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Bile acid malabsorption (BAM) is characterized by chronic watery diarrhea resulting from excessive bile acids in the feces. BAM is often an overlooked cause of chronic diarrhea, with its prevalence not being sufficiently researched.

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The field of kidney transplantation is being revolutionized by the integration of artificial intelligence (AI) and machine learning (ML) techniques. AI equips machines with human-like cognitive abilities, while ML enables computers to learn from data.

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Acute kidney injury (AKI) affects increasing numbers of in-hospital patients in Central Europe and the USA, the prognosis remains poor. Although substantial progress has been achieved in the identification of molecular/cellular processes that induce and perpetuate AKI, more integrated pathophysiological perspectives are missing.

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Subjects with mild cognitive impairment (MCI) can progress to dementia. Studies have shown that neuropsychological tests, biological or radiological markers individually or in combination have helped to determine the risk of conversion from MCI to dementia.

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Atrial fibrillation (AF) is the most common arrhythmia with a growing prevalence worldwide, especially in the elderly population. Patients with AF are at higher risk of serious life-threatening events and complications that may lead to long-term sequelae and reduce quality of life.

Vol. 16, No. 4, Apr 2024

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Clinical Medicine Research

  • © 2018
  • Mieczyslaw Pokorski 0

Opole Medical School, Opole, Poland

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  • Advancing new ideas and knowledge
  • Innovative and insightful clinical research
  • Dissemination of best clinical practice

Part of the book series: Advances in Experimental Medicine and Biology (AEMB, volume 1116)

Part of the book sub series: Clinical and Experimental Biomedicine (CLEXBI)

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76 Citations

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Table of contents (12 chapters)

Front matter, bioprogressive paradigm in physiotherapeutic and antiaging strategies: a review.

  • Mieczyslaw Pokorski, Giovanni Barassi, Rosa G. Bellomo, Loris Prosperi, Matteo Crudeli, Raoul Saggini

Influence of Proprioceptive Neuromuscular Facilitation on Lung Function in Patients After Coronary Artery Bypass Graft Surgery

  • Małgorzata Bujar-Misztal, Andrzej Chciałowski

Remote Ischemic Preconditioning in Renal Protection During Elective Percutaneous Coronary Intervention

  • Małgorzata Wojciechowska, Maciej Zarębiński, Piotr Pawluczuk, Dagmara Gralak-Łachowska, Leszek Pawłowski, Wioletta Loska et al.

Prognostic Impact of Extracapsular Lymph Node Invasion on Survival in Non-small-Cell Lung Cancer: A Systematic Review and Meta-analysis

  • Seyed Vahid Tabatabaei, Christoph Nitche, Maximilian Michel, Kurt Rasche, Khosro Hekmat

Influence of Transurethral Resection of Bladder Cancer on Sexual Function, Anxiety, and Depression

  • Wojciech Krajewski, Urszula Halska, Sławomir Poletajew, Radosław Piszczek, Bartosz Bieżyński, Mateusz Matyjasek et al.

Cognitive Predictors of Cortical Thickness in Healthy Aging

  • Patrycja Naumczyk, Angelika K. Sawicka, Beata Brzeska, Agnieszka Sabisz, Krzysztof Jodzio, Marek Radkowski et al.

Osteoprotegerin, Receptor Activator of Nuclear Factor Kappa B Ligand, and Growth Hormone/Insulin-Like Growth Factor-1 Axis in Children with Growth Hormone Deficiency

  • Ewelina Witkowska-Sędek, Małgorzata Rumińska, Anna Stelmaszczyk-Emmel, Maria Sobol, Urszula Demkow, Beata Pyrżak

Inhibition of Cross-Reactive Carbohydrate Determinants in Allergy Diagnostics

  • Maciej Grzywnowicz, Emilia Majsiak, Józef Gaweł, Karolina Miśkiewicz, Zbigniew Doniec, Ryszard Kurzawa

Effects of Glutathione on Hydrolytic Enzyme Activity in the Mouse Hepatocytes

  • Iwona Stanisławska, Bożena Witek, Marek Łyp, Danuta Rochon-Szmejchel, Adam Wróbel, Wojciech Fronczyk et al.

Adaptation to Occupational Exposure to Moderate Endotoxin Concentrations: A Study in Sewage Treatment Plants in Germany

  • M. A. Rieger, V. Liebers, M. Nübling, T. Brüning, B. Brendel, F. Hoffmeyer et al.

Effects of Low-Level Laser Therapy in Autism Spectrum Disorder

  • Gerry Leisman, Calixto Machado, Yanin Machado, Mauricio Chinchilla-Acosta

Epidemiology of Granulomatosis with Polyangiitis in Poland, 2011–2015

  • Krzysztof Kanecki, Aneta Nitsch-Osuch, Paweł Gorynski, Patryk Tarka, Magdalena Bogdan, Piotr Tyszko
  • Bioprogressive treatment
  • Cancer research
  • Cognitive function
  • Coronary disease
  • Diagnostic markers
  • Growth hormone
  • Health care
  • Occupational endotoxins
  • Physiotherapy

About this book

This book presents an update on new trends and developments in broadly defined medical disciplines. The whole range of multidisciplinary topics are tackled, regarded as being important for advancing the understanding of disease pathogenicity, diagnostic methods, and patient management. The topics include a holistic approach to physiotherapy, with proprioceptive neuromuscular facilitation at the core of it, potential ways to protect kidneys during ischemic coronary interventions, and psychosocial aspects in cancer survivors. Other topics deal with growth hormone deficiency in short children and responses of molecular markers of bone metabolism to growth hormone replacement therapy and with the modern use of transcranial laser-induced photobiomodulation showing surprising benefits in autism disorder. The expert contributions take on the challenges presented to medical professionals by ever growing medical knowledge and various individual and contextual issues that require a multidisciplinary approach in patient management. The authors present a bench-to-bed clinical research to make useful additions to the knowledge on contemporary diagnostic procedures, therapy, and quality of life of patients. The book aims to provide stimulus for new research ideas and to give new perspectives on practical clinical issues. The book is intended for primary care clinicians, family physicians, medical scholars, and other clinicians who treat and manage patients.

Editors and Affiliations

Mieczyslaw Pokorski

About the editor

Bibliographic information.

Book Title : Clinical Medicine Research

Editors : Mieczyslaw Pokorski

Series Title : Advances in Experimental Medicine and Biology


Publisher : Springer Cham

eBook Packages : Biomedical and Life Sciences , Biomedical and Life Sciences (R0)

Copyright Information : The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2018

Hardcover ISBN : 978-3-030-04836-5 Published: 04 December 2018

eBook ISBN : 978-3-030-04837-2 Published: 23 November 2018

Series ISSN : 0065-2598

Series E-ISSN : 2214-8019

Edition Number : 1

Number of Pages : VI, 138

Number of Illustrations : 13 b/w illustrations, 6 illustrations in colour

Topics : Neurochemistry , Cancer Research , Physiotherapy , Cytokines and Growth Factors

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Combination Therapy in Bladder Cancer

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Thank you to all the peer reviewers who generously donated their time and expertise to Clinical Medicine Research publications. Your contributions are invaluable in maintaining the high-quality standards of our publications.

  • Assoc. Prof. Zhang Haiyu Department of Transfusion Blood, Sichuan Cancer Hospital, Chengdu, China
  • Assoc. Prof. Neha Hajira Department of Prosthodontics, Rural Dental College, Pravara Institute of Medical Sciences (Deemed University), Ahmednagar, India

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Engaging in the peer review process not only significantly contributes to the scientific community but also brings considerable benefits for your own research and career development. At SciencePG, we always appreciate and welcome professionals who are interested in becoming part of our dedicated reviewer team.

Clinical Medicine Research maintains an Editorial Board of practicing researchers from around the world, to ensure manuscripts are handled by editors who are experts in the field of study.

  • Wahab Owolawi Department of Audiology, University of Medical Sciences, Ondo, Nigeria
  • Prof. Carolina Mahuad Department of Hematology, Hospital Alemán, Buenos Aires, Argentina
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Joining the Editorial Board is an opportunity to be recognized as an expert in your field and to contribute to the peer review process of cutting-edge research. By acting as editor, you will have the opportunity to shape the future of research in your field and be part of a community of like-minded researchers.

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Tanshinone IIA Regulate Inflammatory Response and Promote Functional Recovery in Rats with Spinal Cord Injury

Authors: Bin Lin , ... Aini Lin

Pages: 17-22 Published Online: 29 April 2024

DOI: 10.11648/j.cmr.20241302.11

Crossed Cerebellar Diaschisis and Cerebral Infarction After Cerebral Hyperperfusion Syndrome Following Carotid Artery Stenting: A Case Report

Authors: Wei-Qin Ning , ... Shui-Sheng Zhong

Pages: 13-16 Published Online: 21 February 2024

DOI: 10.11648/j.cmr.20241301.13

Combining Multiple Tumor Markers to Construct a Clinical Prediction Model for Breast Cancer

Authors: Zebin Liu , ... Liying Qiu

Pages: 6-12 Published Online: 8 January 2024

DOI: 10.11648/j.cmr.20241301.12

Therapeutic Effect of Hydroalcoholic Extract for Withania Coagulans for Diuretic Activity in Rodents

Authors: Rajesh Kumar Sharma , ... Sanjana Soni

Pages: 1-5 Published Online: 8 January 2024

DOI: 10.11648/j.cmr.20241301.11

Development and Evaluation of a Questionnaire on the Acceptability of Advance Care Planning for the Families of End-Stage Patients with Chronic Diseases

Authors: Shen Yongqing , ... Li Dongli

Pages: 103-109 Published Online: 29 November 2023

DOI: 10.11648/j.cmr.20231206.11

Mechanisms of Iron Deficiency in Obese Children

Author: Xin-yan Yan

Pages: 95-102 Published Online: 14 October 2023

DOI: 10.11648/j.cmr.20231205.12

Science Publishing Group (SciencePG) is an Open Access publisher, with more than 300 online, peer-reviewed journals covering a wide range of academic disciplines.

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  • Year in Review
  • Published: 23 December 2022

11 clinical trials that will shape medicine in 2023

  • Carrie Arnold 1 &
  • Paul Webster 2  

Nature Medicine volume  28 ,  pages 2444–2448 ( 2022 ) Cite this article

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This article has been updated

Nature Medicine asks leading researchers to name their top clinical trial for 2023, from cervical and prostate cancer screening to new drugs for Parkinson’s disease and Alzheimer’s disease.

2022 has been a rollercoaster year for biopharma, as it has faced an industry-wide slowdown and late-stage clinical trial failures, as well as breakthroughs and regulatory approvals.

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COVID-19 has continued to disrupt nearly all aspects of clinical trial infrastructure, from patient recruitment to supply chains, but despite this, 2023 promises to bring many new readouts from different branches of medicine (Table 1 ).

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We asked 11 leading experts for their top clinical trials to watch in the coming year.

A diabetes drug for Parkinson’s disease

Roger Albin: For both purely scientific issues and clinical practice issues, the phase 3 trial for exenatide in Parkinson’s disease is a very attractive trial. It has the big advantage of being a repurposed drug that is already widely used in older patients. If there were a positive result, it is something that could be really adopted into clinical practice in a very practical way. The drug had reasonable preclinical data and some promising phase 2 data, and in the Parkinson’s disease world, in which there is not an animal model for really great predictive validity, this is probably about as good as it gets. The community is looking for unequivocal results, whether positive or negative. A clear positive response would be great, but a clear negative response is actually just as important.

Roger Albin is a professor of neurology and co-director of the Movement Disorders Clinic in the Department of Neurology at the University of Michigan Medical School .

ADC for ovarian cancer

Robert L. Coleman: The most imminent and important upcoming trial result expected in my field in 2023 is mirvetuximab soravtansine, from ImmunoGen. This received accelerated approval from the US Food and Drug Administration (FDA) on 14 November, based on results of a single-arm trial that enrolled 106 patients with platinum-resistant ovarian cancer whose tumors had high expression of folate receptor-α and who had been treated with up to three prior regimens, at least one of which included bevacizumab (Avastin).

Under accelerated approval, the sponsor can market their drug under the indication agreed to by the FDA — in this case, patients with recurrent, platinum-resistant ovarian cancer. For the drug to move from accelerated approval to regular approval, a confirmatory trial needs to be conducted to confirm the overall safety and efficacy of the agent of interest. In this case, initial results for the confirmatory phase 3 MIRASOL trial are expected in early 2023.

This drug is an antibody–drug conjugate (ADC); these agents are already being used for the treatment of several solid and liquid tumors, but this is the first for ovarian cancer. It will be aligned with a companion diagnostic test that mirrors the expression in tumors needed for clinical trial eligibility. We expect about one-third of patients with recurrent, platinum-resistant ovarian cancer to have high expression of folate receptor-α. The ADC field is expanding rapidly, with trastuzumab deruxtecan approved in April 2022 for use against breast cancer, but it has been a long time since a new cytotoxic agent has been approved for ovarian cancer. Among treatments for gynecological cancers, this is only the second ADC approved so far, after Tisotumab vedotin (in September 2021) for patients with recurrent previously treated cervical cancer. Now we have one in ovarian cancer. Several other ADCs are in development, and successful approval will provide a solid framework for clinical trials evaluating novel combinations in several disease settings.

Robert L. Coleman is chief scientific officer at US Oncology Research .

CRISPR–Cas9 for muscular dystrophy

Simone Spuler: Muscle stem cells are the only cells that can regenerate muscle. In patients who have a genetic muscular dystrophy in which muscle wastes for genetic reasons, these stem cells carry mutations, but these mutations can now be corrected with CRISPR–Cas9 and other tools. Correcting muscle stem cells means muscle can be rebuilt, which was not been previously possible whatsoever in these muscular dystrophies.

Muscular dystrophies are a group of about 50 different diseases that lead young people and children to lose their ability to walk, or to breathe, and make them wheelchair-bound within a couple of years. We are working with corrected muscle stem cells able to rebuild muscles and we will test this in a trial called bASKet. In the bASKet trial , there are two major questions. The first is about safety. We would like to see that nothing happens to the patients that makes the disease worse, such as a gene encoding a tumor suppressor being switched on. We do all kinds of preclinical safety tests to preclude that possibility. New proteins will be made by these stem cells, which probably have not been seen by the patient’s immune system, so it could attack this foreign protein. We will inject the cells that are repaired into the patient in an autologous manner, and check a few months later to see if new muscle is built. The second question we are addressing is about clinical improvement. This is something the regulatory agencies asked us to do. We hope to have the first data a few months after we begin treating patients in June and July 2023.

Simone Spuler leads the myology research group and the Outpatient Clinic for Muscle Disorders at the Experimental and Clinical Research Center, a joint institution established by the Max Delbrück Center and the Charité–Universitätsmedizin, in Berlin, Germany .

Cervical cancer screening in the vaccinated

Karen Canfell: Prophylactic vaccines against human papilloma virus (HPV), first rolled out 15 years ago, protect women against cervical cancer and are now routinely offered to young girls in most high-income countries. As time moves on, more women who were vaccinated as girls become eligible for cervical cancer screening, and it is important to understand the most effective screening approaches in a vaccinated population. This trial is important, as it is the first large-scale randomized controlled trial internationally that will assess primary HPV screening in a population that is heavily vaccinated against HPV. The findings from the secondary randomization will assess newer approaches for managing HPV-positive women, which will be important for cervical screening programs that are transitioning to primary HPV testing. The COMPASS trial is also assessing new next-generation HPV testing platforms and technologies for triage testing, which are expected to improve the overall performance of HPV testing at a program level.

Karen Canfell is chair of the Cancer Screening and Immunisation Committee of Cancer Council Australia .

The Mediterranean diet for weight loss

Jordi Salas Salvadó: No study has ever demonstrated that weight loss and maintenance using an energy-reduced healthy diet and physical activity lowers the risk of cardiovascular disease in people who are overweight or who have obesity. The Look AHEAD trial in the USA, conducted in people with diabetes, has been discontinued owing to lack of efficacy in reducing the risk of cardiovascular events and mortality after approximately 10 years of follow-up, despite achieving significant differences between interventions in long-term weight loss.

We hypothesize that an intensive lifestyle-intervention program aimed at weight loss and based on the traditional Mediterranean diet is a sustainable long-term approach for achieving weight loss in overweight and obese adults, and that the lifestyle changes achieved will have a beneficial effect on cardiovascular morbidity and mortality.

Jordi Salas Salvadó is a Distinguished Professor of Nutrition at Rovira i Virgili University and Principal Investigator at CIBER-Obn Instituto de Salud Carlos III, Spain .

Safe treatment for sleeping sickness

Olaf Valverde: In 2023, we will receive the complete results of our clinical trial testing of a breakthrough, all-oral, safe medicine for treating the variant of sleeping sickness caused by Trypanosoma brucei rhodesiense . Also known as human African trypanosomiasis, this neglected parasitic disease transmitted by the bite of the tse tse fly causes severe neuropsychiatric disorders. In contrast to T. brucei gambiense , for which humans are considered the primary reservoir, T. brucei rhodesiense is highly zoonotic, with animals and livestock considered the primary reservoir. It is endemic in eastern and southern Africa, evolves quickly, and can kill in weeks to months if left untreated.

For decades, doctors in endemic countries had to treat sleeping sickness by using melarsoprol, an arsenic derivative so toxic that it killed 5% of patients. Our organization started developing a series of improved drugs, and in 2018 registered fexinidazole, a safe and effective first all-oral drug for the variant of the disease caused by T. brucei gambiense . But for patients with the variant caused by T. brucei rhodesiense , doctors still have to use the dreaded melarsoprol for advanced cases. This clinical trial is assessing the efficacy of fexinidazole for sleeping sickness caused by T. brucei rhodesiense , in comparison with the efficacy of the existing drugs melarsoprol and suramin. Full results will be presented to the European Medicines Agency in 2023, and we expect to get a favorable opinion.

Olaf Valverde is the clinical project leader of the human African trypanosomiasis team of the Drugs for Neglected Diseases initiative .

Circulating tumor cells

Nicola Aceto: My lab is interested in metastasis. More than 90% of people with cancer die when metastasis happens. It is a big unsolved problem. We recently found that metastasis is driven mostly by clusters of circulating tumor cells (CTCs), which are multicellular aggregates of tumor cells that depart from the existing tumor , circulate in the bloodstream , and then metastasize. This finding challenged the prevailing dogma in the metastasis field, as until a few years ago, people thought metastasis happened one cell at a time. Thanks to new technologies, we could finally investigate blood samples from patients and in animal models, which allowed us to identify CTC clusters.

We have also found that there are drugs, such as digoxin, that have the ability to dissociate these cells and dissolve the clusters, which shuts down metastasis in preclinical models. We have now set up a small phase 1 trial as a proof of mechanism. We screen the blood of patients with advanced metastatic breast cancer, and when we find CTC clusters, we give the patients the drug for 3 weeks, during which time we measure the abundance and features of the clusters. Digoxin is a well-known drug used to treat heart conditions, but it has this beautiful side effect. Should the trial be successful, we envision the generation of improved cluster-dissociating molecules, able to achieve full cluster dissolution and specifically designed to treat cancer. This is the next ambitious goal: enabling a novel cancer-treatment modality that is aimed at blocking the spread of cancer.

Nicola Aceto is an associate professor of molecular oncology at ETH Zurich .

Lecanemab for Alzheimer’s disease

Allan Levey: In 2023, I expect to see more peer-reviewed publications and data on lecanemab, an investigational monoclonal antibody to amyloid-β protofibrils, for the treatment of mild cognitive impairment with Alzheimer’s disease. The developer, Eisai, announced positive topline results from their large global phase 3 confirmatory Clarity AD clinical trial of lecanemab in late September. We saw extensive data on lecanemab at the Clinical Trials on Alzheimer’s Congress in late November and early December 2022 and a landmark publication in the New England Journal of Medicine was published on 29 November 2022.

Much data have been made available for scrutiny and independent, secondary analyses with the publication. Eisai is expected to file an application with the FDA for traditional approval in the USA and marketing-authorization applications in Japan and Europe by the end of March 2023. This is a pivotal phase 3 trial that most experts consider a huge game-changer for this field. In Alzheimer’s disease, there are no disease-modifying treatments that are clearly proven (aducanumab has been approved, despite uncertain clinical efficacy). Until recently, evidence for disease modification has been lacking, despite an industry-wide focus on amyloid-based therapies for many years.

With this new lecanemab study, the results of the phase 3 study show a significant reduction in clinical progression, confirming the results of an earlier phase 2 study. All primary and secondary endpoints, including dementia severity, cognition and functional abilities, were met. The second issue is that safety has been a huge concern with previous treatments given accelerated approval. The results for lecanemab indicate that its safety is much better, although there were adverse events. These are the reasons it is a game changer. Additional important insights will be gleaned about the magnitude and duration of benefits, and a more palatable and scalable form of subcutaneous dosing when more data and analysis are published in 2023.

Allan Levey is a professor and chair of the Department of Neurology at Emory University’s School of Medicine, and director of the Emory University Goizueta Alzheimer’s Disease Research Center .

COVID-19 vaccination and HIV

Glenda Gray: In December 2021, we began a trial to enroll almost 14,500 participants in more than 50 research clinics in eight sub-Saharan African countries. The Ubuntu multicenter phase 3 clinical trial will assess the efficacy of the mRNA-1273 (Moderna) vaccine against COVID-19 in adults infected with human immunodeficiency virus (HIV) or with other comorbidities that increase the risk of severe COVID-19. This trial will include a smaller number of HIV-negative people.

There is an urgent need to characterize infection and viral clearance in people who are immunocompromised, which will be assessed in our study . The results, which we expect in 2023, should indicate how many doses of vaccine are needed for adults living with HIV, as well as in adults with other health conditions that may put them at risk for severe COVID-19. We are also expecting data on whether people who have been infected with the coronavirus SARS-CoV-2, and therefore probably have some immunity, need as many vaccine doses as those without prior infection. We also want to know if the original Moderna vaccine is inferior to the new bivalent one, which includes the spike protein from a SARS-CoV-2 variant of concern. This direct comparison of mRNA-1273 against the bivalent vaccine should give us insight into the utility of variant-specific vaccines. We hope that when these results are published next year, they will help to refine an optimal vaccine strategy and the best regimen for HIV-infected people.

Glenda Gray is president and CEO of the South Africa Medical Research Council .

Gene editing for sickle-cell disease

Luigi Naldini: We are all waiting for the first long-term data from gene-editing strategies in sickle-cell disease and thalassemia. There have been preliminary reports of efficient editing . The key question is whether these gene grafts remain stable. We have seen very safe stable long-term grafts of stem cells treated with lentiviral vectors, and prolonged safety, but will this be the same for gene-editing tools?

We may soon be seeing the interim results in 2023 of a multi-center sickle-cell disease trial of gene editing sponsored by CRISPR Therapeutics and Vertex Pharmaceuticals. This is a single-arm, open-label, multi-site, single-dose phase 1/2/3 study in people with severe sickle-cell disease. The study is evaluating the safety and efficacy of autologous CRISPR–Cas9-modified CD34 + human hematopoietic stem and progenitor cells. Participants receive a single infusion of these cells through a central venous catheter. The top outcome of interest would be participants who have not experienced any severe vaso-occlusive crisis for at least 12 consecutive months. It will be crucial to verify the long-term stability and polyclonal composition of the graft without the emergence of adverse events. Beyond this, what we are looking forward to seeing is the first clinical testing of what we call ‘writing back’ genes; that is, correcting genetic mutations by introducing editing of longer sequences, which has not been clinically achieved yet. We and others are actively working closely on that.

Luigi Naldini is a professor of cell and tissue biology and of gene and cell therapy at the San Raffaele University School of Medicine, and scientific director of the San Raffaele Telethon Institute for Gene Therapy, Milan, Italy .

Reducing harm from prostate cancer screening

Anssi Auvinen: The evidence surrounding testing for the marker PSA (prostate-specific antigen) is full of conflict, as the test may detect prostate cancer but at the expense of treating cancers with little threat to health. We aim to detect only clinically relevant, aggressive prostate cancer while minimizing the diagnosis of clinically unimportant, low-risk cancers that would constitute over-diagnosis (meaning that they would not progress even if left undetected and untreated). A previous trial showed benefits that were comparable to those of other cancer screening programs, but we wanted to put more effort into harnessing recent developments to reduce harm, including over-diagnosis and unnecessary biopsies.

Anssi Auvinen is a professor of health sciences at Tampere University, Finland .

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Arnold, C., Webster, P. 11 clinical trials that will shape medicine in 2023. Nat Med 28 , 2444–2448 (2022).

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

An external file that holds a picture, illustration, etc.
Object name is cureus-0015-00000035077-i01.jpg

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

An external file that holds a picture, illustration, etc.
Object name is cureus-0015-00000035077-i02.jpg

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].


Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Article Contents

Background and significance, materials and methods, author contributions, supplementary material, conflict of interest, data availability, understanding enterprise data warehouses to support clinical and translational research: impact, sustainability, demand management, and accessibility.

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Thomas R Campion, Catherine K Craven, David A Dorr, Elmer V Bernstam, Boyd M Knosp, Understanding enterprise data warehouses to support clinical and translational research: impact, sustainability, demand management, and accessibility, Journal of the American Medical Informatics Association , 2024;, ocae111,

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Healthcare organizations, including Clinical and Translational Science Awards (CTSA) hubs funded by the National Institutes of Health, seek to enable secondary use of electronic health record (EHR) data through an enterprise data warehouse for research (EDW4R), but optimal approaches are unknown. In this qualitative study, our goal was to understand EDW4R impact, sustainability, demand management, and accessibility.

We engaged a convenience sample of informatics leaders from CTSA hubs ( n  = 21) for semi-structured interviews and completed a directed content analysis of interview transcripts.

EDW4R have created institutional capacity for single- and multi-center studies, democratized access to EHR data for investigators from multiple disciplines, and enabled the learning health system. Bibliometrics have been challenging due to investigator non-compliance, but one hub’s requirement to link all study protocols with funding records enabled quantifying an EDW4R’s multi-million dollar impact. Sustainability of EDW4R has relied on multiple funding sources with a general shift away from the CTSA grant toward institutional and industry support. To address EDW4R demand, institutions have expanded staff, used different governance approaches, and provided investigator self-service tools. EDW4R accessibility can benefit from improved tools incorporating user-centered design, increased data literacy among scientists, expansion of informaticians in the workforce, and growth of team science.

As investigator demand for EDW4R has increased, approaches to tracking impact, ensuring sustainability, and improving accessibility of EDW4R resources have varied.

This study adds to understanding of how informatics leaders seek to support investigators using EDW4R across the CTSA consortium and potentially elsewhere.

Healthcare organizations increasingly seek to enable secondary use of electronic health record (EHR) data for analytics and research. Toward this goal, many institutions have deployed a combination of people, process, and technology referred to as an enterprise data warehouse for research (EDW4R). 1 Through funding from the National Institutes of Health (NIH) National Center for Advancing Translational Science (NCATS), a group of 60 HCOs, or Clinical and Translational Science Awards (CTSA) program “hubs,” have almost all implemented an EDW4R. 2 , 3 However, optimal approaches to build and support EDW4R remain unknown. In prior studies, we found variation in EDW4R operations in CTSA hubs with respect to organizational and technical architecture, processes for access, and service management 4 as well as enterprise information technology (IT) relationships, data governance, workforce, and cloud computing. 5 The goal of this study was to address gaps in understanding EDW4R impact, sustainability, demand management, and accessibility.

With widespread EDW4R adoption among CTSA hubs, multiple stakeholders have pursued ever-increasing use of EDW4R resources to accelerate science. As investigators have demonstrated value of using EHR data for phenotyping patients, 6 determining cancer response, 7 and automating clinical documentation, 8 they have also characterized limitations of EHR data and developed strategies for improving data quality through imputation. 9–11 Moreover, secondary use of EHR data is challenging 12 due to cross-system record linkage, 13 standardization gaps, 14 analytical assumptions, 15 and collider bias, 16 among other factors. To support a greater number and variety of studies, including investigations using artificial intelligence and multimodal data, 17 institutions have integrated EHR data with imaging, 18 , 19 biospecimen, 20 insurance claim, 21 and genomic 22 sources. Additionally, scholars have noted EDW4R as essential for data-driven learning health systems. 23–25 To participate in multi-institutional consortia, EDW4R teams have adopted 1 or more common data models (CDMs) to represent clinical information. For example, using the PCORnet ® CDM, PCORnet ® has determined disease prevalence when combining EHR and claims data for 17 to 170 million patients. 26–28 Additionally, the NIH All of Us Research Program, which has enrolled more than 500 000 participants to provide data from EHR as well as genomic and lifestyle sources, 29 has enabled large-scale phenome-wide association studies. 30 Efforts in the Observational Health Data Sciences and Informatics (OHDSI) consortium as well as the NIH National COVID Cohort Collaborative (N3C) have continued to advance standardized vocabularies 31 and data quality, 32 respectively, while the NIH Researching COVID to Enhance Recovery (RECOVER) initiative has demonstrated benefits of an open science approach for machine learning with EHR data. 33 In industry, at least 1 drug company has described efforts to address challenges in generating real world evidence from EHR data, 34 and the TriNetX network connecting healthcare organizations’ EHR data with pharmaceutical sponsors has continued to grow in size of participants and scope of activities. 35 Despite widespread EDW4R adoption among CTSA hubs and expanded use of EDW4R data by multiple stakeholders, optimal approaches for EDW4R operation remain unknown, which hinders resource allocation within individual hubs and across the CTSA consortium.

In prior work, we identified areas that needed further study including EDW4R impact, sustainability, demand management, and accessibility. Impact describes how investigators apply EDW4R to scientific processes, how institutions measure EDW4R, 36 and how investigator use of EDW4R affects institutional activities. 37 Impact includes types of research benefitting from EDW4R as well as metrics of interest to IT and research leadership.

Sustainability refers to how institutions support EDW4R activities over time. Long a topic of discussion among CTSA hubs, 38 , 39 funding for research informatics, 40 and EDW4R especially, 3 continues to evolve through combinations of financial sources, collaborations with enterprise IT organizations, and other mechanisms. 5

Demand management addresses how EDW4R teams respond to requests for patient data and usage of resources. Delivery of data occurs through multiple modalities, including analyst-mediated custom reports and investigator self-service of tools like i2b2. 4 In addition to technical solutions, demand management addresses allocation of resources through governance, prioritization, and education. 41 , 42

Accessibility encompasses ideal EDW4R user experience and opportunities to make tools easier for informaticians and non-informaticians to use EDW4R resources. In addition to technology elements such as modern query tools 43 and user interface design, 44 accessibility includes social elements such as service delivery 45 and data literacy. 46

To foster development of best practices for secondary use of data from EHR and other sources for research, the CTSA consortium’s Informatics Enterprise Committee (iEC) formed the Enterprise Data Warehouse for Research Working Group (EDW4R WG) with leadership from 2 co-authors (B.M.K. and T.R.C.). The EDW4R WG collaborated with the NCATS National Center for Data to Health (CD2H), and 1 co-author (D.A.D.) functioned as a liaison between the groups. The University of Iowa Institutional Review Board (IRB) determined this study to be non-human subject research.

Data collection

We engaged a convenience sample of informatics leaders ( n  = 23) from CTSA hubs ( n  = 21) for semi-structured interviews conducted via Zoom between January and November 2022. Informed by previous work, EDW4R WG discussion, and recommendations from the CTSA Steering Committee, a guide developed by 2 co-authors (B.M.K. and T.R.C.) facilitated interviews ( Appendix S1 ). Notably, the CTSA Steering Committee defined interview questions about EDW4R accessibility, specifically ideal user experience and opportunities for new tools. During sessions with participants, 2 interviewers (B.M.K. and T.R.C.) recorded notes electronically or on paper with subsequent transcription into electronic form.

Data analysis

The study team completed a directed content analysis 47 of interview transcripts. After 2 co-authors (B.M.K. and T.R.C.) labeled concepts and relationships, peer debriefing 48 occurred with 3 co-authors (C.K.C., D.A.D., and E.V.B.), who were not involved in conducting the interviews but were experts in EDW4R, reviewing initial findings. Feedback from peer debriefing refined analysis of concepts and relationships further; 2 co-authors (B.M.K. and T.R.C.) then presented the refined analysis to EDW4R WG monthly meeting attendees, which included some interview participants, as part of member checking. Feedback from member checking further refined and validated findings.

We transcribed over 50 pages of text from interviews with 23 participants from 21 CTSA hubs conducted across almost 30 hours. Two interviews included 2 respondents from the same hub to clarify and expand comments as necessary; responses from the same hub accorded rather than conflicted with each other. Table 1 describes characteristics of participants.

Characteristics of participants.

In characterizing EDW4R impact, 7 hubs described using EHR data to support 2 primary scientific workflows: identification of potential participants for prospective studies and data extraction for retrospective observational studies; 2 other hubs stated investigators used EDW4R only to support participant identification for prospective studies. Additionally, 5 hubs indicated EDW4R enabled institutional participation in national data consortia, such as PCORnet, OHDSI, and the National COVID Cohort Collaborative (N3C) among others. Four hubs indicated EDW4R “democratized” or enabled easier EHR data access for researchers from multiple medical school departments as well as across other colleges, including business, engineering, and arts and sciences. Hubs also indicated that EDW4R supported major institutional programs, including COVID response ( n  = 3) and National Cancer Institute Cancer Center designation ( n  = 2). Two hubs highlighted learning health system projects with data-driven patient care workflows as evidence of EDW4R impact.

For measuring EDW4R impact, participants noted challenges with tracking publications that used EDW4R ( n  = 7), especially due to investigator non-compliance citing CTSA grant support ( n  = 4). At least 3 hubs described indirect impact where investigators “just disappear” following, for example, initial consultation with EDW4R staff for clinical trial eligibility determination. In contrast to EDW4R, 1 participant noted that measurement of high-performance computing usage and impact was straightforward, as study teams worked directly with informatics staff on projects. One hub described an institutional requirement to associate each IRB-approved study protocol with 1 or more grant records, which, because the intake process required specification of a study protocol, enabled quantifying the EDW4R’s multi-million dollar impact on the biomedical research enterprise.

Regarding measures of EDW4R impact, participants described research leadership as focused on traditional metrics of academic productivity such as grants and papers ( n  = 7) and salary support of faculty and staff ( n  = 2). Although at least 3 hubs conducted annual surveys of faculty to understand EDW4R impact, 1 hub indicated the success rate of investigators pursuing grant funding using EDW4R resources was unknown and likely low. Of interest to IT leadership were few complaints from faculty ( n  = 2) as well as “burger-flipping metrics” such as number of data deliveries, users, and queries ( n  = 5). Notably, 1 hub described IT leadership finding value in EDW4R removing research requests from the workload of clinical IT, thus freeing capacity to support clinical operations and quality reporting. At least 3 hubs described EDW4R team growth as a measure of impact, and only 1 hub used a validated framework 49 to measure impact.

Four hubs indicated institutional leaders and investigators recognized that EDW4R achieved economies of scale. Three hubs described a measure of EDW4R success as effectively incentivizing investigators to use centralized resources rather than invest in separate analytics infrastructure. As 1 respondent noted, a hub must “[push] researchers to spend money in the right way rather than in a free-for-all fashion” so that, as another respondent indicated, “…people use the centralized [EDW4R] tools and don’t go wandering off on their own,” which increases inefficiency and risk of privacy breaches. For 1 hub, a small EDW4R team that “punch[ed] above [its] weight” and demonstrated “pragmatic excellence” justified an institutional request for additional resources.

Two hubs also described a potential shift in approach by institutional leadership in measuring EDW4R impact. A respondent from an exceptionally mature hub as noted in EDW4R WG discussions stated, “The assumption at the institution is that researchers will demonstrate value through outcomes, which leads to lowering of interest in monitoring activities. Instead of process we’re focusing on [measuring grants and high-impact publications enabled by the EDW4R].” Another respondent indicated, “Trying to measure impact is a little like measuring impact of HVAC (heating, ventilation, and air conditioning) on research,” suggesting measurement of EDW4R is challenging and unnecessary while benefit is understood and a taken-for-granted assumption of organizational life.


Respondents described a mix of funding from CTSA hub, medical school, health system, investigator grant, and industry sources. Participants noted a shift away from CTSA grant funding as the main source with 4 hubs describing increased dependence on institutional support. Two hubs independently described a funding structure consisting of 40% health system, 40% grants, and 20% industry. Notably, the hubs described industry funding as addressing technology infrastructure costs but cautioned against higher levels of commercial funding to ensure EDW4R activities remained aligned with the CTSA hub mission. An example of an industry-funded project described by a respondent involved using the EDW4R to generate real world evidence from EHR data. Two hubs described institutional investment for EDW4R with the expectation of cost recovery from grants.

Chargebacks were common cost recovery approaches for EDW4R teams with most hubs ( n  = 15) indicating investigators were receptive to paying them. As 1 respondent indicated, “Nothing is free [to investigators]; some things are subsidized.” At least 2 hubs reported investigators being more willing to allocate grant funding to CTSA informatics faculty rather than staff despite faculty being more expensive. One hub indicated that request delivery time was a greater concern among investigators than cost. At a hub recognized as an exemplar in EDW4R WG discussions, a respondent noted that increasing staff was not a scalable solution, as faculty absorbed all staff capacity. Instead, the hub posited long-term sustainability as requiring improved informatics tools to empower researchers.

Regarding perceptions of costs from leadership, participant responses ranged from supportive ( n  = 2) and acceptable for now ( n  = 2) to actively seeking cost reductions ( n  = 3) to “no news is good news” ( n  = 6). A major cost was staffing with 1 hub noting, “Money is not the problem; hiring people is the problem,” and another hub employing undergraduate students to deliver EDW4R data for investigator requests. In 1 hub, finance leadership sought for EDW4R staff to track time in 20-minute increments to enable more granular cost accounting, which caused EDW4R leadership to push back against the proposal to not burden staff and cause them to seek employment elsewhere.

Demand management

Nearly all hubs ( n  = 19) reported an increase in demand for EDW4R services over time, especially during the COVID-19 pandemic. Over 15 years, 1 hub reported scaling support from 150 to 6000 data requests per year. To address increased demand, multiple hubs ( n  = 6) reported hiring additional staff. However, as 1 respondent indicated, “Our users doubled and tickets tripled, but our budget and team have not tripled, and our institution is not twice as successful in getting grants.” Hubs ( n  = 6) also reported increasingly supporting investigators with self-service tools, such as TriNetX, i2b2, ATLAS, Epic SlicerDicer, and homegrown solutions. However, 3 hubs noted a need to increase data literacy among investigators using self-service tools, including how data in query tools relate to front-end EHR displays. As 1 respondent indicated, “[Investigators] don’t want data; they want answers.”

Prioritization of data requests proved challenging with teams employing a modified first-in-first-out (FIFO) approach with grant funding, alignment with clinical objectives, and investigator relationships expediting particular activities at the expense of others ( n  = 7); 2 of the approaches assigned points to requests for ranking and fulfillment. Two respondents expressed concern that prioritization approaches blocked unfunded junior faculty from obtaining resources and developing as scientists.

Governance approaches varied with 5 hubs describing institution-wide oversight committees and 3 describing decision-making by EDW4R leadership. Hubs pursuing multi-stakeholder governance described benefits such as limiting investigator influence in resource allocation decisions ( n  = 1) and separating EDW4R project prioritization from data request fulfillment ( n  = 2) as well as challenges in aligning different interests ( n  = 4). As 1 respondent indicated, “It is difficult to get consensus from researchers. They’re not thinking at a meta-level. They’re thinking about, ‘What’s my project and how do I get it done?’ That’s why they’re great at science. But you can’t get them together and [have them determine how to comprehensively meet the needs of researchers across the institution].” Citing overhead of managing complex relationships, 3 hubs relied on an EDW4R executive, such as a chief research information officer (CRIO), for governance decisions.

Accessibility: ideal user experience

Regarding the ideal user experience for EDW4R, respondents described multiple investigator personas requiring different solutions. One respondent distinguished between 2 types of investigators, “those who can do statistics and code versus those who cannot,” while others characterized distinct needs of clinical trialists, health services researchers, and data scientists. As 2 respondents indicated, EDW4R platforms need to clearly state to investigators the skills required for use.

For clinical trialists and other less technically facile researchers, 2 hubs described the ideal experience as being similar to a Google search, whereby an investigator can provide natural language terms for clinical data without needing programming skills or controlled vocabulary knowledge. Four hubs described a user experience wherein features of tools help improve data literacy for investigators. As 1 respondent indicated, systems should “…present not only data but context of data, exposing quality of data and true meaning of the vocabularies and models” to scientists.

Several hubs ( n  = 9) described TriNetX as valuable for self-service access for investigators new to using EHR data for research. Respondents characterized TriNetX’s user interface as “clean, modern, and intuitive,” “the best example of how to make [self-service EHR data query] platforms easier” to use, and helpful for improving investigator data literacy. One hub indicated that the TriNetX experience could improve through implementation of alerts to guide investigator behavior in building queries (eg, use temporal relationships). While describing value of TriNetX, 1 respondent also expressed concern about the tradeoff between ease of use of the platform and reliance on a private company.

For technically facile investigators such as health services researchers and data scientists, respondents ( n  = 4) characterized ideal user experience as involving access to computational resources and documentation about data, including source system lineage, mappings to common data models (eg, OMOP), and pre-configured sets of clinical concepts (eg, diabetes diagnosis codes and laboratory results). Four hubs described investigators interacting with EDW4R data through a secure institutional enclave with compute capacity, analytical software (ie, R, SAS, Python), and approved datasets ( n  = 3), thereby obviating need for EDW4R teams to distribute spreadsheets containing EHR data extracts via email. Two hubs described institution-specific EDW4R infrastructure as limiting science, with 1 hub advocating for a centralized EDW4R shared across the CTSA consortium similar to N3C and another hub suggesting adoption of common infrastructure and containerized workflows to enable collaboration without transferring data across institutional boundaries. To foster development of technical skills necessary to use sophisticated data resources, 2 hubs highlighted value of clinician investigators conveying to other physician scientists success stories of learning and applying statistics and programming “in their own words” rather than as shared by informaticians.

Regardless of an investigator’s technical skills, several hubs ( n  = 9) characterized ideal EDW4R user experience as involving team science or engagement between investigator, informatician, and biostatistician. Emphasizing value of multidisciplinary collaboration, 1 respondent indicated, “Data scientists don’t have all the answers. There is a gap between data insights and clinical insights. Converging these two is key.” As 1 respondent indicated, “Investigators think about a spreadsheet with 400 columns [representing different clinical variables], but the EDW4R is different” and requires developing common understanding between data requesters and providers. Multiple respondents stated that informaticians are well-positioned as the bridge between researcher and EDW4R for thoughtful interrogation of data. One participant described value of an informatics professional “[who] is available quickly, understands the problem quickly, and is able to deliver data in a timely and affordable fashion” to enable a study team to generate a grant proposal or publication. As another respondent indicated, informatics professionals help investigators “understand what one can request, feel respected and empowered, and learn bad news and good news, including things [informatics professionals] can help with that they didn’t know.” Another hub described a goal of having biostatistics and epidemiology staff extract data from an EDW4R so informatics staff can focus on more complex activities, such as deepening expertise of source system data.

Accessibility: opportunities for tools

To improve EDW4R accessibility for informaticians and non-informaticians, respondents described opportunities to incorporate user-centered design into platforms ( n  = 4). One respondent noted for-profit companies such as TriNetX have invested in user interface and user experience while CTSA hubs have not. Another respondent characterized EDW4R tooling as “functionally motivated, not focused on human experience…built by engineers for engineers.” Two respondents described human–computer interaction as a scientific discipline that the EDW4R community should embrace to improve user experience.

Regarding whether improved EDW4R tools represent the largest need for non-informaticians, respondents almost equally agreed ( n  = 5), partially agreed ( n  = 6), and disagreed ( n  = 6). Respondents agreeing indicated new tools were necessary to overcome human–computer interaction barriers, unsolved problems of clinical information extraction and representation, and a lack of informaticians to engage with study teams. As 1 respondent stated, “We are completely slammed with non-informatics community users. It’s amazing how much time is spent trying to help people help themselves…Without a way to empower non-informaticians, we will not be able to scale to keep up with demand.”

Those partially agreeing that EDW4R tools are the biggest gap for non-informaticians described a need to balance new tool development with expansions in researcher training, data engineering, and financial support. As 1 respondent indicated, “There are a lot of unsexy things in data work that are expensive that no one talks about” critical to EDW4R success. Participants disagreeing that EDW4R tools are the greatest barrier for non-informaticians described greater needs for thoughtful interrogation of EHR data, data literacy among non-informaticians, skilled informaticians, team science, and grant support for informatics effort. As 1 respondent stated, “The biggest bottleneck is getting people used to working with data and doing biostatistics and data science…Not solving [the problem] for data-savvy people and instead racing toward solving for non-informaticians is [a] huge [change in the wrong direction].” Two hubs expressed that funders should require involvement of informaticians as key personnel in grants as is customary of biostatisticians. By increasing availability of data without commensurate improvements in data understanding, 2 hubs cautioned that data interpretation and use could lead to danger. As 1 respondent indicated, “With an increase of data literacy across the enterprise, we have hope.”

In this qualitative study, informatics leaders from 21 CTSA hubs described approaches to understanding impact, ensuring sustainability, managing demand, and improving accessibility of EDW4R resources. The findings suggest emergence of markers of maturity and potential best practices as well as challenges in sustainability and opportunities for optimizing tools and teams.

Two observations of impact may be markers of maturity of EDW4R operations. 1 First, mature organizations appeared to shift measurement activities from EDW4R teams’ “burger-flipping” volume metrics 4 to researchers’ scholarly output and funding. Hubs where stakeholders recognize EDW4R as integral to scientific outcomes may be more mature. Second, investing in centralized EDW4R rather than standalone efforts, thus realizing economies of scale in EDW4R activities, may indicate maturity. EDW4R organization depends on “[t]he relationship between a CTSA hub and its [affiliated clinical enterprise(s)],” 4 and distinction between research and operational EHR data needs requires an institution to engage investigators with a more versatile workforce. 5 Centralization of EDW4R appears to yield efficiency.

For measuring impact of EDW4R, 1 hub’s institutional requirement for investigators to link all study protocols with funding records (ie, grants, contracts, institutional support) may represent a best practice for other institutions to adopt. Widespread implementation may enable EDW4R teams and the CTSA consortium to track funding of activities supported rather than rely on bibliometrics, which remains a challenge for hubs. As observed in nearly 2 decades of scholarship 3 , 39 , 40 and the current study, EDW4R sustainability remains a major barrier for CTSA hubs, and institutional support appears critical. 4 , 5 Notably, 2 hubs independently reported a goal of achieving support through 40% institutional, 40% extramural award, and 20% industry sources, an approach that other hubs may wish to pursue and could become a best practice.

Access to EDW4R services tailored to different types of investigators emerged as a common goal among hubs, all of which have observed demand for EDW4R services outpace capacity. To support non-informaticians, some hubs characterized a “Google-like search” of EHR data, which large language models (LLMs) with prompts may help address. 50 Respondents also recommended providing guidance to investigators within tools regarding data context and query strategies, which a solution based on InfoButtons could address. 51 Ultimately, however, workforce expansion 5 and team science appear crucial for success. Bringing together clinicians, biostatisticians, and informaticians who understand the strengths and limitations of EHR data and research design along with better tools may represent a tripartite solution for the CTSA consortium to achieve.

Limitations of this study require consideration. First, the convenience sample of 21 CTSA hubs represents neither all CTSA hubs nor all healthcare organizations. However, prior qualitative EDW4R studies 4 , 5 informed quantitative survey activities of CTSA hubs, 1 which future work can similarly address. Second, to protect privacy of participants, we omitted details related to respondents’ role seniority and presented context from interviews, verified through the EDW4R WG meeting series, using relative terms like “exceptionally mature hub,” which future qualitative and quantitative studies may address. Third, we conducted interviews prior to widespread adoption of LLM-based approaches that may affect user experience for engaging with EDW4R resources. Future studies can investigate EDW4R user-experience through use of emerging technologies.

Clinical and translational scientists increasingly rely on EDW4R services, and CTSA hubs need to responsibly allocate resources in a changing landscape. Although non-academic healthcare organizations differ in focus from CTSA hubs and other academic settings, all healthcare organizations consist of stakeholders from clinical, legal, privacy, IT, analytics, and other units that may seek to engage in secondary use of EHR data. Understanding how institutions across the CTSA consortium operate EDW4R can inform how CTSA hubs and other entities deliver critical data infrastructure.

This qualitative study of EDW4R operations adds to understanding of how informatics leaders seek to meet investigator needs for EHR data across the CTSA consortium. Scholars and practitioners may find findings valuable for measurement and operation of EDW4R infrastructure.

Boyd M. Knosp and Thomas R. Campion conceptualized the study and interview guide, conducted interviews, transcribed notes, and performed analysis. CTSA Steering Committee members provided guidance on accessibility questions in the interview guide. Catherine K. Craven, David A. Dorr, and Elmer V. Bernstam provided iterative interview guide and analytical feedback. Thomas R. Campion wrote the manuscript with contributions from Boyd M. Knosp. Catherine K. Craven, David A. Dorr, and Elmer V. Bernstam edited the manuscript. Thomas R. Campion and Boyd M. Knosp revised the manuscript.

Supplementary material is available at Journal of the American Medical Informatics Association online.

This study received support from the National Institutes of Health National Center for Advancing Translational Sciences through grant numbers UL1TR 002537 (Iowa), 000457 (Weill Cornell), 002369 (OHSU), and 003167 (UTHSCH).

The authors have no competing interests to report.

The data underlying this article will be shared on reasonable request to the corresponding author.

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  • Published: 24 May 2024

Integration of case-based learning and three-dimensional printing for tetralogy of fallot instruction in clinical medical undergraduates: a randomized controlled trial

  • Jian Zhao 1   na1 ,
  • Xin Gong 1   na1 ,
  • Jian Ding 1 ,
  • Kepin Xiong 2 ,
  • Kangle Zhuang 3 ,
  • Rui Huang 1 ,
  • Shu Li 4 &
  • Huachun Miao 1  

BMC Medical Education volume  24 , Article number:  571 ( 2024 ) Cite this article

Metrics details

Case-based learning (CBL) methods have gained prominence in medical education, proving especially effective for preclinical training in undergraduate medical education. Tetralogy of Fallot (TOF) is a congenital heart disease characterized by four malformations, presenting a challenge in medical education due to the complexity of its anatomical pathology. Three-dimensional printing (3DP), generating physical replicas from data, offers a valuable tool for illustrating intricate anatomical structures and spatial relationships in the classroom. This study explores the integration of 3DP with CBL teaching for clinical medical undergraduates.

Sixty senior clinical medical undergraduates were randomly assigned to the CBL group and the CBL-3DP group. Computed tomography imaging data from a typical TOF case were exported, processed, and utilized to create four TOF models with a color 3D printer. The CBL group employed CBL teaching methods, while the CBL-3DP group combined CBL with 3D-printed models. Post-class exams and questionnaires assessed the teaching effectiveness of both groups.

The CBL-3DP group exhibited improved performance in post-class examinations, particularly in pathological anatomy and TOF imaging data analysis ( P  < 0.05). Questionnaire responses from the CBL-3DP group indicated enhanced satisfaction with teaching mode, promotion of diagnostic skills, bolstering of self-assurance in managing TOF cases, and cultivation of critical thinking and clinical reasoning abilities ( P  < 0.05). These findings underscore the potential of 3D printed models to augment the effectiveness of CBL, aiding students in mastering instructional content and bolstering their interest and self-confidence in learning.

The fusion of CBL with 3D printing models is feasible and effective in TOF instruction to clinical medical undergraduates, and worthy of popularization and application in medical education, especially for courses involving intricate anatomical components.

Peer Review reports

Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease(CHD) [ 1 ]. Characterized by four structural anomalies: ventricular septal defect (VSD), pulmonary stenosis (PS), right ventricular hypertrophy (RVH), and overriding aorta (OA), TOF is a focal point and challenge in medical education. Understanding anatomical spatial structures is pivotal for learning and mastering TOF [ 2 ]. Given the constraints of course duration, medical school educators aim to provide students with a comprehensive and intuitive understanding of the disease within a limited timeframe [ 3 ].

The case-based learning (CBL) teaching model incorporates a case-based instructional approach that emphasizes typical clinical cases as a guide in student-centered and teacher-facilitated group discussions [ 4 ]. The CBL instructional methods have garnered widespread attention in medical education as they are particularly appropriate for preclinical training in undergraduate medical education [ 5 , 6 ]. The collection of case data, including medical records and examination results, is essential for case construction [ 7 ]. The anatomical and hemodynamic consequences of TOF can be determined using ultrasonography, computed tomography (CT), and magnetic resonance imaging techniques. However, understanding the anatomical structures from imaging data is a slow and challenging psychological reconstruction process for undergraduate medical students [ 8 ]. Three-dimensional (3D) visualization is valuable for depicting anatomical structures [ 9 ]. 3D printing (3DP), which creates physical replicas based on data, facilitates the demonstration of complex anatomical structures and spatial relationships in the classroom [ 10 ].

During the classroom session, 3D-printed models offer a convenient means for hands-on demonstration and communication, similar to facing a patient, enhancing the efficiency and specificity of intra-team communication and discussion [ 11 ]. In this study, we printed TOF models based on case imaging data, integrated them into CBL teaching, and assessed the effectiveness of classroom instruction.

Research participants

The study employed a prospective, randomized controlled design which received approval from the institutional ethics committee. Senior undergraduate students majoring in clinical medicine at Wannan Medical College were recruited for participation based on predefined inclusion criteria. The researchers implemented recruitment according to the recruitment criteria by contacting the class leaders of the target classes they had previously taught. Notably, these students were in their third year of medical education, with anticipation of progressing to clinical courses in the fourth year, encompassing Internal Medicine, Surgery, Obstetrics, Gynecology, and Pediatrics. Inclusion criteria for participants encompassed the following: (1) proficient communication and comprehension abilities, (2) consistent attendance without absenteeism or truancy, (3) absence of failing grades in prior examinations, and (4) capability to conscientiously fulfill assigned learning tasks. Exclusion criteria were (1) absence from lectures, (2) failure to complete pre-and post-tests, and (3) inadequate completion of questionnaires. For their participation in the study, Students were provided access to the e-book “Localized Anatomy,” authored by the investigators, as an incentive for their participation. Voluntary and anonymous participation was emphasized, with participants retaining the right to withdraw from the study at any time without providing a reason.

The study was conducted between May 1st, 2023, and June 30, 2023, from recruitment to completion of data collection. Drawing upon insights gained from a previous analogous investigation which yielded an effect size of 0.95 [ 10 ]. Sample size was computed, guided by a statistical consultant, with the aim of 0.85 power value, predicated on an effect size of 0.8 and a margin of error set at 0.05. A minimum of 30 participants per group was calculated using G*Power software (latest ver.; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany), resulting in the recruitment of a total of 60 undergraduate students. Each participant was assigned an identification number, with codes placed in boxes. Codes drawn from the boxes determined allocation to either the CBL group or the CBL-3DP group. Subsequently, participants were randomly assigned to either the CBL group, receiving instruction utilizing the CBL methodology, or the CBL-3DP group, which received instruction integrating both CBL and 3D Printed models.

Printing of TOF models

Figure  1 A shows the printing flowchart of the TOF models. A typical TOF case was collected from the Yijishan Hospital of Wannan Medical College. The CT angiography imaging data of the case was exported. Mimics Research 20.0 software (Mimics Innovation Suite version 20, Materialize, Belgium) was used for data processing. The cardiovascular module of the CT-Heart tool was employed to adjust the threshold range, independently obtain the cardiac chambers and vessels, post-process the chambers and vessels to generate a hollow blood pool, and merge it with the myocardial volume to construct a complete heart model. The file was imported into Magics 24.0 software (version 24.0; Materialize, Belgium) for correction using the Shell tool page. After repairs, the model entered the smoothing page, where tools such as triangular surface simplification, local smoothing, refinement and smoothing, subdivision of components, and mesh painting were utilized to achieve varying degrees of smoothness. Finally, optimized data were obtained and exported as stereolithography (STL) files. An experienced cardiothoracic surgeon validated the anatomical accuracy of the digital model.

The STL files were imported into a 3D printer (J401Pro; Sailner 3D Technology, China) for model printing. This printer can produce full-color medical models using different materials. The models were fabricated using two distinct materials: rigid and flexible. Both materials are suitable for the observational discussion of the teaching objectives outlined in our study. From the perspective of observing pathological changes in the TOF, there is no significant difference between the two materials.

figure 1

Experimental flow chart of this study. A TOF model printing flow chart. B The instructional framework

Teaching implementation

Figure  1 B illustrates the instructional framework employed in this study. One week preceding the class session, all the students were tasked with a 30-minute self-study session, focusing on the theoretical content related to TOF as outlined in the Pediatrics and Surgery textbooks, along with a review of pertinent academic literature. Both groups received co-supervision from two basic medicine lecturers boasting over a decade of teaching experience, alongside a senior cardiothoracic surgeon. Teaching conditions remained consistent across groups, encompassing uniform assessment criteria and adherence to predefined teaching time frames, all conducted in a Project-Based Learning (PBL) classroom at Wannan Medical College. Additionally, a pre-course examination was administered to gauge students’ preparedness for self-study.

In adherence to the curriculum guidelines, the teaching objectives aimed to empower students to master TOF’s clinical manifestations, diagnostic modalities, and differential diagnoses, while acquainting them with treatment principles and surgical methodologies. Additionally, the objectives sought to cultivate students’ clinical reasoning abilities and problem-solving skills. the duration of instruction for the TOF theory session was standardized to 25 min. The didactic content was integrated with the TOF case study to construct a coherent pedagogical structure.

During the instructional session, both groups underwent teaching utilizing the CBL methodology. Clinical manifestations and case details of TOF cases were presented to stimulate students’ interest and curiosity. Subsequently, the theory of TOF, including its etiology, pathogenesis, pathologic anatomy, clinical manifestations, diagnostic methods, and therapeutic interventions, was briefly elucidated. Emphasis was then placed on the case, wherein selected typical TOF cases were explained, guiding students in analysis and discussion. Students were organized into four teams under the instructors’ supervision, fostering cooperative learning and communication, thereby deepening their understanding of the disease through continuous inquiry and exploration (Fig.  2 L). In the routinely equipped PBL classroom with standard heart models (Fig.  2 J, K), all students had prior exposure to human anatomy and were familiar with these models. Both groups were provided with four standard heart models for reference, while the CBL-3DP group received additional four 3D-printed models depicting TOF anomalies, enriching their learning experience (Fig.  2 D, G). After the lesson, summarization, and feedback sessions were conducted to consolidate group discussions’ outcomes, evaluate teaching effectiveness, and assess learning outcomes.

figure 2

Heart models utilized in instructional sessions. A External perspective of 3D digital models. B, C Cross-sectional views following trans-septal sagittal dissection of the 3D digital model (PS: Pulmonary Stenosis; OA: Overriding Aorta; VSD: Ventricular Septal Defect; RVH: Right Ventricular Hypertrophy). D External depiction of rigid 3D printed model. E, F Sagittal sections of the rigid 3D printed model. G External portrayal of flexible 3D printed model. H, I Sagittal sections of the flexible 3D printed model. J, K The normal heart model employed in the instruction of the CBL group. L Ongoing classroom session

Teaching effectiveness assessment

Following the instructional session, participants from the two groups underwent a theoretical examination to assess their comprehension of the taught material. This assessment covered domains such as pathological anatomy, clinical manifestations, imaging data interpretation, diagnosis, and treatment relevant to TOF. Additionally, structured questionnaires were administered to evaluate the efficacy of the pedagogical approach employed. The questionnaire consisted of six questions designed to gauge participants’ understanding of the teaching content, enhancement of diagnostic skills, cultivation of critical thinking and clinical reasoning abilities, bolstering of confidence in managing TOF cases, satisfaction with the teaching mode, and satisfaction with the CBL methodology.

The questionnaire employed a 5-point Likert scale to gauge responses, with 5 indicating “strongly satisfied/agree,” 4 for “satisfied/agree,” 3 denoting “neutral,” 2 reflecting “dissatisfied/disagree,” and 1 indicating “strongly dissatisfied/disagree.” It comprised six questions, with the initial two probing participants’ knowledge acquisition, questions 3 and 4 exploring satisfaction regarding enhanced competence, and the final two assessing satisfaction with teaching methods and modes. Additionally, participants were encouraged to provide suggestions at the end of the questionnaire. To ensure the questionnaire’s validity, five esteemed lecturers in basic medical sciences with more than 10 years of experience verified its content and assessed its Content Validity Ratio and Content Validity Index to ensure alignment with the study’s objectives.

Statistical analysis

Statistical analyses were conducted utilizing GraphPad Prism 9.0 software. Aggregate score data for both groups were presented as mean ± standard deviation (x ± s). The gender comparisons were analyzed with the chi-square (χ2) test, while the other variables were compared using the Mann-Whitney U test. The threshold for determining statistical significance was set at P  < 0.05.

Three-dimensional printing models

After configuring the structural colors of each component (Fig.  2 A, B, C), we printed four color TOF models using both rigid and flexible materials, resulting in four life-sized TOF models. Two color TOF models were created using rigid materials (Fig.  2 D, E, F). These models, exhibiting resistance to deformation, and with a firm texture, smooth and glossy surface, and good transparency, allowing visibility of the internal structures, were deemed conducive to teaching and observation. We also fabricated two color TOF models using flexible materials (Fig.  2 G, H, I), characterized by soft texture, opacity, and deformability, allowing for easy manipulation and cutting. It has potential utility beyond observational purposes. It can serve as a valuable tool for simulating surgical interventions and may be employed to create tomographic anatomical specimens. In this study, both material models were suitable for observation in the classroom. The participants were able to discern the four pathological changes characteristic of TOF from surface examination or cross-sectional analysis.

Baseline characteristics of the students

In total, 60 students were included in this study. The CBL group comprised 30 students (14 males and 16 females), with an average age of (21.20 ± 0.76) years. The CBL-3DP group consisted of 30 students (17 males and 13 females) with an average age of 20.96 years. All the students completed the study procedures. There were no significant differences in age, sex ratio, or pre-class exam scores between the two groups ( P  > 0.05), indicating that the baseline scores between the two groups were comparable (Table  1 ).

Theoretical examination results

All students completed the research procedures as planned. The post-class theoretical examination encompassed assessment of pathological anatomy, clinical presentations, imaging data interpretation, diagnosis, and treatment pertinent to TOF. Notably, no statistically significant disparities were observed in the scores on clinical manifestations, diagnosis and treatment components between the cohorts, as delineated in Table  2 . Conversely, discernible distinctions were evident whereby the CBL-3DP group outperformed the CBL group notably in pathological anatomy, imaging data interpretation, and overall aggregate scores ( P  < 0.05).

Results of the questionnaires

All the 60 participants submitted the questionnaire. Comparing the CBL and CBL-3DP groups, the scores from the CBL-3DP group showed significant improvements in many areas. This included satisfaction with the teaching mode, promotion of diagnostic skills, bolstering of self-assurance in managing TOF cases, and cultivation of critical thinking and clinical reasoning abilities (Fig.  3 B, C, D, E). All of which improved significantly ( P  < 0.05 for the first aspects and P  < 0.01 for the rest). However, the two groups were not comparable ( P  > 0.05) in terms of understanding of the teaching content and Satisfaction with the CBL methodology (Fig.  3 A, F).

Upon completion of the questionnaires, participants were invited to proffer recommendations. Notably, in the CBL group, seven students expressed challenges in comprehending TOF and indicated a need for additional time for consolidation to enhance understanding. Conversely, within the CBL-3DP group, twelve students advocated for the augmentation of model repertoire and the expansion of disease-related data collection to bolster pedagogical efficacy across other didactic domains.

figure 3

Five-point Likert scores of students’ attitudes in CBL ( n  = 30) and CBL-3DP ( n  = 30) groups. A Understanding of teaching content. B Promotion of diagnostic skills. C Cultivation of critical thinking and clinical reasoning abilities. D Bolstering of self-assurance in managing TOF cases. E Satisfaction with the teaching mode. F Satisfaction with the CBL methodology. ns No significant difference, * p  < 0.05, ** p  < 0.01, *** p  < 0.001

TOF presents a significant challenge in clinical practice, necessitating a comprehensive understanding for effective diagnosis and treatment [ 12 ]. Traditional teaching methods in medical schools have relied on conventional resources such as textbooks, 2D illustrations, cadaver dissections, and radiographic materials to impart knowledge about complex conditions like TOF [ 13 ]. However, the limitations of these methods in fully engaging students and bridging the gap between theoretical knowledge and practical application have prompted a need for innovative instructional approaches.

CBL has emerged as a valuable tool in medical education, offering students opportunities to engage with authentic clinical cases through group discussions and inquiry-based learning [ 14 ]. By actively involving students in problem-solving and decision-making processes, CBL facilitates the application of theoretical knowledge to real-world scenarios, thus better-preparing students for future clinical practice [ 15 ]. Our investigation revealed that both groups of students exhibited comparable levels of satisfaction with the CBL methodology, devoid of discernible disparities.

CHD presents a formidable challenge due to the intricate nature of anatomical anomalies, the diverse spectrum of conditions, and individual variations [ 16 ]. Utilizing 3D-printed physical models, derived from patient imaging data, can significantly enhance comprehension of complex anatomical structures [ 17 ]. These models have proven invaluable in guiding surgical planning, providing training for junior or inexperienced pediatric residents, and educating healthcare professionals and parents of patients [ 18 ]. Studies indicate that as much as 50% of pediatric surgical decisions can be influenced by the insights gained from 3D printed models [ 19 ]. By providing tangible, anatomically accurate models, 3D printing offers a unique opportunity for people to visualize complex structures and enhance their understanding of anatomical intricacies. Our study utilized full-color, to-scale 3D printed models to illustrate the structural abnormalities associated with TOF, thereby enriching classroom sessions and facilitating a deeper comprehension of the condition.

Comparative analysis between the CBL-3DP group and the CBL group revealed significant improvements in post-test performance, particularly in pathological anatomy and imaging data interpretation. Additionally, questionnaire responses indicated higher levels of satisfaction and confidence among students in the CBL-3DP group, highlighting the positive impact of incorporating 3D printed models into the learning environment, improving the effectiveness of CBL classroom instruction. Despite the merits, our study has limitations. Primarily, participants were exclusively drawn from the same grade level within a single college, possibly engendering bias owing to shared learning backgrounds. Future research could further strengthen these findings by expanding the sample size and including long-term follow-up to assess the retention of knowledge and skills. Additionally, the influence of the 3D models depicting a normal heart on the learning process and its potential to introduce bias into the results warrants consideration, highlighting a need for scrutiny in subsequent studies.

As medical science continues to advance, the need for effective teaching methods becomes increasingly paramount. Our study underscores the potential of combining active learning approaches like CBL with innovative technologies such as 3D printing to enhance teaching effectiveness, improve knowledge acquisition, and foster students’ confidence and enthusiasm in pursuing clinical careers. Moving forward, further research and integration of such methodologies are essential for meeting the evolving demands of medical education, especially in areas involving complex anatomical understanding.


Integrating 3D-printed models with the CBL method is feasible and effective in TOF instruction. The demonstrated success of this method warrants broad implementation in medical education, particularly for complex anatomical topics.

Data availability

All data supporting the conclusions of this research are available upon reasonable request from the corresponding author.

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We extend our sincere appreciation to the instructors and students whose invaluable participated in this study.

This paper received support from the Education Department of Anhui Province, China (Grant Numbers 2022jyxm1693, 2022jyxm1694, 2022xskc103, 2018jyxm1280).

Author information

Jian Zhao and Xin Gong are joint first authors.

Authors and Affiliations

Department of Human Anatomy, Wannan Medical College, No.22 West Wenchang Road, Wuhu, 241002, China

Jian Zhao, Xin Gong, Jian Ding, Rui Huang & Huachun Miao

Department of Cardio-Thoracic Surgery, Yijishan Hospital of Wannan Medical College, Wuhu, China

Kepin Xiong

Zhuhai Sailner 3D Technology Co., Ltd., Zhuhai, China

Kangle Zhuang

School of Basic Medical Sciences, Wannan Medical College, Wuhu, China

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Jian Zhao and Huachun Miao designed the research. Jian Zhao, Xin Gong, Jian Ding, Kepin Xiong designed the tests and questionnaires. Kangle Zhuang processed the imaging data and printed the models. Xing Gong and Kepin Xiong implemented the teaching. Jian Zhao and Rui Huang collected the data and performed the statistical analysis. Jian Zhao and Huachun Miao prepared the manuscript. Shu Li and Huachun Miao revised the manuscript. Shu Li provided the Funding acquisition. All authors reviewed and approved the final manuscript.

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Correspondence to Shu Li or Huachun Miao .

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This investigation received ethical approval from the Ethical Committee of School of Basic Medical Sciences, Wannan Medical College (ECBMSWMC2022-1-12). All methodologies adhered strictly to established protocols and guidelines. Written informed consent was obtained from the study participants to take part in the study.

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Zhao, J., Gong, X., Ding, J. et al. Integration of case-based learning and three-dimensional printing for tetralogy of fallot instruction in clinical medical undergraduates: a randomized controlled trial. BMC Med Educ 24 , 571 (2024).

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Racial and Ethnic Disparities in Access to Medical Advancements and Technologies

Nambi Ndugga , Drishti Pillai , and Samantha Artiga Published: Feb 22, 2024


Racial and ethnic disparities in health outcomes remain persistent in the United States, driven by inequities in access to and utilization of health care services and broader social and economic factors that reflect historic and ongoing racism. Given higher rates of certain illnesses among people of color, they could disproportionately benefit from medical advancements such as new drugs and therapies. However, they face increased barriers to accessing new drug therapies and treatments due to lack of diversity in clinical trials and structural barriers, including financial barriers. These disparities in access to medical advancements may further exacerbate racial disparities in health outcomes and life expectancy. This brief provides an overview of diversity in clinical trials, disparities in access to novel drug therapies and other treatments, and the implications for health and health care.

Diversity in Clinical Trials

Diverse racial and ethnic representation in clinical trials is important because drugs, vaccines, and other therapies can differentially affect groups due to variations in underlying experiences and environmental exposures. Clinical trials  are research studies that determine whether medical products like medicines, vaccines, or devices are safe and effective. It is important that participants in clinical trials represent the future users of these medical products as responses to them may vary across patient groups by factors such as gender, race, ethnicity, and age because of variations in underlying experiences and environmental exposures. Having the demographics of clinical trial participants mirror the population intended to use the product can help to ensure its effectiveness and safety across patients, which may help improve health outcomes of the overall population. Racial and ethnic diversity in clinical trials also is important for building confidence in the effectiveness of new treatments. For example, research shows that Black people are more likely to have confidence in a new treatment when the trial had a greater representation of Black people.

Access barriers, lack of information, and historic and ongoing structural racism and discrimination contribute to the underrepresentation of people of color in clinical trials.  People of color face an array of structural access-related barriers to participating in clinical trials. For example,  fewer clinical trials  are available through under-resourced hospital systems where people of color are more likely to receive care, and people of color may be less likely to be eligible to participate in trials if being uninsured or having comorbidities excludes individuals from participation. Other access challenges like limited transportation options, inflexible work schedules, and lack of access to technology may also impede participation. Beyond access barriers, knowledge gaps contribute to underrepresentation. Research indicates that physicians are less likely to discuss trials with patients of color. In addition, some patients are denied coverage for services rendered under clinical trials by their health coverage plans. Research shows that increases in education and understanding of clinical trials are associated with increased interest in participating in clinical trials. Further, ensuring enrollment efforts are culturally sensitive and addressing language and health literacy differences is important. Historical medical abuses of people of color as well as ongoing racism and discrimination may also foster reluctance among people of color to engage in clinical trials. However, research suggests that many people of color are willing to participate in clinical trials when provided the opportunity to do so.

There have been growing efforts  to increase diversity in clinical trials. The National Institutes of Health (NIH) has longstanding  guidelines  on the inclusion of women and other underrepresented groups in clinical research and identified representative participation of underrepresented groups in NIH-funded research as a goal of its Minority Health and Health Disparities (NIHMD) 2021-2025 strategic plan . The NIMHD sponsors funding opportunities to increase the enrollment of people of color into clinical trials. The  Food and Drug A dministration (FDA) has a public education campaign, collaborates with stakeholders, provides clinical trial information in a variety of languages, and has identified actionable steps to improve diversity in clinical trials. It also has provided guidelines  on the collection of race and ethnicity data in clinical trials and, in 2022, issued draft guidance to the industry for developing plans to increase diversity in clinical trials. During the development of the COVID-19 vaccines, the FDA offered nonbinding industry recommendations that strongly encouraged “enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities.” Pfizer  and Moderna made efforts to include people of color in their COVID-19 vaccine trials, and historically Black colleges and universities encouraged participation in their communities. At the industry level, the Pharmaceutical Research and Manufacturers of America implemented an Equity Initiative in 2022. It has engaged in with academic centers, community organizations, and other health partners to launch Equitable Breakthroughs in Medicine Development , a collaboration that seeks to pilot a network of sustainable, connected, and community-based trial sites.

Research suggests that collaborating with community clinicians may help increase diversity in clinical trials. It is suggested that engaging community clinics in clinical research could enhance diversity since they have established, trusted relationships with patients and can reduce accessibility and enrollment barriers for patients. A recent survey of leadership at community health centers, which serve disproportionate shares of low-income people and people of color, found that most responding health centers are interested in conducting research but face time and workforce constraints to participating in research. However, some collaborate with other organizations, such as academic institutions, to conduct this research, allowing for varied stakeholder strengths and perspectives to inform it.

Despite efforts to increase diversity, people of color remain underrepresented in clinical trials and other medical development research . Analysis finds that more than half of U.S. trials listed on between 2000 and 2020 did not report enrollment data by race and ethnicity, although the share reporting any racial and ethnic enrollment data increased over time. The analysis further shows that, although there were modest improvements in diversity of trial participants over time, among trials that reported racial and ethnic data, people of color continued to be underrepresented relative to their share of the population. Between 2000 to 2020, the median enrollment of Hispanic (6%), Asian (1%), and American Indian and Alaska Native (AIAN) (0%) people was lower compared to their makeup of the total U.S. population based on the 2010 Census (Figure 1). The median enrollment of Black people was not statistically significantly lower than their share of the population as of 2010, but 21% of trials reported zero Black enrollees. Conversely, White people were overrepresented in clinical trials, with a median enrollment of 80%, and 10% of trials reported 100% White enrollees. Given that the U.S. population became more racially and ethnically diverse between 2010 to 2020 , this overrepresentation has persisted. The analysis further found that industry-funded trials were associated with less racial and ethnic reporting and lower rates of enrollment of people of color compared with U.S. government-funded trials even after controlling for differences in features of the trials.

Other analysis of FDA drug approvals from 2014 to 2021 found that the median representation of Black participants was one-third of the disease burden in the population and no increases in their representation relative to White participants over the period. Even in clinical trials for COVID-19 vaccinations, which demonstrated relatively better diversity, publicly accessible data still indicated an overall underrepresentation of people of color compared to their proportion of the total U.S. population, with Black individuals having the largest disparity in representation.

Disparities in Access to New Drugs and Therapies

Lack of diversity in clinical trials may exacerbate existing disparities in treatment access for people of color. The lack of diversity in clinical trials may limit access to new drugs and therapies as their approval and indications may be limited to the populations included in the studies and clinical guidelines and insurance reimbursement may be limited by the lack of data for certain populations. For example, in 2021, the U.S. Preventive Services Task Force indicated it was unable to make specific colorectal cancer screening guidelines for Black people despite them having the highest incidence and mortality rates from colorectal cancer, due to the lack of representative cancer screening studies.

New drugs and therapeutics often have high out-of-pocket costs which may lead to disproportionate access barriers among people of color. Newly developed drugs and treatments often come with high costs that reflect development costs. In some cases, these treatments are not covered by insurance , and even when they are, they may still have high out-of-pocket costs. Patient discounts for drugs may be available but access to them may be varied and could become more limited. Due to underlying social and economic inequities, people of color are more likely than their White counterparts to be uninsured and have lower incomes meaning they likely face disproportionate cost barriers to these drugs and treatments. At the same time, people of color have worse health outcomes and higher rates of certain conditions, suggesting they potentially could disproportionately benefit from new drugs and treatments. For example:

  • The recently FDA-approved Alzheimer’s drug Leqembi has a current list price of $26,500. Even though it is covered by Medicare, Medicare patients administered the drug face more than $5,000 in out-of-pocket costs per year, based on a 20% coinsurance requirement in traditional Medicare, although those with supplemental insurance may have lower costs. With higher rates of dementia and lower incomes among older Hispanic and Black adults than their White counterparts, the high cost of treatment could raise equity concerns if Black, Hispanic, and other underserved beneficiaries are less likely to gain access to this treatment because they can’t afford it.
  • Similarly, the emergence of new medications for obesity treatment has raised questions about who can access them and the potential impacts on racial health disparities. Access to these medications varies and they remain unaffordable for many individuals given that they currently are excluded from Medicare coverage, coverage through Medicaid and private plans  remains limited, and out-of-pocket costs  without coverage can be in excess of $1,300  per month. Although most people with obesity are White, many people of color are at increased risk for obesity, meaning they could benefit from new treatment options. However, they also are more likely than their White counterparts to face barriers to affording and accessing the new medications.
  • Concerns have also been raised surrounding access to new gene therapies for sickle cell disease, an illness that disproportionately impacts Black and Hispanic people. While gene therapies provide the opportunity for a highly effective one-time treatment, they come with a hefty price point—gene therapy prices for a one-time use can cost more than $2 million .

Biases in clinical decision-making processes and technologies and limitations in access to providers may also create disproportionate access barriers for people of color. Clinical algorithms and other decision-making tools are used by physicians to guide clinical diagnoses and inform treatment plans. People of color may be less likely to receive prescriptions for effective therapies due to decision making processes that incorporate race in clinical algorithms and treatment guidelines. Research  has shown that these algorithms and tools may have racial bias because the underlying data on which they are trained may be biased and/or may not reflect a diverse population. For example, recent research shows that pulse oximeters have lower accuracy for patients with darker skin. Heightened attention to this issue during the COVID-19 pandemic prompted the FDA to consider how to improve studies used to assess their performance. Differences in access to providers, including specialists who may have greater knowledge about new therapies, may also create access barriers as well as concerns about utilizing newly developed drugs or therapies given the legacy of medical system abuses. For example, analysis from 2022 shows that Black and Hispanic patients were 36% and 30%, respectively, less likely to receive nirmatrelvir-ritonavir (Paxlovid) treatment than White patients for COVID-19. Researchers suggested these disparities likely reflected more limited access to COVID-19 treatment facilities; potential prior negative experiences with the health care system, racism, or implicit bias among providers; as well as social and economic factors such as limited knowledge of treatment options, limited technology access, limited transportation, and/or language barriers.

Implications and Key Issues Looking Ahead

While some efforts are being made to mitigate disparities in access to new drugs and therapies, continued actions will be important going forward for preventing widening disparities.

As noted above, there are ongoing efforts to increase diversity in clinical trials. Under the Food and Drug Omnibus Reform Act , which was enacted as part of the Consolidated Appropriations Act of 2023 , the FDA will require diversity action plans for certain clinical trials that specify enrollment goals to address historical underrepresentation of certain groups. The FDA has existing draft guidance that provides recommendations on diversity action plans. Under the legislation, the FDA can update or issue new guidance to implement the action plan requirements.

Expanding coverage for new drugs, treatments, and therapies could mitigate some financial access barriers, but disparities in financial barriers may still persist. A bipartisan group of lawmakers introduced  the Treat and Reduce Obesity Act , which would authorize Medicare Part D coverage of medications when used for the treatment of obesity or weight loss management in overweight individuals with related comorbidities. As of July 2023, sixteen states  reported Medicaid Fee-For-Service coverage of at least one weight-loss medication for the treatment of obesity for adults. The newly developed Alzheimer’s drug, Leqembi, already is covered by Medicare for all indicated populations . Having coverage available for these new drugs may help address some disparities in financial access barriers. However, even with coverage, uninsured individuals would continue to face financial barriers and some covered individuals may continue to face substantial out-of-pocket costs, leaving treatments unaffordable.

Prioritizing equity in access to new treatments is of increasing importance amid the growing use of clinical algorithms and artificial intelligence (AI) to guide health care. As use of AI grows in health care, it will be important to ensure that algorithms do not perpetuate disparities and biases through the use of race or due to biases in the underlying data upon which they rely. Research further suggests that if carefully designed , algorithms could  mitigate bias  and help to reduce disparities in care. There have been recent federal and state level efforts to reduce and protect against bias in the use of AI and clinical algorithms. The FDA proposed a framework to monitor and evaluate the use, safety, and effectiveness of AI, which includes a focus on improving methods to identify, evaluate, and address algorithmic bias. In 2022, the Department of Health and Human Services (HHS) issued a proposed rule that prohibits discrimination through the use of decision-making clinical algorithms, although researchers have noted that the proposed rule does not offer specific guidelines on how to prevent discrimination and that there are a wide range of potential strategies available for reducing bias in clinical algorithms. In December 2023, HHS finalized a rule that implements new transparency requirements for clinical decision support tools and algorithms to ensure users have access to a baseline set of information that supports their ability to assess their “fairness, appropriateness, validity, effectiveness, and safety.” At the state level, at least eleven states have begun regulating the use of AI and algorithms in health care in an effort to mitigate instances of discrimination. In early 2023, the Coalition for Health AI released guidance for the implementation of AI to increase trustworthiness and transparency in AI tools that centers equity, fairness, and ethics. The guidance includes recommendations on developing a common set of principles to guide the development and use of AI tools and a coalition or advisory board to help ensure equity and facilitate trustworthiness in health-related AI.

  • Racial Equity and Health Policy
  • Race/Ethnicity
  • Access to Care
  • American Indian/Alaska Native

Also of Interest

  • How Present-Day Health Disparities for Black People Are Linked to Past Policies and Events
  • What is Driving Widening Racial Disparities in Life Expectancy?
  • Medicaid and Racial Health Equity


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    Clinical Departments. Our clinical departments focus lies at the core of what our school does. They provide an exemplary educational foundation for our M.D. students, residents and fellows, while partaking in cutting edge research and providing patient-centered care.

  25. Understanding enterprise data warehouses to support clinical and

    Healthcare organizations, including Clinical and Translational Science Awards (CTSA) hubs funded by the National Institutes of Health, seek to enable secondary use of electronic health record (EHR) data through an enterprise data warehouse for research (EDW4R), but optimal approaches are unknown.

  26. Integration of case-based learning and three-dimensional printing for

    Background Case-based learning (CBL) methods have gained prominence in medical education, proving especially effective for preclinical training in undergraduate medical education. Tetralogy of Fallot (TOF) is a congenital heart disease characterized by four malformations, presenting a challenge in medical education due to the complexity of its anatomical pathology. Three-dimensional printing ...

  27. Penn Medicine at the 2024 ASCO Annual Meeting

    CHICAGO - Researchers from Penn Medicine's Abramson Cancer Center (ACC) and the Perelman School of Medicine at the University of Pennsylvania will present data on the latest advances in cancer research at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, happening May 31—June 4, 2024 in Chicago and online.Follow @PennMedicine and @PennMDForum for updates.

  28. Racial and Ethnic Disparities in Access to Medical Advancements ...

    Research shows that increases in education and understanding of clinical trials are associated with increased interest in participating in clinical trials. Further, ensuring enrollment efforts are ...