 10,007 dedicated women who joined the study and volunteered their time to research.

This work was supported by Marcus Foundation through Johns Hopkins University.

Author information

Authors and affiliations.

Geisinger, 549 Fair Street, Bloomsburg, PA, 17815, USA

Ashley Honushefsky, Eric S. Wagner, Kathleen Sheridan, Kathleen M. Spickard, William R. LeMasters, Carroll N. Walter, Taryn Beaver, Alanna Kulchak Rahm & Adam H. Buchanan

The Johns Hopkins Institutions, Baltimore, MD, USA

Anne Marie Lennon & Nickolas Papadopoulos

You can also search for this author in PubMed   Google Scholar

Contributions

AH, AB, KS, KMS, TB, EW, CW, WL were involved with the study design, data collection, analysis, preparation of figures, and write-up. AR, AL, and NP assisted with the analysis and write-up. All authors reviewed and contributed to the revisions to the article.

Corresponding author

Correspondence to Ashley Honushefsky .

Ethics declarations

Ethics approval and consent to participate.

Geisinger’s Institutional Review Board reviewed and approved this study. Written informed consent was obtained from the participants. The authors report that all experiments were performed in accordance with relevant guidelines and regulations such as the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Supplementary material 1., rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Honushefsky, A., Wagner, E.S., Sheridan, K. et al. Real-time evaluation and adaptation to facilitate rapid recruitment in a large, prospective cohort study. BMC Health Serv Res 24 , 336 (2024). https://doi.org/10.1186/s12913-024-10750-5

Download citation

Received : 24 October 2023

Accepted : 19 February 2024

Published : 13 March 2024

DOI : https://doi.org/10.1186/s12913-024-10750-5

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

  • Adaptations
  • Implementation outcomes
  • Rapid recruitment
  • Large cohort
  • Protocol adherence
  • Positive participant experience
  • Group consenting

BMC Health Services Research

ISSN: 1472-6963

clinical research recruitment techniques

clinical research recruitment techniques

Insights & News

5 key strategies for clinical trial patient recruitment.

Are you interested in learning more about clinical trial patient recruitment strategies? If so, then you’ve come to the right place! A successful trial depends on the recruitment and retention of patients, which can be a challenging process, but this is an essential element for the completion of your trial.

One of the most important steps in developing and testing novel medical treatments is conducting a clinical study. Unfortunately, we can see numerous studies being closed or delayed due to poor recruitment.

Let’s review the best practices for recruiting patients for clinical trials, such as ways for identifying and contacting prospective participants, as well as strategies to keep them engaged throughout the whole duration of the clinical trial. We’ll also review how working with a therapeutically aligned contract research organization (CRO) for your study can alleviate some of the challenges you may encounter in your study’s patient recruitment journey.

clinical research recruitment techniques

Table of Contents:

  • 5 key strategies to consider for successful patient recruitment

How can a CRO like Proxima help with patient recruitment?

You've got a plan, a potential therapy, medicine, or device, and you're ready to start clinical trials. But do you really know what it takes to successfully bring your product to market? A patient-centric approach! Let's take a look at some of the best techniques for patient recruitment in clinical trials.

The 5 key strategies to consider for successful patient recruitment

1. Identify your patient population: Before you start recruiting patients, it's important to have a clear understanding of who you're targeting. This might involve identifying particular age groups, genders, or other demographic traits, along with the medical condition and treatment being studied.

2. Use a wide variety of recruitment methods: To increase your chances of success, it's advisable to use multiple methods for reaching potential clinical trial participants. This might include placing ads in local newspapers or on websites, working with patient advocacy groups or healthcare providers, or using social media to help spread the word.

3. Make it easy for potential participants to get information: When people are considering participating in a clinical trial, they will have questions. Whether it's through a dedicated website, a toll-free hotline, or in-person information sessions, it's important to make it as effortless as possible for them to get the information they need.

4. Offer incentives: Even though most people who participate in clinical trials do so because they want to promote medical research, it can be useful to provide other incentives to participants. This might involve receiving payment for their time and travel or receiving free medical attention or treatment.

5. Keep participants engaged: Once someone has decided to take part in a clinical trial, you now need to keep them motivated to stay in the trial. This could involve giving regular updates on the trial's progress, providing support and resources to help participants handle any challenges or adverse effects, and being sure to answer any questions or concerns they may have along the way.

It's also worth mentioning that there are a few things to avoid when it comes to patient recruitment in clinical trials. For example, it's important to ensure that you're not coercing or pressuring people into participating. You’ll also need to fully disclose all relevant information about the trial and any potential risks associated with their participation. Also be sure to consider cultural and language differences, making sure that trial materials and communications are accessible and understandable to all participants. 

Being proactive and working with a clinical trial partner early in the process can help to create a patient recruitment plan that tackles the recruitment barriers mentioned above.

Choosing a knowledgeable and experienced CRO capable of leveraging the right relationships has a direct impact on patient recruitment. Proxima has experience in 27+ therapeutic areas for medical devices and drug development, so our team can quickly identify the needs and goals of your trial to then help select the most patient-centric clinical site for your study. Having a well-run, professional site means that patients will have more autonomy, conveniently accessible tools, and resources, and will be well-informed about their responsibilities and expectations. 

You need a capable CRO with strong site relationships that will provide you with open communication and trust, resulting in improved patient recruitment and retention, as well as trial outcomes.

We also help you put your protocol into action by helping you identify the study population, criteria, and recruitment objectives, as well as assisting you through the protocol submission process to the IRB. We can remove any barriers that stand in the way of a clinical trial's effective recruitment and success by combining our expertise in data administration, site partnerships, and patients' needs.

Overall, patient recruitment for your clinical trial will require careful thought and planning, but with the appropriate strategies in place, you can effectively enroll the patients you need on time. Simply following the recommended practices stated above will increase your chances of improving the field of medicine with speed and agility.

clinical research recruitment techniques

  • Open access
  • Published: 16 October 2014

Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities

  • Peter Bower 1 ,
  • Valerie Brueton 2 ,
  • Carrol Gamble 3 ,
  • Shaun Treweek 4 ,
  • Catrin Tudur Smith 5 ,
  • Bridget Young 6 &
  • Paula Williamson 5  

Trials volume  15 , Article number:  399 ( 2014 ) Cite this article

30k Accesses

237 Citations

28 Altmetric

Metrics details

Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions.

In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions.

Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives.

Conclusions

Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.

Peer Review reports

There is currently a worldwide drive to enhance health, wellbeing, and wealth through effective research and dissemination. In the United Kingdom, the overarching vision of the National Institute for Health Research (NIHR) is to see ‘more patients and health professionals participating in health research’ [ 1 ].

A critical part of the health research portfolio is the testing of interventions through randomized controlled trials. Trials can range from highly controlled explanatory trials through to pragmatic trials of new health technologies and models of service delivery. A large number of trials are dependent on the willingness of patients and professionals to give their time and effort to participate. If high levels of participation (through recruitment to the study and longer-term retention) are not achieved, this has implications for statistical power, internal validity, and external validity. Recruitment problems also have practical and financial impacts, as they can delay completion of research or reduce its timely impact on patient health and wellbeing.

Achieving appropriate levels of patient and professional participation has been a significant obstacle to evidence-based practice. Published data show that the minority of trials recruit successfully, either in terms of reaching their planned sample size, or delivering the planned sample in the expected recruitment window [ 2 , 3 ]. Although there may have been improvements since these initial surveys, related in part to the significant investment in infrastructure [ 4 ], problems still remain [ 5 ]. A recent survey of Clinical Trials Units (CTUs) in the United Kingdom conducted by the some of the authors [ 6 ] found that recruitment remained the number one priority of those units.

A recent review outlined three core areas of relevance in improving recruitment and retention: infrastructure (for example networks, resources, and information technology), professional and public engagement with research, and methodological innovation (the development of an evidence base around effective methods of recruitment) [ 7 ]. This current paper is designed to provide an overview of the current knowledge and practice in the area of methodological innovation, in order to set out a clear research agenda for the future.

Methodological innovation

Many insights into the recruitment and retention process have been generated from qualitative case studies conducted alongside existing trials [ 8 – 11 ], as well as research on hypothetical situations [ 12 , 13 ]. However, translating those insights into enduring and generalizable impacts on recruitment is not straightforward. Although this may be due to other limitations in the academic literature (such as the lack of robust theory to guide intervention development), the limited impact of this work may in part reflect the fact that these (essentially post hoc ) explanations of recruitment processes are rarely subjected to formal examination in prospective studies. From the perspective of the principal investigator struggling with recruitment problems, this research has generated hypotheses to be tested rather than proven levers to ease recruitment.

The most robust test of the effectiveness of a recruitment or retention method is a trial comparing one recruitment method with an alternative, ‘nested’ within an ongoing trial being conducted in routine settings. By ‘nesting’, we refer to patients being randomly allocated to two or more alternative methods of recruitment. For example, a published study randomly allocated patients to an opt-in (where they were asked to actively signal willingness to participate in research) or opt-out method (where they were contacted repeatedly unless they stated unwillingness to participate) [ 14 ]. Such studies allow a less biased and more externally valid assessment of the effectiveness of a recruitment intervention. Nevertheless, despite the vast amount of activity in the area of clinical trials, nested studies of recruitment interventions remain very rare [ 15 – 17 ].

In this paper, we draw on a number of sources of data (including existing reviews on recruitment and retention interventions, survey data from CTUs in the United Kingdom, and views of participants in a recruitment workshop) to meet the following aims: to summarize knowledge about interventions to improve recruitment and retention, to indicate the range of interventions used by CTUs in the United Kingdom, to present a priority list of recruitment and retention interventions for evaluation, and to consider wider issues concerning the testing of recruitment interventions.

Summary of current knowledge on recruitment and retention

Interventions to improve recruitment have been the focus of a number of systematic reviews. A Cochrane review collated randomized and quasi-randomized controlled trials of interventions to increase recruitment to trials, including those recruiting to hypothetical studies [ 15 , 16 ]. The review included 45 trials involving 46 interventions and over 43,000 participants. Some interventions were effective in increasing recruitment, such as telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84), and open designs whereby participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36). A substantial problem noted by the reviewers was the tendency for investigators to evaluate new interventions that are unlike earlier interventions, making pooling data difficult. This has resulted in a large pool of relatively unique recruitment interventions of uncertain benefit. Other reviews [ 18 , 19 ] came to similar conclusions, although one review found no evidence that strategies aiming to increase understanding of the trial process improved recruitment, but did find some support for strategies that increased understanding of the health problem being studied [ 18 ].

Fletcher et al . [ 20 ] focused on strategies aimed at increasing the recruitment activity of clinicians and found eight quantitative studies, only three of which were trials. One trial looked at the effect of using nurses rather than surgeons to recruit participants and found that this had little or no effect (RR 0.94, 95% CI 0.76 to 1.17), though it was more cost-effective. There was limited evidence that greater communication between central trial coordinators and trial sites, and on-site monitoring had no impact on recruitment. The use of qualitative methods to identify and overcome barriers to clinician recruitment activity appeared promising, although the picture was mixed, with impressive improvements at one centre and no or modest improvements at others. The approach is certainly worthy of further investigation. A Cochrane review of incentives and disincentives to participation in trials by clinicians found no trials of relevant interventions [ 21 ]. The impact of a number of potential (dis)incentives was explored in observational studies but none were shown to have a significant impact. The authors suggested that in the absence of robust evidence, researchers need to be aware that many aspects of trial design and conduct might affect clinicians’ willingness to invite patients to participate.

In summary, there are some promising strategies for increasing recruitment to trials. However, some of those methods (such as open-trial designs and opt-out strategies), must be considered carefully as their use may also present methodological or ethical challenges. Use of qualitative methods to explicitly identify and address barriers to participation appears promising and warrants greater evaluation. There is a clear knowledge gap with regard to effective strategies aimed at recruiters.

Retention strategies have been the subject of three systematic reviews. Most of the retention strategies evaluated have focused on improving response to postal or electronic questionnaires, rather than return to trial sites to complete face-to-face assessments. A Cochrane systematic review on methods to increase response to postal and electronic questionnaires included 513 trials, with 137 strategies identified [ 22 ]. The most effective strategies to improve postal questionnaire response were: monetary incentives (odds ratio (OR) 1.87, 95% CI 1.73 to 2.04), recorded delivery (OR 1.76, 95% CI 1.43 to 2.18), a teaser on the envelope (OR 3.08, 95% CI 1.27 to 7.44) and having a more interesting questionnaire topic (OR 2.00, 95% CI 1.32 to 3.04). Other communication and questionnaire modification strategies found to be effective were: including pre-notification reminders, follow-up contact with participants, shorter questionnaires, and providing a second copy of a questionnaire. Several effective strategies for increasing responses to electronic questionnaires were found which included: including a picture in an email (OR 3.05, 95% CI 1.84 to 5.06), non-monetary incentives (OR 1.72, 95% CI 1.09 to 2.72) and other communication, and motivational and electronic questionnaire strategies. However, mentioning ‘Survey’ in the email subject line (OR 0.81, 95% CI 0.67 to 0.97), and emails including a male signature (OR 0.55, 95% CI 0.38 to 0.80) reduced the odds of a response. An earlier systematic review also focused on ways to increase the response to postal questionnaires in healthcare research [ 23 ]. A total of 15 trials were included in this review. Reminder letters (OR 3.7, 95% CI 2.30–5.97) and shorter questionnaires increased response (OR 1.4, 95% CI 1.19 to 1.54). Monetary incentives were not found to be effective.

These reviews were broad and included nested evaluations of strategies to improve retention in surveys, cohort studies, and randomized trials. Although some of the included trials in the reviews were nested in trials, most were nested in other study designs and the results may not be directly applicable to trials. A recent systematic review examined the effectiveness of strategies to improve retention in randomized trials specifically, and found 38 trials that evaluated six different types of strategies [ 17 ]. Most of the included trials aimed to improve questionnaire response. Questionnaire response was improved by actually adding monetary incentives (RR =1.18, 95% CI 1.09 to 1.28), the offer of monetary incentives (RR =1.25, 95% CI 1.14 to 1.38), and higher value incentives (RR =1.12, 95% CI 1.04 to 1.22). Based on results of single trials, response was improved by recorded delivery of questionnaires (RR =2.08, 95% CI 1.11 to 3.87), a specialized postal strategy (RR =1.43, 95% CI 1.22 to 1.67) and an open-trial design (RR =1.37, 95% CI 1.16 to 1.63). There is no clear evidence that questionnaire response or retention were improved by any of the other incentives, questionnaire modification, and communication strategies evaluated including the giving or offering gifts, offering charity donations, shorter or longer and clear questionnaires, sending questionnaires early, ‘enhanced’ letters (i.e. letters which contained additional information about trial processes or which included novel features, such as the signature of the main investigator), priority post, additional reminders, questionnaire question order, reminders to sites, and behavioral or case management strategies.

In summary, offering and giving small monetary incentives improves questionnaire response in randomized trials, while non-monetary incentives and some communication strategies have shown no effect. Some strategies need further evaluation, particularly where the results are based on single trials.

In the United Kingdom, funding bodies increasingly require that trials involve a United Kingdom Clinical Research Collaboration registered CTU to ensure high quality delivery and appropriate support with ethical, governance, operational, and methodological issues. Due to their active involvement with multiple trials, CTU staff are potentially in an excellent position to provide an overview of current methods used to stimulate recruitment and retention.

In order to provide data on current practice, 48 CTU directors in the United Kingdom were sent an invitation to an online survey about the methods and practices currently used by CTUs to improve recruitment and retention. Directors were asked to identify a member of staff best placed to provide responses on behalf of the unit. Where more than one member of staff from the same CTU completed the survey, similar responses were combined to ensure that responses from the same CTU were not counted twice. Respondents were asked about the methods used to improve recruitment and retention (with or without formal evaluation), methods which had been formally evaluated, and recruitment and retention interventions thought to merit evaluation in the future. The full list of questions is provided in Additional file 1 . Two reminder emails were distributed to encourage responses from all CTUs.

The results from the CTUs survey were used to inform a workshop on interventions to improve recruitment and retention, organized by the Medical Research Council North West Hub for Trials Methodology Research on behalf of the Medical Research Council Hub for Trials Methodology Research Network. Attendees at the workshop (n =45) were predominantly staff from CTUs (approximately 80%), as well as researchers outside CTUs, and representatives from funding agencies from the United Kingdom. Data from existing Cochrane reviews (summarized previously) were used alongside data from the survey to generate discussion around recruitment interventions. The final part of the workshop was used to generate further priorities for evaluation. Participants were split into small groups and asked to reflect on the data from the survey and the reviews, and to develop a priority list of interventions that would potentially improve recruitment and could be subjected to empirical testing. Groups reported back at the end of their discussions on both the nature of those interventions and their priority order, and the results were categorized by the workshop leader (PW). As the survey and workshop used professionals and involved discussions of current practice, no formal ethical approval or consent was deemed necessary.

Responses were received from 23 individuals representing 18 CTUs (38%). Respondents included statisticians, trials managers, health researchers, and research nurses.

Current recruitment and retention interventions

Table  1 shows the methods routinely used to encourage recruitment and retention, which were coded into the following categories: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. These broadly map onto the categories of recruitment interventions found in the recent Cochrane review discussed previously [ 15 ].

Patient contact interventions in recruitment related to appropriateness of the materials and the range of ways of getting information to patients, whereas retention was more focused on the number of contacts with patients. Both recruitment and retention interventions highlighted ways of reducing burden on patients, although it is not clear that research burden is necessarily the main barrier to participation. A large number of systems and monitoring interventions were discussed, to expand the range of methods used to identify patients, and to enable participants to be identified in the longer term as the trial progresses. Incentives included a wide range of potential interventions, such as direct payment for recruiters, patient expenses and gifts, and secondary incentives such as authorship on papers for staff involved in recruitment. Design issues were most often discussed in relation to recruitment, and included initial appropriateness of the design, the importance of pilot and feasibility studies, as well as flexibility in response to difficulties of recruitment. Respondents highlighted the importance of relationships in both recruitment (with the focus on relationships between the research team and recruitment staff) and retention (in terms of building and maintaining relationships with patients).

Table  2 describes interventions felt to merit investigation by respondents, in three categories: training site staff, communication with patients, and incentives. Some of these areas have been assessed in existing reviews, for example, site visits and intensive communication have been the subject of two studies with a published review, with little demonstrable effect on recruitment [ 20 ]. It is noteworthy that the impact of patient and public involvement was raised in two themes, given recent observational research suggesting an association between patient involvement and recruitment success [ 24 ]. Although the use of patient and public involvement is likely to be too embedded in current research to test its impact compared with an absence of involvement, exploring the relative benefits of different types of patient involvement, or different levels of resourcing of involvement is still likely to be of benefit to the research community.

Priorities for evaluation - results from the workshop

The results from the CTUs survey were used to inform a workshop on interventions to improve recruitment and retention, using small group work to generate further priorities for evaluation. Table  3 details the results of the small group work. The top priority identified was training for site staff, followed by different methods of communication with patients. The following sections provide more information about the potential priorities within those areas that were generated at the workshop and through follow-up teleconferences among workshop participants.

Training site staff

Many trials involve direct communication between patients and recruitment staff, and there is variability in the ability of staff on the same trial to achieve high levels of recruitment, with some studies reporting high levels of recruitment from a minority of practitioners [ 25 ]. This may reflect factors other than differences in their patient populations, such as variation among staff in the perceived importance of the study question, or different attitudes to equipoise. Identification of the characteristics of staff associated with recruitment and retention success could lead to a better selection of staff, while comparison of staff with different levels of recruitment success within the same trial might provide insights into effective components of training which could be developed into relevant training packages prior to formal evaluation. Such development will need to take into account the current debates concerning the ethics around coercive communication [ 26 , 27 ]. There is also an interesting empirical question concerning the relationship between strategies that enhance recruitment, and effects on retention, as there is the possibility that encouraging ambivalent patients into studies may lead to short-term gains in recruitment, and longer term challenges in retention. The need to evaluate different models of verbal communication (for example empathic communication versus information provision) and to gain evidence of whether changes to recruiter communication behaviour leads to benefits for patients beyond recruitment rates (for example, improved satisfaction with the recruitment process and perceptions of shared decision-making) were also identified. Emphasis was placed on understanding patient priorities at the time of recruitment and how these may change over time to aid retention [ 28 ].

The relevant impact of generic communication skills versus specific skills around particular issues is an important issue. For example, discussions around patient preferences are known to be a major potential barrier to trial participation [ 29 ] and specific training in managing those discussions might be more fruitful than generic interventions, especially in certain contexts where preferences are particularly important [ 28 ]. However, studies continue to show problems in the core aspects of communication [ 30 ]. Another important issue is whether training should be provided at the start of any trial, for all recruiters, or whether it is more feasible and efficient to identify staff with low recruitment rates and intervene later, potentially following detailed qualitative work to identify the precise nature of the problems [ 31 , 32 ].

Methods of communication with patients

As noted, the focus of much of the discussion around training site staff was around the issue of face-to-face communication, whereas this theme related more to different types and platforms for communication with patients, and the balance between face-to-face discussions, other forms of providing information to patients [ 33 ], and wider interventions related to shared decision-making [ 34 ]. The use of technology for communication was highlighted in particular for recruitment in trials where the initial recruitment is not via a face-to-face consultation (such as community-based trials among patients with existing conditions recruited initially by postal or other methods). Technology was also considered to be an area that could assist with the retention of participants over time, both through effective tracking of patients and methods used to enhance motivation to continue participation (such as reminders and updates about trial progress).

Given the dissatisfaction among patients and staff over the potential length and burden associated with standard patient information sheets, technology would also potentially provide flexible and patient-centered methods to provide information in appropriate depth according to patient preference (as long as it meets minimum criteria as set by ethical and regulatory bodies) [ 35 ].

As noted in Tables  1 and 2 , a wide range of potential interventions acting as incentives are in use and of interest to staff currently involved in the recruitment to trials, but the evidence base is limited [ 10 , 21 ]. In relation to patients, this may include payment for time taken to participate (which might not be viewed formally as an incentive, although it might have motivational benefits), small gifts and payment for incidental expenses, as well as formal cash or voucher incentives for participation and retention. However, the scope for testing such incentives through formal experimental methods may be limited by ethical and equity considerations.

Issues of incentives can also be applied to professionals, although the scope here may be greater, as potential incentives could be indirect (such as authorship on papers). There may also be greater potential for experimental work in the testing of the comparative effectiveness of schemes which provide differential incentives for different recruitment staff, teams, or sites depending on their relative performance (per patient recruited incentives versus block payments for meeting targets).

What is needed to facilitate rapid testing and development of interventions?

Although there was agreement about the need to conduct research on recruitment, the actual number of recruitment interventions nested within existing trials is very small [ 15 ]. Research has highlighted some of the known barriers to undertaking such research [ 36 ] such as increases in complexity, compatibility between the host trial where the recruitment research is done and nested trials (for example, the relevance of certain recruitment interventions to certain patient populations), the impact of nesting interventions on relationships with collaborators, as well as issues of preferences among research staff (and resulting lack of equipoise), and concerns about appropriate sample size.

Data on these issues were also collected from the CTUs survey, and the results generally fell into three categories. The first related to the logistics of running nested studies, in terms of the extra resources required, additional complications that might be caused to the delivery of the host trial (such as regulatory delays), and ethical barriers. The second barrier was a lack of perceived equipoise around many proposed recruitment processes and lack of enthusiasm in subjecting them to formal testing. The third category related to scientific issues, including concerns about the power to detect what might be quite small effects from methodological innovations, and the likely impact of variation in the effects of recruitment interventions, in terms of their effects on different sites, in different trials, and at different times.

Limitations of the study

The CTUs survey was limited by the 38% response rate, and it is possible that non-responding units manage recruitment and retention differently from those included in the survey. Workshop participants (academics and staff in CTUs) represent key stakeholders, but the views of those attending a workshop on recruitment and retention may not have been representative of the wider trials community, and the findings would need confirmation in other contexts. Importantly, different priorities may be identified by other stakeholder groups, and in different countries. Particularly, there is a need to replicate these findings with patients and carers as core stakeholders in recruitment and retention. In this study, the CTUs survey was used to develop a list of recruitment interventions to feed into discussions in the workshop, but the content generated by the survey and the priorities generated by the workshop were not formally triangulated in any way.

What are the limits to the impact of recruitment and retention interventions?

As noted previously, a recent review outlined three core areas of relevance to improving recruitment and retention: infrastructure, stakeholder engagement with research, and methodological innovation. In this paper, we have focused on methodological innovation, which we believe has an important part to play in improving recruitment and retention performance, and has the advantage being able to be evaluated and implemented throughout the platform of current clinical trials in a rigorous and controlled manner. Although the results are limited somewhat by the low response rate and the potential for bias, they do give a unique indication of the views of CTUs currently involved in recruitment and retention.

However, it is unclear how much variance in recruitment and retention performance is due to technical issues amenable to methodological research, compared to other issues such as available infrastructure, the organization, leadership, management and culture of research teams, and attitudes and values within the wider community. For example, staff in primary care networks in another workshop identified ‘positive attitudes of primary care staff towards research’ and ‘trust of researchers by potential participants’ as key contextual factors [ 37 ]. These factors are not necessarily those that are the most amenable to empirical testing, especially in a formal randomized comparison, although there are relevant examples [ 38 ].

It is noteworthy that many of the issues felt by our respondents to be worthy of evaluation are likely to have relatively modest effects on recruitment or retention, although this may reflect the fact that suggestions for interventions of higher impact (such as incentives) may be viewed as of low feasibility because of regulatory and ethical barriers. The scientific benefits of modest impacts on recruitment may be small (an increase in recruitment rates from 10 to 15% may have little substantive effect on external validity), although the benefits in terms of logistics, time taken to recruit, and trial funding may still be significant, given that the recruitment period may be a key driver of the length of a trial and its overall cost. Smaller benefits may be more important in retention.

It is possible that issues of efficiency are equally important. For example, rather than adopting methods with the aim of increasing the proportion of eligible patients who participate, studies may focus on whether more efficient methods can be adopted to maximize the number of patients who can be approached (although this is of course less relevant in certain contexts, such as rarer diseases). For example, in primary care, many trials have adopted postal recruitment using existing disease registers in preference to traditional recruitment led by clinicians [ 39 ]. The proportion of patients recruited by such postal methods may be equal to or less than traditional methods, but allows recruitment over a wider geographical area whilst using the same resources.

A research agenda for recruitment and retention interventions

The results of this survey and workshop raise a number of implications for a future research agenda in this area. Experienced trial staff may have implicit ideas about what works in recruitment and retention, and a wide variety of factors are thought to be relevant. Some of these are likely to reflect good research practice and may not need or warrant empirical testing. However, given the importance of recruitment and the disruption it can cause, there is a surprisingly limited consensus on what needs to be tested to make recruitment practices more evidence-based. Authors of systematic reviews have commented that interventions that do get tested often bear an uncertain relationship to those in the broader literature, making pooled analyses difficult. We have highlighted three core areas that were felt to be a suitable focus for future work, and have considered some of the issues that might be amenable to testing. Further advances in this area may well be facilitated by the development and adoption of frameworks and typologies of recruitment methods of the type that have been adopted in other areas exploring complex, behavioral interventions [ 40 ]. This would involve describing categories of interventions and their potential mechanisms of effect, as well as potential moderating factors, such as the impact of different patient and trial characteristics. As well as providing benefits in terms of the development of effective interventions, this would allow more effective pooling of analyses at the synthesis stage.

Experienced trials personnel such as those involved in the surveys and workshops may be used to dealing with a lack of equipoise among clinical staff [ 41 ]. Therefore, it is noteworthy that there is not always equipoise among such staff about the effects of recruitment interventions, which can potentially act as a barrier to their evaluation. This raises the issue of how the delivery of nested recruitment interventions can be better incentivized. For example, individual trial teams and CTUs might receive additional resources to support their attempts to nest recruitment and retention studies in their trials to increase the adoption of this approach.

Scientific objections to evaluations of recruitment and retention interventions around issues such as power and heterogeneity are reasonable, although effective categorization, pooling, and meta-analysis could allow for the testing and consideration of many of these issues. The Medical Research Council Systematic Techniques for Assisting Recruitment to Trials (MRC START) program [ 42 ] and related initiatives such as Studies Within A Trial (SWAT) [ 43 ] and TrialsForge [ 44 ] may encourage a common framework across recruitment interventions and pooling to provide a more precise estimate of their effects, and to explore variation in their effects across patient populations, trial types, and recruitment contexts.

Significant resources continue to be invested into clinical trials, but recruitment and retention continue to be problematic and remain high priorities among CTUs in the United Kingdom. There continues to be a major gap in the evidence base regarding what works in recruitment and retention. These findings provide guidance on areas that may be prioritized in the funding of further methodological research in this important area.

Abbreviations

95% confidence interval

Clinical Trials Unit

Odds ratio, RR: risk ratio.

Department of Health: Best Research for Best Health - A New National Health Research Strategy. 2006, London: Department of Health

Google Scholar  

McDonald A, Knight R, Campbell M, Entwistle V, Grant A, Cook J, Elbourne D, Francis D, Garcia J, Roberts I, McDonald A, Knight R, Campbell M, Entwistle V, Grant A, Cook J, Elbourne D, Francis D, Garcia J, Roberts I, Snowdon C: What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006, 7: 9-10.1186/1745-6215-7-9.

Article   PubMed   PubMed Central   Google Scholar  

Bower P, Wilson S, Mathers N: How often do UK primary care trials face recruitment delays?. Fam Pract. 2007, 24: 601-603. 10.1093/fampra/cmm051.

Article   PubMed   Google Scholar  

Darbyshire J: The UK Clinical Research Network - building a world-class infrastructure for clinical research. Rheumatology. 2008, 47: 745-10.1093/rheumatology/ken112.

Article   CAS   PubMed   Google Scholar  

Sully B, Julious S, Nicholl J: A reinvestigation of recruitment to randomized, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013, 14: 166-10.1186/1745-6215-14-166.

Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson PR: The Trials Methodological Research Agenda: Results from a priority setting exercise. Trials. 2014, 15: 32-10.1186/1745-6215-15-32. doi:10.1186/1745-6215-15-32

Bower P, Wallace P, Ward E, Graffy J, Miller J, Delaney B, Kinmonth A: Improving recruitment to health research in primary care. Fam Pract. 2009, 26: 391-397. 10.1093/fampra/cmp037.

Bell-Syer S, Klaber-Moffett J: Recruiting patients to randomized trials in primary care: principles and case study. Fam Pract. 2000, 17: 187-191. 10.1093/fampra/17.2.187.

Mason V, Shaw A, Wiles N, Mulligan J, Peters T, Sharp D, Lewis G: GPs’ experience of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract. 2007, 24: 518-525. 10.1093/fampra/cmm047.

Raftery J, Bryant J, Powell J, Kerr C, Hawker S: Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Health Technol Assess. 2008, 12: 1-128.

McCann S, Campbell M, Entwistle V: Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. J Health Serv Res Policy. 2013, 18: 233-241. 10.1177/1355819613483126.

Llewellyn-Thomas H, McGreal M, Thiel E: Cancer patients decision making and trial-entry preferences: the effects of framing information about short-term toxicity and long-term survival. Med Decis Making. 2010, 15: 4-12.

Article   Google Scholar  

Leathem C, Cupples M, Byrne M, O’Malley M, Houlihan A, Murphy A, Smith S: Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomized controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care. BMC Med Res Methodol. 2009, 19: 40-

Junghans C, Feder G, Hemingway H, Timmis A, Jones M: Recruiting patients to medical research: double blind randomized trial of “opt-in” versus “opt-out” strategies. BMJ. 2005, 331: 940-10.1136/bmj.38583.625613.AE.

Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P: Strategies to improve recruitment to randomized controlled trials. Cochrane Database Syst Rev. 2010, ᅟ: ᅟ-MR000013

Treweek S, Lockhart P, PitKethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila T, Sullivan F, Wilson S, Jackson C, Jones R, Mitchell ED: Methods to improve recruitment to randomized controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013, 3: e002360-

Brueton V, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G: Strategies to improve retention in randomized trials. Cochrane Database Syst Rev. 2013, ᅟ: ᅟ-MR000032

Caldwell P, Hamilton S, Tan A, Craig J: Strategies for increasing recruitment to randomized controlled trials: systematic review. PLoS Med. 2010, 7: e1000368-10.1371/journal.pmed.1000368.

Watson J, Torgerson D: Increasing recruitment to randomized trials: a review of randomized controlled trials. BMC Med Res Methodol. 2006, 6: 34-10.1186/1471-2288-6-34.

Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S: Improving the recruitment activity of clinicians in randomized controlled trials: a systematic review. BMJ Open. 2012, 2: e000496-

Rendell J, Merritt R, Geddes J: Incentives and disincentives to participation by clinicians in randomized controlled trials. Cochrane Database Syst Rev. 2007, ᅟ: ᅟ-MR000021

Edwards P, Roberts I, Clarke M, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix L, Pratap S: Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009, ᅟ: ᅟ-MR000008

Nakash R, Hutton J, Jørstad-Stein E, Gates S, Lamb S: Maximising response to postal questionnaires – a systematic review of randomized trials in health research. BMC Med Res Methodol. 2006, 6: 5-10.1186/1471-2288-6-5.

Ennis L, Wykes T: Impact of patient involvement in mental health research: longitudinal study. Br J Psychiatry. 2013, 203: 381-386. 10.1192/bjp.bp.112.119818.

King M, Sibbald B, Ward E, Bower P, Lloyd M, Gabbay M, Byford S: Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy and usual general practitioner care in the management of depression as well as mixed anxiety and depression in primary care. Health Technol Assess. 2000, 4: 1-83.

CAS   PubMed   Google Scholar  

Shilling V, Williamson P, Hickey H, Sowden E, Smyth R, Young B: Processes in recruitment to randomized controlled trials of medicines for children (RECRUIT): a qualitative study. Health Technol Assess. 2011, 15: 1-116.

Gillies K, Entwistle V: Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision. J Med Ethics. 2012, 38: 751-756. 10.1136/medethics-2011-100059.

Mills N, Donovan J, Wade J, Hamdy F, Neal D, Lane J: Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol. 2011, 64: 1127-1136. 10.1016/j.jclinepi.2010.12.017.

Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F: Improving design and conduct of randomized trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002, 325: 766-770. 10.1136/bmj.325.7367.766.

Moynihan C, Lewis R, Hall E, Jones E, Birtle A, Huddart R, SPARE Trial Management Group: The Patient Deficit Model Overturned: a qualitative study of patients’ perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011). Trials. 2012, 13: 228-10.1186/1745-6215-13-228.

Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan J: Key issues in recruitment to randomized controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011, 12: 78-10.1186/1745-6215-12-78.

Donovan J, Lane A, Peters T, Brindle L, Saltera E, Gillatt D, Powell P, Bollinae P, Neal D, Hamdy F, ProtecT Study group: Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol. 2009, 62: 29-36. 10.1016/j.jclinepi.2008.02.010.

Shneerson C, Windle R, Cox K: Innovating information-delivery for potential clinical trials participants. What do patients want from multi-media resources?. Pat Educ Couns. 2013, 90: 111-117. 10.1016/j.pec.2012.06.031.

Gillies K, Skea Z, Politi M, Brehaut J: Decision support interventions for people making decisions about participation in clinical trials (Protocol). Cochrane Database Syst Rev. 2012, ᅟ: ᅟ-CD009736

Antonious E, Draper H, Reed K, Burls A, Southwood T, Zeegers M: An empirical study on the preferred size of the participant information sheet in research. J Med Ethics. 2011, 37: 557-562. 10.1136/jme.2010.041871.

Graffy J, Bower P, Ward E, Wallace P, Delaney B, Kinmonth A, Collier D, Miller J: Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials. BMC Med Res Methodol. 2010, 10: 38-10.1186/1471-2288-10-38.

Graffy J, Grant J, Boase S, Ward E, Wallace P, Miller J, Kinmonth A: UK research staff perspectives on improving recruitment and retention to primary care research; nominal group exercise. Fam Pract. 2009, 26: 48-55.

Tulsky J, Arnold R, Alexander S, Olson M, Jeffreys A, Rodriguez K, Skinner C, Farrell D, Abernethy A, Pollak K: Enhancing communication between oncologists and patients with a computer-based training program. Ann Intern Med. 2011, 155: 593-601. 10.7326/0003-4819-155-9-201111010-00007.

Richards D, Hughes-Morley A, Hayes R, Araya R, Barkham M, Bland J, Bower P, Cape J, Chew-Graham C, Gask L, Gilbody S, Green C, Kessler D, Lewis G, Lovell K, Manning C, Pilling S: Collaborative Depression Trial (CADET): multi-centre randomized controlled trial of collaborative care for depression - study protocol. BMC Health Serv Res. 2009, 9: 188-10.1186/1472-6963-9-188.

Michie S: Designing and implementing behaviour change interventions to improve population health. J Health Serv Res Policy. 2008, 13: 64-69. 10.1258/jhsrp.2008.008014.

Ziebland S, Featherstone K, Snowdon C, Barker K, Frost H, Fairbank J: Does it matter if clinicians recruiting for a trial don’t understand what the trial is really about? Qualitative study of surgeons’ experiences of participation in a pragmatic multi-centre RCT. Trials. 2007, 8: 4-10.1186/1745-6215-8-4.

Rick J, Bower P, Collier D, Eldridge S, Graffy J, Kennedy A, Knapp P, Hughes-Morley A, Salisbury C, Small N, Torgerson D, Treweek S, Wallace P: Systematic techniques for assisting recruitment to trials (START): developing the science of recruitment. Trials. 2013, 14 (Suppl 1): O61-10.1186/1745-6215-14-S1-O61.

Article   PubMed Central   Google Scholar  

Smith V, Clarke M, Devane D, Begley C, Shorter G, Maguire L: SWAT 1: what effects do site visits by the principal investigator have on recruitment in a multicentre randomized trial?. J Evid Base Med. 2014, 6: 136-137.

Treweek S: Trial forge: a systematic approach to making trials more efficient. Trials. 2013, 14 (Suppl 1): O121-10.1186/1745-6215-14-S1-O121.

Download references

Acknowledgements

The workshop was funded by a research project grant from the MRC Network of Hubs for Trials Methodology, R24. The survey was funded by the MRC North West Hub for Trials Methodology Research. The funders had no role in the design, collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.

Author information

Authors and affiliations.

National Institute for Health Research School for Primary Care Research, North West Hub for Trials Methodology Research, University of Manchester, Oxford Road, Manchester, M13 9PL, UK

Peter Bower

MRC Clinical Trials Unit at University College London, 125 Kingsway, London, WC2B 6NH, UK

Valerie Brueton

North West Hub for Trials Methodology Research, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool, L69 3GA, UK

Carrol Gamble

Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK

Shaun Treweek

North West Hub for Trials Methodology Research and Department of Biostatistics, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool, L69 3GA, UK

Catrin Tudur Smith & Paula Williamson

North West Hub for Trials Methodology Research and Department of Psychological Sciences, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool, L69 3GA, UK

Bridget Young

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Peter Bower .

Additional information

Competing interests.

The authors declare that they have no competing interests.

Authors’ contributions

PW and CTS conducted the CTU survey. PW conceived the idea for the workshop. PB, VB, CG, ST, CTS, BY, and PW contributed to the workshop. PB drafted the manuscript, with additional sections written by ST, VB, and CTS. PB, VB, CG, ST, CTS, BY, and PW gave final approval for the version to be published, and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors read and approved the final manuscript.

Electronic supplementary material

Additional file 1: clinical trials unit survey questions on recruitment and retention.(docx 15 kb), rights and permissions.

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated.

Reprints and permissions

About this article

Cite this article.

Bower, P., Brueton, V., Gamble, C. et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials 15 , 399 (2014). https://doi.org/10.1186/1745-6215-15-399

Download citation

Received : 03 January 2014

Accepted : 30 September 2014

Published : 16 October 2014

DOI : https://doi.org/10.1186/1745-6215-15-399

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

  • Recruitment

ISSN: 1745-6215

  • Submission enquiries: Access here and click Contact Us
  • General enquiries: [email protected]

clinical research recruitment techniques

U.S. flag

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

  • Publications
  • Account settings
  • Advanced Search
  • Journal List
  • BMC Med Res Methodol

Logo of bmcmrm

Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams

Lisa newington.

1 NIHR Biomedical Research Centre, Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, Guy’s Hospital, SE1 9RT, London, UK

Alison Metcalfe

2 Florence Nightingale School of Nursing and Midwifery, King’s College London, James Clark Maxwell Building, SE1 8WA London, UK

Recruiting the required number of participants is vital to the success of clinical research and yet many studies fail to achieve their expected recruitment rate. Increasing research participation is a key agenda within the NHS and elsewhere, but the optimal methods of improving recruitment to clinical research remain elusive. The aim of this study was to identify the factors that researchers perceive as influential in the recruitment of participants to clinically focused research.

Semi-structured interviews were conducted with 11 individuals from three clinical research teams based in London. Sampling was a combination of convenience and purposive. The interviews were audio recorded, transcribed verbatim and analysed using the framework method to identify key themes.

Four themes were identified as influential to recruitment: infrastructure, nature of the research, recruiter characteristics and participant characteristics. The main reason individuals participate in clinical research was believed to be altruism, while logistical issues were considered important for those who declined. Suggestions to improve recruitment included reducing participant burden, providing support for individuals who do not speak English, and forming collaborations with primary care to improve the identification of, and access to, potentially eligible participants.

Conclusions

Recruiting the target number of research participants was perceived as difficult, especially for clinical trials. New and diverse strategies to ensure that all potentially eligible patients are invited to participate may be beneficial and require further exploration in different settings. Establishing integrated clinical and academic teams with shared responsibilities for recruitment may also facilitate this process. Language barriers and long journey times were considered negative influences to recruitment; although more prominent, these issues are not unique to London and are likely to be important influences in other locations.

Participant recruitment is vital to the success of a research study, and yet many research projects fail to recruit a sufficient number of participants [ 1 ]. Increasing participation in clinical research has become a key area of focus within the NHS, with the aim of facilitating evidence-based policy, improving health outcomes and reducing health inequality [ 2 ]. The identification of optimal recruitment methods is gaining interest and a recent systematic review of strategies aimed at improving recruitment to randomised controlled trials (RCTs) identified 45 relevant studies and categorised six types of intervention: trial design, obtaining consent, approach to participants, financial incentives, training for recruiters and trial coordination [ 3 ]. Overall, the general strategies found to be effective in improving recruitment included: making telephone reminders to non-responders, having opt-out procedures where potential participants are required to contact the trial team if they do not want to be contacted about a trial, and having open rather than blinded trial designs [ 3 ]. It is not known whether more trialists are now adopting these strategies, or if they are proving successful in other settings or for other research methodologies.

Attempts to optimise recruitment and retention for non-interventional research studies include a range of techniques, such as using large sampling frames, sending reminders, running wide-scale publicity campaigns, providing free helplines and providing material in the respondents’ own languages [ 4 ]. While there may be universal elements to improving clinical research recruitment, reports of successful recruitment strategies for non-intervention studies are often directed at the particular target demographic group, for example: African American Elders [ 5 ], palliative care patients and their carers [ 6 ], adolescent mothers [ 7 ] and individuals from minority groups [ 8 ]. It is clear that recruitment and retention strategies need to be relevant to the target population and the research methodology used, and therefore the optimum strategy is likely to vary. However, further investigation of research recruitment according to different study designs is required to enable an evidence-based approach to recruitment.

The views of the researchers and clinicians involved in participant recruitment are beginning to be explored. We recently conducted a systematic review and thematic meta-synthesis to investigate this subject and found that the recruitment process could be defined by five key themes: building a research community, securing resources, the nature of the research, professional identities, and recruitment strategies [ 9 ]. Across all five themes there were reports of competition and compromise. Competition arose over funding, staffing and participants, and between clinical and research responsibilities; whilst compromise was needed to create study designs that were acceptable to patients, clinicians and researchers. Overall the views of researchers and clinicians were similar, which was partly explained by the overlapping elements of their roles.

The factors and situations that prompt some individuals to agree to participate in clinical research when others decline have also received attention, with the hope of informing new recruitment practices. However, to date, this work has been predominantly directed at a single medical condition and there have been varied findings [ 10 - 14 ].

Geographical location has been shown to influence recruitment rates to RCTs, with large cities such as London associated with poorer recruitment [ 15 , 16 ]. Possible suggestions for lower recruitment rates in London are the more varied ethnic population (individuals who are traditionally more difficult to engage in medical research), higher population mobility (individuals potentially missing invitations or reminders to participate), and more university hospitals (creating research fatigue as individuals are repeatedly approached to participate in research) [ 15 ]. Research teams in London therefore not only have to contend with the recruitment issues faced elsewhere, but may face an additional set of issues associated with their location.

The aim of the current study was to identify and understand the factors affecting recruitment to clinically focused research in London, UK, with the aim of mapping the existing strategies and informing new approaches. This study adds to existing work by exploring pertinent themes that arose across different clinical areas, study designs and researcher roles, providing a broad view of the factors that researchers consider important for the recruitment of clinical research participants. The following questions were explored:

1) What do researchers perceive to be the influential factors in recruiting participants to their clinically focused research?

2) What steps do research teams take to optimise recruitment to their studies?

3) What are researchers’ perceptions of why potential participants consent or decline to participate in their research?

4) Does being located in London create any additional issues with recruitment?

A convenience sample of three research leads involved in clinically focused research and based in teaching hospitals in South London were identified and invited to participate in a one-off interview to discuss their experiences and perceptions of recruiting participants for their studies. The phrase clinically focused research was defined as any medical research requiring an individual’s consent to participate, including donation of tissue samples, observational studies and RCTs, and the discussion was limited to recruiting adult patients able to give informed consent. The interviews were semi-structured and used non-directive, open-ended questions based on topics identified from preliminary discussions with clinical researchers and from the existing literature; the topic guide is listed in Table  1 . Each participant was asked to identify other members of their team with differing roles and responsibilities, and a purposive sample of these individuals was also invited to participate in the study. The same topic guide was used throughout and additional individuals were identified as necessary to ensure a broad mix of research professions were included, and to enable interviewing to continue until saturation was reached. All interviews were conducted face-to-face by the primary author in early 2013 at locations chosen by the participants. The interviews were audio recorded and transcribed verbatim.

Interview topic guide

The interview data was analysed using the framework method established by Ritchie and Spencer [ 17 ]. The framework matrix was developed using NVivo 10 software (QSR) and incorporated the interview topic guide, ideas from the existing literature and prominent themes identified from a preliminary review of the transcripts. The transcripts were coded line by line and additional themes were entered into the matrix where necessary. The matrix was populated with summarised data according to participant and theme, and used to identify common and divergent issues in answer to the study research questions.

Ethical approval

This study was approved by the King’s College London, College Research Ethics Committee (Reference PNM/12/13-106). All participants gave informed consent to be interviewed. All but one participant also consented to anonymous quotes from their interviews being used in the resulting reports and publications.

A total of 15 individuals were invited to participate in the study, of which 11 agreed to be interviewed. Participant demographics are shown in Table  2 . One speciality registrar declined to be interviewed, citing that his role was predominantly clinical not research-based, and three speciality registrars did not reply to their invitations. The mean interview duration was 28 minutes, ranging from 19 to 48 minutes.

Participant demographics

*Medical doctor receiving advanced training in a specialist area.

The information provided has been limited to preserve the anonymity of the interviewees and their teams.

Interviewees were involved in a range of studies, all outpatient-based and run as part of three research teams (A, B and C) in three tertiary care hospital sites in South London. Study designs included a first-in-man drug trial, longitudinal observational studies, laboratory studies requiring one-off anonymous tissue samples, genetics studies, trials of therapy interventions, and physiological studies. All research teams carried out research with patients and healthy volunteers, and most interviewees had volunteered themselves as study participants at some stage. With the exception of the two clinical research scientists and the clinical research associate, all participants were also involved in clinical activities as part of their role. When asked why they became involved in clinical research, all participants reported having an interest in research at an earlier point in their career and acting upon this for a variety of reasons including: an extension of a previous role, the desire for more control over their work, part of their current training, to learn more about evidence-based medicine, to do something worthwhile, to improve job satisfaction and to ensure more sociable working hours. All interviewees were educated to degree level, four had gained a PhD and two were working towards a PhD or MD. All participants acknowledged difficultly in recruiting research participants and mentioned particular strategies or modifications that were made to improve recruitment within their teams. The general perception of recruitment was that it is hard to recruit the desired numbers in the allocated time and that more often than not, extensions to the recruitment period are required.

Influential factors in the recruitment of participants

Numerous factors were identified by the interviewees as influential in the recruitment of research participants and these were categorised into four main themes: infrastructure, nature of the research, recruiter characteristics and participant characteristics.

Infrastructure

The need for access to potentially eligible participants was emphasised throughout. Collaboration between hospital clinicians, GPs and researchers were viewed as essential for the identification of eligible patients and to avoid clinician gatekeeping. All research teams had established systems to facilitate the identification of patients, but there was awareness that potentially eligible patients seen in other departments or hospitals were frequently inaccessible.

“There will be a lot of patients going to [smaller hospitals], who could be enrolled in studies, but they’re not available there. They are available here. If they knew that we were doing it, and there was a mechanism for moving those patients for the duration of the trial here, I would think everyone would be happy. But there isn’t” . (Consultant, team A)

One team had developed a strategy where local hospitals were encouraged to identify eligible patients and refer them to the participating site for the duration of the trial. Whilst this was seen as a positive step, it was also acknowledged that greater recognition for the referring sites, in terms of funding and co-authorship, would be required to improve uptake.

The preparatory work carried out by research teams was considered highly influential in the success of recruitment. Screening patient records, identifying eligible patients, preparing appropriate recruitment material and ensuring that the relevant clinicians and researchers were fully informed about the study, were all recommended. These tasks were primarily the responsibility of the research nurses and research associates.

“Here, we do look through the clinic list and, myself on the busiest days, will look at the past three clinic letters and see if they’re going to be suitable, or if they’re already on the study. We do recommend that’s the best way to find patients. And then we’d print the relevant paperwork and put that in the notes, so the doctors can see. So then they don’t even have to think about it, it’s just there. I think that works best. I would say that maybe about half of places do that, because they haven’t got time. They haven’t got time to do the prep” . (Clinical research associate, team A)

One suggestion to improve access to patients was the use of opt-out systems. This was mentioned with reference to patients being required to opt out of research teams contacting them about relevant research projects, but was also discussed with regard to opting in to the routine donation of anonymous tissue samples (surplus to requirements for clinical tests) for clinically focused research. Neither system was currently in place.

Issue with the regulations surrounding ethical approval and the content of participant information sheets were commonly discussed. The interviewees thought that the approval process was too slow, which created delays in starting recruitment and raised concerns that their departments would get overlooked for involvement in multi-centre studies in favour of sites with faster turnaround times.

“We certainly need to improve the speed with which we’re able to take a study from application through to actually being run. We are unbelievable slow. Unbelievable top heavy with regulation… It often means, locally, that we get bypassed in these programmes” . (Consultant, team A)

The interviewees were also concerned that the information required by ethics committees led to the participant information sheets becoming excessively long and detailed, and off-putting to patients. The researchers were aware of the conflict between ensuring patients had sufficient information about a study to make an informed decision about participation, and providing accessible study literature, however many interviewees believed that with the current format, patients did not actually read the information sheets provided, instead relying on verbal discussions to make a decision about participation.

“I get a few who will [read the patient information sheets], but nobody does. I would say 98% of people don’t read it. I do a summary of what is important to them” . (Specialty registrar, team C)

Several researchers suggested inviting patients and members of the public to sit on ethics committees to provide feedback on this issue and one research team had implemented a strategy to use more images and pictures in their participant information sheets to improve readability.

Increasing public awareness of clinically focused research was widely thought to have the potential to improve research recruitment, with the exception of one interviewee who felt that people would only be interested in research when their health was affected. Whilst there were many comments on the need to increase awareness of research within hospitals and other healthcare facilities, interviewees had few suggestions of how this could be improved. There was frustration at the lack of media coverage or celebrity endorsement within their clinical areas, compared to the numerous high-profile campaigns for areas such as cancer research. However, the media was viewed as having both positive and negative effects on recruitment, depending on the nature of the coverage.

Nature of the research

The influence of the type of research on participant recruitment was discussed by all interviewees. It was noted that clinical trials were harder to recruit for than observational studies because they require greater commitment from the participants in terms of time and risk. The interviewees also acknowledged the difficulty between designing studies that were appealing to potential participants and ensuring they were scientifically robust.

“We wanted it to be a good trial from the beginning. So it wasn’t just ‘everybody gets [the intervention] and let’s see what happens’. Although that would have been much easier and might have given us the answer quicker. So it’s placebo controlled, randomised, double blind. Not only are we asking these people to possibly risk their lives, but they might not get it anyway” . (Clinical research scientist, team B)

Some studies incorporated open label or crossover phases after the initial RCT, which was believed to make the study more acceptable to patients. Other recommendations, such as allowing patients to have their study blood tests carried out in the community and offering evening and weekend research appointments, were suggested to reduce the time burden of research participation, but these strategies had not been adopted.

“I guess the big thing would be to try and reduce the burden of commitment to patients, as much as possible. If there was any chance that they could have research bloods taken with GPs, or in their local community, or research nurses could go and take the blood in their home, to avoid this” . (Research nurse, team A)

Payment for research participation was also discussed. Research leads highlighted the ethical issues associated with paying patients for research participation, whilst others acknowledged the role of payment as a driver in recruiting people to participate in their work. The semantics of this issue were important, with one interviewee stating that while it was unethical to pay patients to participate in research, there was the need to explore “being able to financially help volunteers better” . (Consultant, team A).

Recruiter characteristics

It was widely reported that patients were more likely to agree to participate research if they were asked by a medical doctor, specifically their usual doctor. Even for observational studies, which do not require a doctor to take consent, it was noted that recruitment was more successful if the doctor mentioned the study to the patient before the research nurse provided a more detailed explanation. In this respect, successful recruitment was seen as a team effort.

“Our clinicians are so pro-research they are very good at introducing it into the clinical consultation, which really helps, because if it’s first mentioned, I think, by a clinician it’s considered just a normal part of the clinical care, then I think people are sometimes a bit more accepting of it” . (Research nurse, team A)

In addition to the recruiters’ professional roles, their personality and knowledge of the research project were also considered influential. Although all interviewees had undergone the relevant research and ethics training, none had received specific training in recruitment. There was debate on whether it was possible to teach the art of recruitment and if so whether this would be useful. The more experienced researchers felt that specific training was unnecessary as recruitment style and strategy vary depending on the clinical speciality and the particular study involved, and on-the-job experience was believed to be more important that generic recruitment training. It was also suggested that an individual’s personality was central to their recruitment success, an aspect that is difficult to teach.

“ The art of getting people in; it’s not clear. If I couldn’t recruit to trials, I wouldn’t be doing trials… some of my colleagues are good at recruiting, some aren’t quite so good. Trying to tell someone what to do is just not helpful, is it? ” (Consultant, team B)

“Then it’s also your personality. I think patients, they need to trust you. If you are a little bit unsure about something – not about the protocol itself, because that changes and you can’t expect to know a thousand pages of protocol – but that you are confident. Holding their hands all they way during the study” . (Research nurse, team B)

The less experienced researchers believed they would have benefited from additional support during the early stages to learn how to optimise their recruitment success, but acknowledged that a general training programme was unlikely to be appropriate for all recruitment situations.

Interviewer: “Did anyone talk to you about recruiting?”

Respondent: “No, but it would have been helpful… No-one spoke to me and gave me any advice… Although studies are so different and patient groups are so different, that it’s probably slightly different for everyone” . (Specialty registrar, team A)

The clinical research scientists expressed frustration at being reliant on clinicians to recruit patients for their research, especially as they had completed the prerequisite training and had recruited patients previously; however current regulations prohibit non-clinicians from recruiting patients.

“I don’t know why they don’t think [scientists] can consent people here. We used to be able to. It’s only the last few years that we’ve not been able to. We’ve done all the consent courses and everything” . (Clinical research scientist, team B)

Participant characteristics

All interviewees thought that certain patients were more likely to agree to participate in clinically focused research than others. The reported reasons for this are explored in more detail in the section “Why do some individuals consent to participate and others decline?”, however it is important to highlight that for a potential participant to either consent or decline to participate in research, they must first be invited. This links to the previous issues of identifying and accessing eligible patients, but also relates to situations where potentially eligible patients may be denied the opportunity to take part. For example, several interviewees mentioned that individuals who do not speak or understand English are unable to participate in the majority of studies due to the absence of funding for interpreter and translation services.

“…that’s actually something we really need to think of as a team going forward with recruitment, because at the moment we’ve said, for example, if patients come with interpreters or they have no English, then we haven’t included them” . (Research nurse, team A)

One interviewee recalled using interpretation services in the past, but only as a last resort due to the additional workload created.

“It did happen in the past, that for some protocol it had been waived that you can have an interpreter, which can’t be a relative. Because it needs to be an independent interpreter. It needs to be really last chance, because it’s a lot of work, extra, on top of what you have to do” . (Research nurse, team B)

Where potential participants did speak sufficient English to be eligible for participation, but it was not their first language, some interviewees reported lower recruitment rates compared with native English speakers. Suggested reasons for this included communication issues or a general increased reluctance to participate in clinical research.

“Potentially there have been times in the past where I’ve felt that this person’s not really taking in what I’m saying, for various reasons, whether that’s to do with language differences, English not as a first language” . (Research nurse, team A)

Steps taken to optimise recruitment

Table  3 shows the recruitment strategies and specific techniques employed by the research teams and the interviewees’ suggestions of techniques to further improve recruitment. The recruitment strategies were divided into three main themes: preparation and planning, engendering patient support, and collaboration with clinicians. The majority of suggestions to improve recruitment were targeted at making research participation more appealing and less time consuming for patients.

Steps taken by research teams to optimise recruitment and interviewees’ suggestions for improvement

Why do some individuals consent to participate and others decline?

The interviewees believed that the main reason why patients agreed to participate in their research was altruism, including the desire to help future patients and the wish to give something back to the hospital and team that cared for them. For the latter, researchers were clear to point out their duty to ensure that research participation was truly voluntary, rather than an obligation.

“A common thing tends to be ‘you’ve done so much for me, I’m quite happy to do anything for you’. Which is a sort of double edged sword actually, because that’s very generous of them, but actually you want them to participate because they want to, and you have to say ‘well you don’t have to’, and you’ve got to think that they’ve actually understood” . (Research nurse, team A)

There was also a general consensus that many individuals who took part in clinically focused research valued the potential benefits of participation, namely the opportunity to access additional health checks, novel treatments, increased contact with clinicians and the clearly defined plan of care. For researchers who provided payment for participation in their studies, financial gain was also viewed as an important motivator.

“Some of the studies that we run here, we pay £50 a visit. So it’s also to do with people need a bit of extra cash at the moment” . (Research nurse, team C)

Furthermore, patients who were interested in the research question and believed that clinical research was worthwhile were considered more likely to accept the invitation to participate. As discussed previously, the nature of the research was also viewed as highly influential, with patients preferring to participate in non-interventional studies.

“I think it’s much easier to recruit for an observational study. Because we’re not doing anything that could harm them” . (Specialty registrar, team A)

No particular strategies were employed to recruit patients of different ethnicities or socio-demographic backgrounds, with the common belief that recruiters attempt to invite all eligible patients to participate, regardless of their background. Despite the fact that recruitment was limited to English language speakers, most researchers felt that they recruited a good spread of the local population, although this did depend on the clinical area under investigation and the time commitment involved.

“I suppose retired patients have probably said ‘yes’ more willingly. For our study, we are requiring them to have extra tests. Some of the patients have said they are worried about time. Or getting here from work earlier” . (Specialty registrar, team A)

For patients who declined to participate in clinical research, the predominant reasons were thought to be practical. Patients who were working were unable to take extra time off work for research appointments and the additional travel required to attend the hospital was also believed to be off-putting, especially for patients who did not live locally.

“I think for some, mainly it’s time I’d say. Because often they’ve been sat in the waiting room for up to an hour already. So when it gets to the point where they’ve had their appointment, they’ve been seen by a nurse… they’re just like ‘I’ve just not got time’. I think that’s the main issue” . (Clinical research associate, team A)

Fear was also considered important, mainly with respect to clinical trials. Fear of taking new drugs, fear of additional diagnoses being discovered from extra screening, fear of needles, fear of symptoms worsening and fear of the storage of tissue or genetic information were all suggested. Language was also thought to play a role. As discussed in the section “Participant characteristics”, some interviewees observed that individuals who spoke English as an additional language were more reluctant to participate compared with native English speakers.

“I have noticed sometimes, I’ve not quantified this yet, because we haven’t analysed out results, but people who maybe don’t have English as a first language are probably a bit more reluctant” . (Speciality registrar, team A)

Specific issues for London

When asked specifically about recruitment issues associated with their location in London, the researchers’ responses fell into two main themes: local research community and patient population.

Local research community

The interviewees described successful research communities within their own teams, although there was a lack of collaboration with local primary care services. It was suggested that establishing shared research databases and other systems to identify and access potentially eligible patients across different service providers would be beneficial for study recruitment, but that specific initiatives would be needed to facilitate this.

“It’s hard because, in my view, if you really want to do it, it will cost money. It will involve someone, a GP with a research interest in the catchment area. For example, they call it GPSI, which is a GP with a specialist interest in something, rheumatology or haematology et cetera, but one would have research, just purely doing research” . (Specialty registrar, team C)

In addition, researchers reported delays in the process of gaining ethical approval for their studies and a lack of financial support for in-house academic research, suggesting that local improvements could be made to these systems.

Despite these recommendations for improvement, the interviewees were generally positive about working in London and the level of research support provided.

“I think in terms of being in a big London teaching hospital, we are more geared up to research, just from personal experience having worked in district generals in [UK county], there was no set up for research and it was very much a minor thing, and if anyone was doing something, they didn’t have research nurses, it was very much clinician led. It was set up in their own interests really, their own studies. So the fact that we have a forum for research nurses here, and we are trying to actively put out the research message” . (Research nurse, team A)

Patient population

It was noted by the researchers that patients attending hospital appointments in London frequently report long travel times and this was believed to be detrimental to recruitment. This was attributed to the broad catchment area for tertiary healthcare, plus the large number of people who commute into London for work. Interviewees reported difficultly recruiting patients with long journey times, especially if research participation involved additional visits.

“There’s quite a large population of people that travel in. I guess that will affect people taking part in research. Because if they’re having to travel from Hertfordshire, that’s going to put people off, because yes, you can give them their travel expenses, but you can’t give them their three hours back” . (Research nurse, team C)

Being a tertiary care centre was also thought to have a positive effect on recruitment, with researchers commenting that patients may be more likely to trust an invitation for research participation from a specialist centre.

“So people do come in from other hospitals. Again, you have a wider group. Also, they tend to be, in a way, more sick. More likely to listen to the medic who’s telling them, ‘this isn’t a bad thing’” . (Clinical research scientist, team C)

The interviewees also discussed the diversity of the local population, and as mentioned previously, the lack of interpretation and translation services for research resulting in potentially eligible patients being excluded. However, in general it was felt that the researchers were able to recruit representative samples of their local populations.

Although all these issues were important to researchers, it was also acknowledged that most locations have problems with recruitment and that having sufficient resources and research staff should perhaps be considered more important than the location.

“I wouldn’t say there are any huge differences that I can think of. I think it really does depend on the staff and the resources that they’ve got, rather than the actual hospital and the patients coming in” . (Clinical research associate, team A)

The primary aim of this study was to identify the factors that researchers perceive as influential in the recruitment of participants to their clinically focused research. Infrastructure, the nature of the research, recruiter characteristics and participant characteristics were all deemed important. The first three themes are, in theory, more amenable to modification than the last, for example through the development of systems to improve identification and access to eligible participants [ 18 ], designing studies with reduced participant burden [ 10 ] and ensuring that recruiters have the appropriate knowledge and skills [ 19 ]. The discussion of participant characteristics focused on the concept that certain patients were thought more likely to agree to research participation than others. The danger with such an observation is the potential for recruiters to stereotype potential participants based on previous experiences, and therefore choose not to approach individuals who are otherwise eligible. As the NHS constitution pledges to inform all patients of research studies that are relevant to them and in which they may be eligible to participate [ 20 ], recruiters must be aware of the potential to deviate from this duty. In reality, the decision to participate in clinically focused research is frequently multifaceted and requires potential participants to consider the personal pros and cons of taking part at any given time [ 13 ]. The research nurses interviewed for the current study raised this point and explained their attempts to approach all eligible patients, regardless of any preconceptions about whether or not they would agree to participate.

The general perception that doctors are more successful at recruiting research participants than nurses has been explored previously. Donovan et al. [ 21 ] found no significant difference in recruitment rates between urology consultants and nurses for a prostate cancer RCT and calculated that nurses were more cost-effective recruiters, despite spending longer on average with each patient. In the current study, recruitment was viewed more as a team effort. Having the doctor mention research participation as part of the routine consultation was thought to be beneficial, as was having integrated clinical and academic teams on site. However, these strategies require sufficient staffing and resources and rely on specific funding for research posts [ 9 ]. The possible recruitment benefits of having an established therapeutic relationship with potential study participants [ 22 ], sharing similar cultural backgrounds or languages [ 23 ], and employing peer recruiters [ 24 , 25 ] have all been explored in the literature. However, the influence of the recruiter-participant relationship was not widely discussed by the interviewees, nor were the subjects of culture and ethnicity. There was a general consensus that recruiters adopted the same recruitment strategies for all demographic groups, but observational investigations of recruitment practices would be beneficial to further explore these issues. The use of eligibility criteria that include only those who speak sufficient English was attributed to a lack of resources available for interpreter services. Resource limitations would also restrict the use of peer recruitment programmes or other strategies aimed at including minority groups. As recruiting a representative sample is essential for the generalisability of research findings [ 26 ], additional investigation of this issue is required.

The research scientists interviewed were disappointed that they were no longer permitted to discuss their study directly with potential participants. This finding echoes the views of biomedical research scientists involved in placental perfusion studies [ 27 ]. The scientists raised legitimate concerns that the individuals involved in recruitment did not have sufficient knowledge of the intricacies of the study to be able to fully explain the background and rationale to potential participants, or to answer questions about particular methodologies [ 19 ]. It in current study, it was local, rather than national, policy that dictated the exclusion of research scientists from recruitment activities. The potential benefits of allowing research scientists to recruit participants to their research include reducing the workload for clinicians, providing expert knowledge of the study processes and rationale, and separating research recruitment from routine clinical care. The potential drawbacks include the research scientist having a vested interest in the research without the balance of coexisting clinical duties, and the absence of a previous therapeutic relationship with the patient. Further exploration of this issue is required, however it may be advantageous to consider including clinical research scientists as part of the recruitment team, with safeguards to guarantee that patients are not exploited.

The recommendation to use an opt-out system, where patients are required to contact the research team if they do not wish to be invited to participate in clinical research, was made in a recent systematic review [ 3 ]. Several interviewees suggested that this might be a beneficial system, however this strategy is not currently employed, and further work is required to pilot the use of opt-out within these settings. A variation of this strategy, where patients are invited to opt-in to the anonymous donation of surplus tissue after clinical tests, was also discussed. This type of tissue biobanking is available at the interviewees’ hospital sites for patients with a diagnosis of cancer, but is not routinely adopted in other clinical areas. Further research into the extension of biobanks to include other clinical specialties appears warranted [ 28 ].

The use of open, rather than blinded trial designs, and telephone reminders were also recommended by Treweek et al. [ 3 ]. There is debate over the utility of open study designs due to the potential for increased bias [ 29 ], but this methodology is gaining support [ 30 ]. The interviewees used modified versions of this strategy, such as having an open or crossover phase after the main trial, and believed this was beneficial for recruitment. None of the interviewees specifically discussed the use of telephone reminders.

The recruitment strategies employed by the interviewees were similar to those identified in our recent meta-synthesis, although there was less focus on emphasising the benefits of research participation in the current study [ 9 ]. In addition to the possible coercive aspect of emphasising the benefits , the interviewees believed that altruism was the key reason for patients accepting the invitation to participate, and therefore strategies based on highlighting potential personal benefits would not sit with this premise. The dominance of practical issues as proposed reasons for patients declining the invitation to participate in research have been documented elsewhere [ 9 , 10 ].

The key factors associated with conducting clinically focused research in London were language and travel time. Interviewees were unable to offer interpretation services to facilitate discussions about research with patients who did not speak sufficient English. The most recent government data shows that within the associated South London boroughs between 19.6-20.3 % of residents do not speak English as their primary language, compared with 15.3 % and 7.1 % in the next biggest UK cities Birmingham and Leeds, respectively [ 31 ]. The range of primary languages spoken is also greater in the interviewees’ regions, with more than 54 different languages, compared to 36 in Birmingham and 29 in Leeds [ 31 ]. Traditionally, individuals from ethnic minorities have been considered less likely to participate in clinically focused research, however studies from the USA suggest that this is not the case and recommend that more needs to be done to ensure access to research for minority groups, rather than interventions aimed at increasing willingness [ 32 - 34 ]. Strategies to aid the removal of language barriers identified in the current study would improve access to research and could potentially increase recruitment, however further investigation is required.

The interviewees also observed that patients with long travel times to the hospital were less willing to take part in research. When designing clinically focused studies, it may therefore be useful to explore the interviewees’ suggestions of increasing the use of information technology for data collection and forming collaborations with local healthcare services to minimise participant travel. As the average commuting time is 48 % longer in London than elsewhere in the country [ 35 ] this factor may be less problematic in other locations, however most tertiary and quaternary healthcare services conducting research are likely to experience similar travel issues.

Strengths and limitations

The current study adds to previous work by providing experiential reports and perceptions from research teams in three different non-cancer outpatient settings, within a specified geographical location. However, as the research teams involved were based in South London, further work is required to ascertain whether these findings translate to other regions, nationally and internationally.

Although interviewing was continued until saturation, the small sample size in the current study means it is not possible to infer any differences between the experiences and opinions of the different professions within the research teams. Furthermore, the current study relied on information collected from semi-structured interviews, and may have been subject to reporter bias. Attempts were made to minimise the degree of bias by selecting independent research teams and interviewing participants individually. Additional explorations of the researchers’ practices that include observation of the recruitment situation would be beneficial, but were beyond the scope of the current study.

Infrastructure, nature of the research, recruiter characteristics and participant characteristics were all believed to influence the success of recruitment to clinically focused research. Suggestions to improve recruitment included reducing participant burden, providing support for individuals who do not speak English and forming collaborations with primary care to improve identification of, and access to, potentially eligible patients. Despite the focus on London in the current study, the factors identified are not unique to this location and are therefore likely to be representative of other diverse cities within the UK.

Competing interests

There were no competing interests in the conduct of this study.

Authors’ contributions

LN and AM made substantial contributions to the design of the study. LN carried out the interviews, conducted the analysis and wrote the final manuscript. AM advised on research conduct from inception to completion, appraised the analysis process and revised the manuscript. Both authors read and approved the final manuscript.

Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2288/14/10/prepub

Acknowledgements

The authors would like to thank and acknowledge the contribution of the researchers who gave their time to be interviewed for this study.

This research was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I. et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006; 7 :9. doi: 10.1186/1745-6215-7-9. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Equity and Excellence: Liberating the NHS. http://www.gov.uk/government/publications/liberating-the-nhs-white-paper .
  • Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C. et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013; 3 :e002360. [ PMC free article ] [ PubMed ] [ Google Scholar ]
  • Brown WJ, Bryson L, Byles JE, Dobson AJ, Lee C, Mishra G, Schofield M. Women’s Health Australia: recruitment for a National Longitudinal Cohort Study. Women Health. 1999; 28 (1):23–40. doi: 10.1300/J013v28n01_03. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Dennis BP, Neese JB. Recruitment and retention of African American elders into community-based research: lessons learned. Arch Psychiatr Nurs. 2000; 14 (1):3–11. doi: 10.1016/S0883-9417(00)80003-5. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Steinhauser KE, Clipp EC, Hays JC, Olsen M, Arnold R, Christakis NA, Lindquist JH, Tulsky JA. Identifying, recruiting, and retaining seriously-ill patients and their caregivers in longitudinal research. Palliat Med. 2006; 20 (8):745–754. doi: 10.1177/0269216306073112. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Seed M, Juarez M, Alnatour R. Improving recruitment and retention rates in preventive longitudinal research with adolescent mothers. J Child Adolesc Psychiatr Nurs. 2009; 22 (3):150–153. doi: 10.1111/j.1744-6171.2009.00193.x. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annu Rev Public Health. 2006; 27 (1):1–28. doi: 10.1146/annurev.publhealth.27.021405.102113. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Newington L, Metcalfe A. Researchers’ and clinicians’ perceptions of recruiting participants to clinical research: a thematic meta-synthesis. J Clin Med Res. 2013. In Press. [ PMC free article ] [ PubMed ]
  • Cox K, McGarry J. Why patients don’t take part in cancer clinical trials: an overview of the literature. Eur J Cancer Care (Engl) 2003; 12 (2):114–122. doi: 10.1046/j.1365-2354.2003.00396.x. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Blanch DC, Rudd RE, Wright E, Gall V, Katz JN. Predictors of refusal during a multi-step recruitment process for a randomized controlled trial of arthritis education. Patient Educ Couns. 2008; 73 (2):280–285. doi: 10.1016/j.pec.2008.06.017. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Madsen SM, Holm S, Davidsen B, Munkholm P, Schlichting P, Riis P. Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Intern Med. 2000; 248 (6):463–474. doi: 10.1046/j.1365-2796.2000.00755.x. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Verheggen FWSM, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial. Patient Educ Couns. 1998; 35 (2):111–125. doi: 10.1016/S0738-3991(98)00060-3. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Webb MS. Focus groups as an intervention for low-income African-American smokers to promote participation in subsequent intervention studies. Res Nurs Health. 2008; 31 :141–151. doi: 10.1002/nur.20239. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Gilbert H, Leurent B, Sutton S, Morris R, Alexis-Garsee C, Nazareth I. Factors predicting recruitment to a UK wide primary care smoking cessation study (the ESCAPE trial) Fam Pract. 2012; 29 (1):110–117. doi: 10.1093/fampra/cmr030. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Menon U, Gentry-Maharaj A, Ryan A, Sharma A, Burnell M, Hallett R, Lewis S, Lopez A, Godfrey K, Oram D. et al. Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study. BMJ. 2008; 337 :a2079. doi: 10.1136/bmj.a2079. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Ritchie J, Spencer L. In: Analyzing Qualitative Data. Bryman A, Burgess RG, editor. London: Routledge; 1994. Qualitative data analysis for applied policy research; pp. 172–194. [ Google Scholar ]
  • Patterson S, Mairs H, Borschmann R. Successful recruitment to clinical trials: a phased approach to opening gates and building bridges. BMC Med Res Methodol. 2011; 11 (73) doi: 10.1186/1471-2288-11-73. [ PMC free article ] [ PubMed ] [ Google Scholar ]
  • Ziebland S, Featherstone K, Snowdon C, Barker K, Frost H, Fairbank J. Does it matter if clinicians recruiting for a trial don’t understand what the trial is really about? Qualitative study of surgeons’ experiences of participation in a pragmatic multi-centre RCT. Trials. 2007; 8 :4. doi: 10.1186/1745-6215-8-4. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • The handbook to the NHS Constitution. http://www.gov.uk/government/publications/the-nhs-constitution-for-england .
  • Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, Lane JA, Neal DE, Hamdy FC. Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study) J Clin Epidemiol. 2003; 56 (7):605–609. doi: 10.1016/S0895-4356(03)00083-0. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Jenkins V, Fallowfied L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000; 82 (11):1783–1788. doi: 10.1054/bjoc.2000.1142. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Quinn SC, Butler J III, Fryer CS, Garza MA, Kim KH, Ryan C, Thomas SB. Attributes of researchers and their strategies to recruit minority poulations: results of a national survey. Contemp Clin Trials. 2012; 33 :1231–1237. doi: 10.1016/j.cct.2012.06.011. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Larkey LK, Staten LK, Ritenbaugh C, Hall RA, Buller DB, Bassford T, Altimari BR. Recruitment of hispanic women to the women’s health initiative: the case of Embajadoras in Arizona. Control Clin Trials. 2002; 23 (3):289–298. doi: 10.1016/S0197-2456(02)00190-3. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Bean S, Silva DS. Betwixt & between: peer recruiter proximity in community-based research. Am J Bioeth. 2010; 10 (3):18–19. doi: 10.1080/15265160903581783. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Kruskal W, Mosteller F. Representative sampling, III: the current statistical literature. Int Stat Rev. 1979; 47 (3):245–265. doi: 10.2307/1402647. [ CrossRef ] [ Google Scholar ]
  • Halkoaho A, Pietila AM, Vahakangas K. Ethical aspects in placental perfusion studies: views of the researchers. Placenta. 2011; 32 (7):511–515. doi: 10.1016/j.placenta.2011.04.006. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Marko-Varga G. BioBanking - the holy grail of novel drug and diagnostic developments? J Clin Bioinformatics. 2011; 1 (1):14. doi: 10.1186/2043-9113-1-14. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Day SJ, Altman DG. Blinding in clinical trials and other studies. BMJ. 2000; 321 (7259):504. doi: 10.1136/bmj.321.7259.504. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Büller HR, Halperin JL, Bounameaux H, Prins M. Double-blind studies are not always optimum for evaluation of a novel therapy: The case of new anticoagulants. J Thromb Haemost. 2008; 6 (2):227–229. [ PubMed ] [ Google Scholar ]
  • 2011 Census: QS204EW Main language (detailed), unitary authorities in Wales. (Release date 30 January 2013) [ http://www.ons.gov.uk/ons/datasets-and-tables/index.html ]
  • Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2005; 3 (2):e19. [ PMC free article ] [ PubMed ] [ Google Scholar ]
  • Katz RV, Kegeles S, Kressin NR, Green B, Wang M, James SA, Russell SL, Claudio C. The Tuskegee legacy project: willingness of minorities to participate in biomedical research. J Health Care Poor Underserved. 2006; 17 (4):698–715. doi: 10.1353/hpu.2006.0126. [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Ness RB, Nelson DB, Kumanyika SK, Grisso JA. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol. 1997; 7 (7):472–478. doi: 10.1016/S1047-2797(97)00080-X. [ PubMed ] [ CrossRef ] [ Google Scholar ]
  • Personal travel factsheet: commuting and business travel. [ http://www.gov.uk/government/uploads/system/uploads/attachment_data/file/49703/Commuting_and_business_travel_factsheet___April_2011.pdf ]

IMAGES

  1. Clinical Trial Recruitment Infographic

    clinical research recruitment techniques

  2. How to Ensure On-time Patient Recruitment in Clinical Trials

    clinical research recruitment techniques

  3. How To Improve Patient Recruitment In Clinical Trials?

    clinical research recruitment techniques

  4. Patient Recruitment for Clinical Trials #5: Strategy

    clinical research recruitment techniques

  5. Recruitment in Clinical Trials

    clinical research recruitment techniques

  6. Patient Recruitment Strategies

    clinical research recruitment techniques

VIDEO

  1. Ever wonder what Clinical Research Associates do?

  2. Day in a Life of a Clinical Research Associate ✨

  3. Clinical Trial Coordinator Recruitment

  4. Some of the Key Job Profiles in Clinical Research

  5. Group-B Section and Assistant Section Officer Posts Notification || CSIR Recruitment 2023

  6. 3 Tactics for More Diverse Clinical Trial Recruitment

COMMENTS

  1. 10 clinical trial recruitment strategies that work

    9. Use patient follow-up services. Though a clinical trial is a major focus for a sponsor, for patients, signing up for a trial may be a task that is continually pushed to the bottom of a long to-do list. Automated follow-up services, such as texts and emails, can nudge patients to take the next step without being invasive.

  2. 7 Clinical Trial Recruitment Strategies For 2024

    A patient recruitment plan aims to maximize enrolment by a series of steps. It typically employs a basic template of: Research - Identify the target audience and any obstacles they may face when joining the trial. Outreach - Establish a budget, and decide on your methods of interacting with your pool of patients.

  3. Clinical Trial Recruitment 101: How to Recruit Participants for a Study

    There is no simple answer to the question of how to recruit participants for a study in clinical research. The ideal recruitment strategy will depend on the specifics of the trial type and protocol, the capabilities of the sponsor and/or entity conducting the trial, the availability of eligible participants, and certain demographic and ...

  4. PDF Tips and Tricks for Successful Research Recruitment

    recommendations for large clinical trials, and the use of social media as well and community based research. It will also address recruitment challenges and keys to high retention. The recruitment toolkit highlights effective strategies for investigators and others to work in diverse populations.

  5. PDF CTTI Recommendations: Planning for Successful Trial Recruitment

    research challenges and improve the quality and efficiency of a trial. The recommendations and resources outlined below cover all areas of clinical research recruitment—from making sure the study is asking the right questions, to shaping study design and feasibility, to budget and implementation. Used holistically, or in part, they

  6. Successful Recruitment to Qualitative Research: A Critical Reflection

    The methodology literature contains articles chronicling recruitment difficulties in qualitative research (e.g., Bonisteel et al., 2021; Price et al., 2020), but reports of successful recruitment are limited.Motivations to participate in research have received some attention in the literature, but such accounts of motivation are largely anecdotal and from the perspective of the researcher (e.g ...

  7. 2024 A Guide to Clinical Trial Recruitment

    Proven Methods for In-House Clinical Trial Patient Recruitment. Done right, many low-cost clinical trial marketing techniques have high ROI. They work hand in hand with paid media buys and other clinical trial advertising in the digital age. A multi-pronged strategy adopted early is more likely to prove effective than sticking with a single ...

  8. Participant and patient engagement, recruitment, and retention

    In fact, effective engagement, recruitment and retention planning should: Take time. Be proactive. Start upstream at study design. Anticipate and account for downstream barriers. Be data-driven and evidence-based. Be thoughtful and realistic. Include input from all relevant stakeholders. Be participant-centered.

  9. PDF Patient Recruitment in Clinical Trials: Steps to Develop a Successful

    most challenging. During Forte's 2017 national survey of over 900 clinical research professionals, recruiting enough participants to trial was identified as one of the top three pain points in clinical trial conduct. So, why is it that such an important element of clinical research is also one of the most difficult to execute?

  10. A Comprehensive Guide to Clinical Recruitment Strategies

    According to ACRP, 30% of individuals withdraw from a clinical study prior to completion, and recruiting a replacement costs an average of $19,533.Psychiatry has been poised for disruption for decades, and pharmaceutical companies are looking for solutions to bridge the gap between participant recruitment and drug research and development.

  11. 5 patient recruitment strategies for clinical trials

    Clinical research sponsors typically start recruitment efforts by evaluating their own patient databases at sites. Having physicians at your sites who can connect patients with research opportunities is another free recruitment option. As you start to create your recruitment plan, consider approximately how many patients you have direct ...

  12. Improving trial recruitment processes: how qualitative methodologies

    Qualitative research methods have been used to address various aspects of randomised trials; these include developing and understanding the acceptability of the intervention being trialled, the trial design, process and conduct (including recruitment and retention), explaining trial outcomes, and providing contextual understanding of the target ...

  13. Digital tools for the recruitment and retention of participants in

    The problem: inadequate patient recruitment and retention. Recruiting and retaining participants in clinical and health studies is a key determinant of research efficiency, but is highly challenging [1, 2], and poor rates of recruitment to randomised controlled trials (RCTs) are commonly reported [].In reviews of clinical trials funded by the UK Medical Research Council and/or the National ...

  14. The Recruitment Innovation Center: Developing novel, person-centered

    Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of ...

  15. How to optimize patient recruitment

    However, in clinical research, detecting a statistically significant difference between groups may not be clinically relevant. For example, consider 2 competing treatments for tibia shaft fractures. ... Referral and flyer recruitment methods were the most effective, yielding the highest number of enrolments. Recruitment in surgical trials has ...

  16. Effectiveness of participant recruitment strategies for critical care

    Kearney A, Harman NL, Rosala-Hallas A, et al. Development of an online resource for recruitment research in clinical trials to organise and map current literature. Clin Trials 2018; 15(6): 533-542. Crossref. ... Sage Research Methods Supercharging research opens in new tab; Sage Video Streaming knowledge opens in new tab;

  17. Real-time evaluation and adaptation to facilitate rapid recruitment in

    Targeted recruitment methods focused on individuals who were more likely to meet inclusion/exclusion criteria. Broad methods reached a larger population that resulted in a lower percentage of eligible individuals. ... our key findings can be summarized by these five recommendations to consider from the outset of a clinical research study: 1 ...

  18. Recruitment and retention of the participants in clinical trials

    This paper focuses on recruitment and retention of patients/healthy participants in a clinical study, based on our experiences in conducting both regulatory and investigator-initiated clinical research in a tertiary care hospital, and puts forth the challenges and potential solutions to address these aspects. Go to:

  19. 5 Key Strategies for Clinical Trial Patient Recruitment

    A patient-centric approach! Let's take a look at some of the best techniques for patient recruitment in clinical trials. The 5 key strategies to consider for successful patient recruitment. 1. Identify your patient population: Before you start recruiting patients, it's important to have a clear understanding of who you're targeting. This might ...

  20. Clinical Research Recruitment

    Successful research studie s are built on the foundation of diligent recruitment, and that's where we come in. As a dedicated Clinical Trials Recruitment team, our purpose is to streamline the recruitment process for investigators and study teams, making it as efficient and effective as possible. We recognize that finding and enrolling the right participants is crucial to the success of your ...

  21. Interventions to improve recruitment and retention in clinical trials

    Background Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions. Methods In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data ...

  22. Finding the right candidate: Developing hiring guidelines for screening

    Methods/Study Population: ... Clinical research coordinators (CRCs) are responsible for overseeing the day-to-day operations of clinical research trials and studies. Recruiting and hiring a qualified individual to coordinate research studies can be the key to the successful launch and execution of many research projects. There are currently an ...

  23. The Latest Tools and Approaches for Clinical Researchers

    Clinical trials are the gold standard for testing the effectiveness of treatment interventions for both common and rare conditions, yet the time and financial investment required to find and recruit eligible patients can be cumbersome. That's why it's important for clinical researchers to become familiar with some of the latest trends in research that can provide feasible alternative ...

  24. Interventions to improve recruitment and retention in clinical trials

    The Medical Research Council Systematic Techniques for Assisting Recruitment to Trials (MRC START) program and related initiatives such as Studies Within A Trial (SWAT) and TrialsForge may encourage a common framework across recruitment interventions and pooling to provide a more precise estimate of their effects, and to explore variation in ...

  25. Factors influencing recruitment to research: qualitative study of the

    Recruiting the required number of participants is vital to the success of clinical research and yet many studies fail to achieve their expected recruitment rate. Increasing research participation is a key agenda within the NHS and elsewhere, but the optimal methods of improving recruitment to clinical research remain elusive.