This work began in May 2017, at an MRCT Center Bioethics Collaborative, a neutral forum during which a number of clinical research stakeholders convened to discuss diversity in clinical trials. The attendees of that meeting, represented by a multi-stakeholder group of industry, academia, government, and patient advocacy, agreed that the participant population enrolled in a clinical trial ought to be representative of the general population at a minimum and, optimally, of the intended population for the intervention. If study populations are skewed, if they lack diversity, then the safety and efficacy, effectiveness, and value of medical interventions—the biological heterogeneity of treatment effect—cannot be adequately investigated and understood. Justice issues also influence the diversity – or lack thereof – of study populations, with a fundamental unfairness perceived if specific populations are either disproportionately burdened or unfairly excluded from study enrollment. The attendees at that meeting agreed that, despite the understood necessity as a matter of science and ethics, underrepresentation of gender, sex, ethnic, and racial minorities in drug development, and in clinical research more generally, persists.
These stark and sobering observations led to a robust discussion at the Bioethics Collaborative: diverse representation is a principle of justice and of a just society, and our collective failure to achieve diversity is a solvable albeit difficult problem. Since that time, there have been numerous additional reports in both the scientific literature and the public press recounting the lack of diversity in clinical trials, across the spectrum of demographic dimensions of diversity: age, race, ethnicity, sex, gender identity, sexual orientation, disability, urban/rural residence, as well as non-demographic variables such as comorbidities, polypharmacy, organ dysfunction, etc.
Understanding the problem and finding approaches to mitigate underrepresentation requires focus and commitment, data, etc. Eliminating racism, ableism, homophobia, and other inequalities begins with eliminating disparities in health, and that necessarily demands deliberate and purposeful inclusion in health research that itself will help lead to equitable access and outcomes. While we would like to believe that the work presented in the associated assets listed below is timely and relevant, in fact, it is long overdue, and it is only a beginning. We appreciate that and are grateful to everyone who has worked on this issue over many decades, and with us on evolving projects since 2017. We also recognize that this work requires extensive collaboration to align goals for system-wide change, and for this reason, the MRCT Center partnered with several organizations leading on advancing diversity in clinical trials to form the Diversity Convergence Project. Together we have hosted a series of convenings, beginning in 2023, and are working to drive collective action. Every member of the clinical research enterprise must commit, engage, and respond for real change to be lasting and impactful.
Please note: The materials listed on this page focus on race and ethnicity, but the underlying principles and actions are meant to support the representation of all underrepresented populations. For materials that address other specific underrepresented populations (e.g., people who are LGBTQIA, people with disabilities), please see the MRCT Center webpages for those populations.
Associated Assets:
- Diversity Convergence Project: Toward a National Action Plan for Achieving Diversity in Clinical Trials
- Data Visualization Explorer: A tool for participant representation
- Equity by Design (EbD) in Clinical Research Metrics Framework
- Equity by Design in Clinical Research: A Six-Part Course
- MRCT Center Comment Diversity Plans to Improve Enrollment of Participants from Underrepresented Populations
- MRCT Center Leaning-In Webinar Series
- Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document
- Achieving Diversity, Inclusion, and Equity in Clinical Research Toolkit and User Guide
Please note: The tools listed above are living documents and will be improved with use. We welcome feedback, suggestions, useful references, resources, and concerns.
Acknowledgments
Many thanks to everyone who has so thoughtfully collaborated on these projects. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed in project materials are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work.
Diversity Convergence Project
Diversity Convergence Project – Leadership
- Dr. Barbara Bierer, Faculty Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Esther Krofah, Executive Vice President of MI Health, Milken Institute
- Morgan Hanger, Executive Director, Clinical Trials Transformation Initiative (CTTI)
- Freda Lewis-Hall, Former Executive Vice President and Chief Medical Officer, Pfizer
- Carolyn Shore, Director, Forum on Drug Discovery, Development, and Translation,National Academics of Science, Engineering, and Medicine (NASEM)
Diversity Convergence Project – Working Group
- Hayat Ahmed, Program Manager, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Sarah Bristol Calvert, Director of Projects, Clinical Trials Transformation Initiative (CTTI)
- Kyle Cavagnini, Associate Program Officer, National Academics of Science, Engineering, and Medicine (NASEM)
- Dr. Willyanne DeCormier Plosky, Program Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Alex Helman, National Academics of Science, Engineering, and Medicine (NASEM)
- Yasmeen Long, Director at MI Health, FasterCures at the Milken Institute
- Sruthi Meka, Senior Associate, Faster Cures at the Milken Institute
- Sabrena Mervin-Blake, Senior Project Manager,Clinical Trials Transformation Initiative (CTTI)
- Sally Okun, Former Executive Director,Clinical Trials Transformation Initiative (CTTI)
EQUITY BY DESIGN IN CLINICAL RESEARCH METRICS FRAMEWORK
Equity by Design in Clinical Research Metrics Framework – Leadership
- Dr. Barbara Bierer, Faculty Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Hayat Ahmed, Project Manager, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Dr. Willyanne DeCormier Plosky, Program Manager, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Laura Meloney, Program Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Sarah White, Executive Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
Equity by Design in Clinical Research Metrics Framework – Working Group
- Dr. Philip M. Alberti, Association of American Medical Colleges (AAMC)
- Maria Apostolaros, Pharmaceutical Research and Manufacturers of America (PhRMA)
- RADM Richardae Araojo, U.S. Food and Drug Administration (FDA)
- Jennifer Dexter, National Health Council (NHC)
- Dr. Milena Lolic, U.S. Food and Drug Administration (FDA)
- Yasmeen Long, Faster Cures/Milken Institute
- Dr. Vanessa Marshall (National Institutes of Health (NIH)
- Sophia McLeod, Association of Clinical Research Organizations (ACRO)
- Dr. James Powell, knowRx; Association of Multicultural Physicians
- Silke Schoch, National Health Council (NHC)
- Dr. Camelia Thompson, Biotechnology Innovation Organization (BIO)
Equity by Design in Clinical Research Metrics Framework – Reviewers
- Colleagues at the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
- Colleagues at Merck
- Dr. Rodrigo Garcia, PPD, part of Thermo Fisher Scientific
- Trisha Hutzul, Johnson and Johnson Clinical Operations
- Susan Knippenberg, Johnson and Johnson Clinical Operations
- Willow MacDonald, Johnson and Johnson Clinical Operations
- Dr. Susan McCune, PPD, part of Thermo Fisher Scientific
Equity by Design in Clinical Research Metrics Framework – Subject matter experts involved in other capacities
- Dr. Gniesha Y. Dinwiddie, National Institutes of Health (NIH)
- Rachael Fones, Diversity in Clinical Trials, IQVIA
- Dr. Leslie Harden, Biotechnology Innovation Organization (BIO)
- Dr. George Mensah, National Institutes of Health (NIH)
- Dr. Lola Olufemi, National Institutes of Health (NIH)
- Dr. Monica Webb Hooper, National Institutes of Health (NIH)
- Dr. Jodi Yellin, Association of American Medical Colleges (AAMC)
EQUITY BY DESIGN IN CLINICAL RESEARCH
Equity by Design in Clinical Research – Leadership
- Dr. Barbara Bierer, Faculty Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Hayat Ahmed, Project Manager, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Dr. Willyanne DeCormier Plosky, Program Manager, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Laura Meloney, Program Manager, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Sarah White, Executive Director, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Jennifer Ewing, Senior Communications Specialist, Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital & Harvard
- Dr. Timothy Rebbeck, Professor, Medical Oncology, Dana-Farber Cancer Institute
- Dr. Kristin Legor, Vice President Clinical Research Nursing Operations, Dana-Farber Cancer Institute
- Doris Sempasa, Program Manager, Center for Cancer Equity and Engagement at Dana-Farber Cancer Institute
- Richard Oakley, Director of Communications, Dana-Farber Cancer Institute
- Maxine Harney, Course Coordinator & Technical Lead for Continuing Professional Development, Mass General Brigham
Equity by Design in Clinical Research – Discussants
Module 1
- Ms. LaShell Robinson, Director for Diversity & Inclusion in Clinical Trials, Takeda Pharmaceuticals
- Dr. Ravi Thadhani, Chief Academic Officer, Mass General Brigham; Professor of Medicine and Academic Dean, Harvard Medical School
Module 2
- Dr. Narjust Duma, Associate Director, Cancer Care Equity Program, Dana-Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School
- Dr. Karen M. Emmons Professor, Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health; Faculty Director, Community Engagement Program, Harvard Catalyst
Module 3
- Dr. Nadine J. McCleary, Medical Oncologist, Department of Medical Oncology in the Center for Gastrointestinal Oncology, the Dana-Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School
- Dr. Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group (WCG)
Module 4
- Dr. Christopher S. Lathan, Chief Clinical Access and Equity Officer, Dana-Farber Cancer Institute; Christopher and Constance Hadley Family Chair, Dana-Farber Cancer Institute; Associate Medical Director, Dana-Farber Cancer Institute Network; Associate Professor of Medicine, Harvard Medical School
- Dr. Sapna S. McManus; Head of Patient Inclusion & Health Equity and Chief Diversity Officer, Genentech
Module 5
- Ms. Shannon K. Bell, Director, Workforce Planning and Development, National Cancer Institute (NCI), National Institutes of Health; Executive Coach; Co-chair, Promoting an Equitable and Inclusive NCI Community
- Dr. Valerie E. Stone, Vice-Chair for Diversity, Equity, and Inclusion, and Director of Health Equity Initiatives, Department of Medicine, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School
Module 6
- Dr. Ebony Boulware, Professor and Chief, Division of General Internal Medicine, Department of Medicine; Director, Clinical and Translational Science Institute; Vice Dean for Translational Science, Duke Clinical and Translational Science Institute, Duke University
- Dr. Lola Fashoyin-Aje, Deputy Division Director, Division of Oncology 3, Office of Oncologic Diseases, OND/CDER; Associate Director, Science and Policy to Address Health Disparities, Oncology Center of Excellence, Food and Drug Administration
