Toward a Framework to Improve Diversity and Inclusion in Clinical Trials

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Despite decades of ongoing efforts to improve racial and ethnic diversity in clinical trials, many gaps remain in achieving demographic representation in clinical studies. In May 2024, the National Academies Forum on Drug Discovery, Development, and Translation, in collaboration with the National Cancer Policy Forum, hosted a public workshop to explore system-level changes and initiatives across organizations and sectors to improve representation, data collection, and reporting in clinical trials and progress tracking in the United States.

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124 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-73145-3
ISBN Ebook: 0-309-73146-1
DOI: https://doi.org/10.17226/28587

Suggested citation

National Academies of Sciences, Engineering, and Medicine. 2025. Toward a Framework to Improve Diversity and Inclusion in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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Freda Lewis-Hall

FREDA LEWIS-HALL, M.D., (CHAIR) is the former executive vice president & chief medical officer at Pfizer. Trained as a psychiatrist, she has held leadership roles in academia, medical research, front-line patient care, and at global biopharmaceutical companies including Vertex, Bristol-Myers Squibb, and Eli Lilly. Prior to her work in industry, she led research projects for the National Institutes of Health and was vice chairperson of the Department of Psychiatry at Howard University College of Medicine. In 2010, Dr. Lewis-Hall was appointed by the Obama Administration to the inaugural Board of Governors for the Patient-Centered Outcomes Research Institute (PCORI) and, in 2012, she was appointed chair of the Cures Acceleration Network Review Board and a member of the National Center for Advancing Translational Sciences (NCATS) Advisory Council of the National Institutes of Health. She also serves on the executive committee of the Clinical Trials Transformation Initiative and on numerous other boards, including those of Harvard Medical School, The Institute of Medicine's Forum on Drug Discovery, Development, and Translation, and Save the Children. Dr. Lewis-Hall received a Bachelor of Arts and Sciences from Johns Hopkins University and her Medical Doctorate from Howard University Hospital and College of Medicine. Dr. Lewis-Hall was named one of Savoy's Top Influential Women in Corporate America in 2012, and was selected as the Healthcare Businesswomen's Association’s 2011 "Woman of the Year."

Barbara E. Bierer

BARBARA E. BIERER, M.D., is a hematologist-oncologist, is Professor of Medicine at Harvard Medical School (HMS) and the Brigham and Women’s Hospital (BWH). Dr. Bierer is the Faculty Director of the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center), a collaborative effort to improve standards for the planning and conduct of international clinical trials. She is also the Director of the Regulatory Foundations, Ethics, and Law program at the Harvard Catalyst, and PI and Director of SMART IRB. She serves as Faculty in the Center for Bioethics, HMS, and Affiliate Faculty in the Petrie-Flom Center for Health Law at Harvard Law School. She is a co-founder of COVID-19 Collaboration Platform and of the non-profit Vivli, a global clinical research data sharing platform. From 2003 – 2014, Dr. Bierer served as Senior Vice-President, Research, BWH where she founded the Brigham Research Institute and the Brigham Innovation Hub. She is a past chair of SACHRP and has served or serves on the Board of Directors of AAHRPP, PRIMR, MSH, Vivli, North Star IRB, and the Edward P. Evans Foundation. She has authored over 275 publications. Dr. Bierer received her BS from Yale University and her MD from Harvard Medical School.

Silas Buchanan

SILAS BUCHANAN is the Founder and CEO of the Institute for eHealth Equity, a social impact consulting firm. Silas is an experienced underserved community engagement strategist, dedicated to building equitable partnerships and crafting web-based ecosystems that solve for known, outreach and engagement failure points. Silas partnered with the AME Church (2000 congregations and 2 million members) to build and launch www.amechealth.org as their official health information sharing, and data collecting website. He then led the development of strategic partnerships with healthcare, wellness, and Pharma organizations. He is currently working with the start-up, OurHealthyCommunity.com, to redevelop the platform to better engage underserved communities both secularly and non-secularly. Silas has contributed thought leadership to the National Academies of Medicine, Milken Institute's FasterCures, the Clinical Trials Transformation Initiative, Morehouse School of Medicine, Duke Clinical Research Institute, HIMSS, Accenture, American Telemedicine Association, Digital Medicine Society, and the Kraft Precision Medicine Accelerator at Harvard Business School, among many others.

Luther T. Clark

LUTHER T. CLARK, M.D., is Deputy Chief Patient Officer and Global Director, Scientific Medical and Patient Perspective in the Office of the Chief Patient Officer at Merck. In this role, he is responsible for (1) gathering internal and external scientific and medical information to assist with decision-making at the highest levels; (2) collaborating across Merck to increase the voice of patients, directly and indirectly in decision-making; (3) collaborating with key internal and external stakeholders in development of a systematized approach for collecting and incorporating patient insights across the patient journey and product lifecycle; and (4) representing Merck externally, expanding bi-directional exchange with key patient and professional leaders and organizations. Dr. Clark leads Merck’s Patient Insights Team, is co-leader of the team that champions Health Care Equities (including promotion of health literacy and research diversity) and chairs the Patient Engagement, Health Literacy & Clinical Trials Diversity Investigator Initiated Studies Research Committee. Prior to joining Merck, Dr. Clark was Chief of the Division of Cardiovascular Medicine at the State University of New York Downstate Medical Center (SUNY Downstate) and founding Director of the NIH-funded Brooklyn Health Disparities Research Center. Dr. Clark earned his Bachelor of Arts degree from Harvard College and his Medical degree from Harvard Medical School. He is a Fellow of the American College of Cardiology and the American College of Physicians, and a past member of the Board of Directors of the Founders Affiliate of the American Heart Association. He is a nationally and internationally recognized leader in cardiovascular education, clinical investigation, cardiovascular disease prevention, and health equity. He has authored more than 100 publications and edited and was principal contributor to the textbook Cardiovascular Disease and Diabetes (McGraw-Hill). Dr. Clark has received numerous awards and honors, including the Harvard University Alumni Lifetime Achievement Award for Excellence in Medicine. He is the current President of the Health Science Center at Brooklyn Foundation, SUNY Downstate Medical Center.

Marianne Hamilton Lopez

MARIANNE HAMILTON LOPEZ, PH.D., M.P.A., is a Senior Research Director, Adjunct Associate Professor and Core Faculty at the Duke-Margolis Center for Health Policy at Duke University. Previously, Dr. Hamilton Lopez was a senior program officer at the National Academy of Medicine where she oversaw the Leadership Consortium for a Value & Science-Driven Health System’s Science and Technology portfolio and directed the Clinical Effectiveness Research Collaborative and the Digital Health Collaborative. She held senior positions at Academy Health, the United States Cochrane Center, and the National Institutes of Health. Dr. Hamilton Lopez’s work focuses on facilitating a more efficient, affordable, and equitable biomedical pathway. She leads the Duke-Margolis Biomedical Innovation program, which focuses on medical product development and regulation, clinical trials, real world evidence, digital health, payment and coverage, and drug pricing and competition. She recently oversaw the development of the Advancing Clinical Trials at the Point-of-Care coalition which aims to drive the implementation of representative clinical trial networks to support rapid evidence development. Dr. Hamilton Lopez earned a PhD from UMBC, an MPA from The George Washington University, and a BA from Earlham College. She is also a graduate of the Department of Health and Human Services’ Emerging Leaders Program.

Morgan Hanger

MORGAN HANGER, M.P.P., is the Executive Director of the Clinical Trials Transformational Initiative (CTTI), a public-private partnership between Duke University and the U.S. Food and Drug Administration. She has deep experience convening organizations to solve complex problems related to evidence generation and is passionate about data ethics and transparency. Prior to CTTI, Hanger worked at health technology companies focused on patients. Notably, Hanger served as vice president of the online patient research network PatientsLikeMe (PLM), where she led partnerships to utilize patient-generated health data in life sciences and regulatory settings. Prior to PLM, Hanger worked in advisory services for Avalere Health, where she helped pharma, biotech, and professional societies create more effective research strategies. She has also held positions within the Health Outcomes Group at Memorial Sloan Kettering Cancer Center and at the Congressional Budget Office. Ms. Hanger graduated summa cum laude from New York University with a BA in politics and holds a master’s degree in public policy from the University of California, Berkeley.

Esther Krofah

ESTHER KROFAH, M.P.P., is the executive vice president of MI Health, leading FasterCures, Public Health, the Future of Aging and Feeding Change. She has extensive experience managing efforts to unite diverse stakeholders to solve critical issues and achieve shared goals that improve patients’ lives. Most recently, Krofah was the director of public policy at GlaxoSmithKline (GSK), where she led engagement with the US Department of Health and Human Services (HHS) and relevant Executive Branch agencies on broad healthcare policy issues. Before GSK, Krofah was a deputy director of HHS’ Office of Health Reform. She also served as program director at the National Governors Association healthcare division and worked in consulting at Deloitte Consulting LLP. Krofah received a B.A. from Duke University and a Master of Public Policy from the Harvard University John F. Kennedy School of Government.

Martin Mendoza

MARTIN MENDOZA, PH.D., serves as the director of health equity for the All of Us Research Program. In this role, he provides leadership and high-level expertise to improve inclusion and equity in precision medicine and leads the program’s efforts to promote health equity. Before joining All of Us, Martin led extramural research for minority health in the Office of the Commissioner at the U.S. Food and Drug Administration (FDA). He is a recognized expert in clinical trial diversity and has testified on it before Congress. He is also the primary author of the pivotal FDA guidance recommending that clinical trial sponsors be required to submit a diversity and inclusion plan to FDA. Martin’s original idea and recommendation became federal law in December 2022. Martin has also served as director of the Division of Policy and Data in the Office of Minority Health in the Office of the Secretary at the U.S. Department of Health and Human Services, as well as in the Division of Clinical Research at the National Institute of Neurological Disorders and Stroke. He conducted his primary research training in the National Cancer Institute’s Pediatric Oncology Branch and helped to map chromosome 7 as part of the Human Genome Project during his tenure at the National Human Genome Research Institute. Martin is a graduate of the University of Maryland, Baltimore County, and received his Ph.D. in cancer biology from Johns Hopkins University.

Carla Rodriguez-Watson

CARLA RODRIGUEZ-WATSON, PH.D., M.P.H., is the Director of Research for the Reagan-Udall Foundation for the FDA. Prior to this post, she was an investigator at Kaiser Permanente Mid-Atlantic Research and at the University of Washington. But her heart lies where it all began, in service of public health. Carla devoted over a decade to the service of public health in the New York City, San Francisco, and Seattle-King County Health departments in communicable disease and environmental epidemiology & surveillance. Her exposure and love for the complexity of real-world-data and its potential was born in public health. Today, Carla is focused on continuously developing and enhancing a portfolio of work to advance and leverage real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies. This work includes: improving the quality and relevance of RWD (including data needed to advance health equity), developing and advancing frameworks and tools to systematically describe data sources and methods for use in pre and post-market studies of product safety and effectiveness; as well as the Innovation in Medical Evidence, Development and Surveillance (IMEDS) Program – where such tools can be leveraged and tested for regulatory and non-regulatory studies. Carla brings her extensive background in public health surveillance, health outcomes research, and pharmacoepidemiology to this work.

Michelle Tarver

MICHELLE TARVER, M.D., PH.D., is a board-certified ophthalmologist and epidemiologist, serving as the Deputy Center Director for Transformation. In this role, Dr. Tarver facilitates the development, implementation, and direction of CDRH’s transformative projects and initiatives. Under her leadership, CDRH is advancing efforts to include underserved and underrepresented populations in the evaluation of medical devices, including people across diverse age, sex, gender, racial, and ethnic backgrounds; those living with rare diseases and physical limitations; and those living in rural areas. Her CDRH career has included many leadership roles, most recently as the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement. Over her career, she has received numerous awards, including the American Academy of Ophthalmology’s Secretariat Award and is widely published in peer-reviewed journals. Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health. Following her internal medicine internship, she completed a residency in ophthalmology with fellowship training in ocular inflammation (uveitis) both at the Wilmer Eye Institute (Johns Hopkins). Board-certified in ophthalmology with an epidemiology doctorate, she has worked on laboratory-based and epidemiological studies, clinical trials, registries, developing patient-reported outcome measures as well as surveys to capture patient preferences. As a dedicated clinician, she continues to care for people living with eye disease.

Robert A. Winn

ROBERT A. WINN., M.D., is the director of VCU Massey Comprehensive Cancer Center who oversees a cancer center designated by the National Cancer Institute that provides advanced cancer care, conducts groundbreaking research to discover new therapies for cancer, offers high-quality education and training, and engages with the community to make advancements in cancer treatment and prevention equally available to all. He is leading the nation in establishing a 21st-century model of equity for cancer science and care, in which the community is informing and partnering with Massey on its research to best address the cancer burden and disparities of those the cancer center serves, with a local focus but global impact. His current basic science research, which has been supported by multiple National Institutes of Health and Veterans Affairs Merit awards, focuses on the molecular mechanisms and novel therapeutic approaches for human models of lung cancer. He has authored or co-authored more than 80 published manuscripts in peer reviewed academic journals. As a pulmonologist, Winn is committed to community-engaged research centered on eliminating health disparities. He is a principal investigator on several community-based projects funded by the NIH and National Cancer Institute, including the All of Us Research Program, a NIH precision medicine initiative. Winn has nearly 20 years’ commitment to Veterans Affairs health services and held appointments at the Denver VA and Jesse Brown VA in Chicago, where he established the first multidisciplinary pulmonary nodule clinic. Winn is the President of the Association of American Cancer Institutes (AACI); the Chair of the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine; a Fellow of the American Association for Cancer Research (AACR) Academy; and a member of the Board of Directors for the American Cancer Society and LUNGevity Foundation. The recipient of numerous awards and honors, Winn has received the National Cancer Institute Center to Reduce Cancer Health Disparities CURE Program Lifetime Achievement Award; the AACR-Minorities in Cancer Research Jane Cooke Wright Lectureship; the AACI Cancer Health Equity Award; and the Prevent Cancer Foundation Cancer Prevention and Early Detection Laurel Award for Increasing Health Equity. In 2022, the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program was renamed the Robert A. Winn Diversity in Clinical Trials Award Program (Winn Award), which is committed to increasing diversity in clinical trials and training the new generation of community-oriented clinical researchers. Winn holds a B.A. from the University of Notre Dame and an M.D. from the University of Michigan Medical School in Ann Arbor. He completed an internship and residency in internal medicine at Rush-Presbyterian-St. Luke’s Medical Center in Chicago and a fellowship in pulmonary and critical care medicine at the University of Colorado Health Sciences Center in Denver.

Workshop

Toward a Framework to Improve Diversity and Inclusion in Clinical Trials - A Workshop

May 20, 2024

8:30 AM - 2:00 PM (EDT)

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About

A planning committee of the National Academies of Sciences, Engineering, and Medicine organized a public workshop to explore opportunities to improve representation in clinical trials with a focus on system-level change and collective efforts across organizations and sectors that no one entity can effectively take on alone. This workshop built upon previous meetings hosted by the Clinical Trials Transformation Initiative in June 2023, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard in September 2023, and Milken Institute's FasterCures in November 2023.
The public workshop featured invited presentations and discussions to:

Explore strategies for equitable participation, including innovative trial designs and partnerships to support community investment, engagement, and workforce development.
Highlight ways that stakeholders can contribute to sustainable and scalable public awareness campaigns.
Discuss business plans and funding mechanisms to allocate financial resources to improve clinical trial diversity.
Consider ways to enable established and developing sites to increase capacity to conduct more equitable and representative clinical trials.
Examine components of national, interoperable, and accountable systems for collecting and sharing condition-specific demographic data.

Planning Committee

Freda Lewis-Hall (Chair), Retired

Barbara E. Bierer, MRCT Center

Silas Buchanan, Institute for eHealth Equity

Luther Clark, Merck & Co. Inc

Marianne Hamilton Lopez, Duke-Margolis Center for Health Policy

Morgan Hanger, Clinical Trials Transformation Initiative

Esther Krofah, FasterCures, Milken Health Institute

Martin Mendoza, Centers for Medicare & Medicaid Services

Carla Rodriguez-Watson, Reagan-Udall Foundation for the FDA

Michelle Tarver, FDA Center for Devices and Radiological Health

Robert A. Winn, VCU Massey Comprehensive Care Center

Contact

Kyle Cavagnini

KCavagnini@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Toward a Framework to Improve Diversity and Inclusion in Clinical Trials - A Workshop

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