Diversity, Inclusion, and Equity in Clinical Research
Focus Area: Current Project
Focus Area: Ethics, Conduct, and Oversight
Ideally, the participant populations enrolled in clinical trials reflect the populations of those affected by the disease or condition for which the investigational product is being tested. However, despite regulatory directives and public expectations, there remain populations that are underrepresented in clinical trials, such as women, diverse ethnic and racial groups, people living with disabilities, children, and the elderly. The failure to achieve meaningful and appropriate representation limits both generalizable and sub-group specific information about drug response and measures of safety and efficacy.
The MRCT Center’s Diversity, Inclusion, and Equity (DEI) in Clinical Research program began in 2018 to address this challenge. In collaboration with industry-based leaders, not-for-profit institutional representatives, patients and patient advocates, and government representatives, the MRCT Center published the Achieving Diversity, Inclusion, Equity in Clinical Research Guidance Document in 2020. While significant progress has been made in the last few years, through the dedicated commitment and foundational work of many stakeholders across the clinical research enterprise, we remained attuned to that which we still need to learn and actions we need to take so the future of health equity and justice look different compared to today
The MRCT Center’s program continues to advocate for diversity and inclusion, and support joint work in conceptual, educational, analytic, operational, and policy efforts toward health equity social justice.
- Advance the goal of diverse representation of participants in clinical research by developing conceptual and methodological frameworks to advance the understanding of, and accountability for, diverse representation in clinical trials;
- Review current methods and guidance used to define, collect, analyze, utilize, and communicate clinical trial data on race, sex, ethnicity, and age;
- Describe the barriers to diverse representation in research in the U.S. and in multi-regional trials, including scientific, ethical, and sociopolitical challenges; and generate and share lessons learned about potential approaches for effective communication, recruitment, and retention of underrepresented participants;
- Support engagements and sustainable partnerships with community advocates, organizations, and referring providers, and diverse workforce development of clinical research personnel;
- Develop and disseminate actionable and scalable solutions (“tools”) to support the inclusion of diverse populations in research.
- June 2022: Held webinar to launch the Equity by Design Metrics Framework and User Guide
- June 2022: Launched IRB and HRPP Toolkit
- March-April 2022: Conducted a virtual six-part training on “Equity by Design in Clinical Research: Cancer Trials” for over 450 clinical research practitioners (live course, for CME credit; now available as online course, not for CME credit).
- March 2022: Published “Advancing the inclusion of underrepresented women in clinical research” commentary in Cell Reports Medicine.
- January 2022: Published “Promoting Equity by Design in Clinical Trials” in the Association of American Cancer Institutes (AACI) Commentary.
- October 2021: Published “Integrating Supported Decision-Making into the Clinical Research Process” in The American Journal of Bioethics.
- April 2021 – July 2021: Leaning In webinar series “Driving Inclusion in Clinical Research” emphasizes how to plan for inclusion, implement recommendations, and sustain progress.
- March 2021: Published “Justice, Diversity, and Research Ethics review” in Science magazine
- January 2021: Guidance Document and supplementary Toolkit Version 1.1 available via Amazon.com
- November 2020: Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations. A virtual conference hosted by MRCT Center in collaboration with FDA.
- September 2020: Webinar with FDA Office of Minority Health and Health Equity to launch MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Toolkit
- October 2020 – February 2021: Leaning In webinar series “Practical Approaches to Improving Diversity in Clinical Trials” focuses on concrete strategies and shared experiences for improving diversity in clinical trials
- August 2020: MRCT Center releases Achieving Diversity, Inclusion and Equity in Clinical Research Guidance Document and launches Diversity in Clinical Research website
- December 2019: Panel Discussion at MRCT Center Annual Meeting; published Version 1.0 of Diverse Representation and Inclusion in Clinical Research – Principles
- November 2019: In-person meeting of Diversity Workgroup at Harvard Faculty Club
- July 2019: Submitted comments to FDA in response to draft guidance on enhancing the diversity of clinical trial populations
- February 2018: Inaugural conference call held with the working group
- RADM Richardae Araojo, PharmD, MSc. Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, US FDA
- Barbara Bierer, MD. Faculty Director, MRCT Center
- Luther Clark, MD, FACC, FACP. Deputy Chief Patient Officer, Merck
- Milena Lolic, MD, MS. Lead Medical Officer, US FDA
- David Strauss, MD. Senior Advisor, MRCT Center
- Sarah White, MPH. Executive Director, MRCT Center
- Hayat Ahmed, MSc.
- Willyanne DeCormier Plosky, DrPH, MPH