Diversity, Inclusion, and Equity in Clinical Research Project-Specific Website
Explore our interactive project-specific website focusing on innovative and practical measures to increase diverse and inclusive representation in the clinical research enterprise.
Diversity, Inclusion, and Equity in Clinical Research
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, sexual and gender minorities, 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 and Toolkit in 2020. In 2022, the MRCT Center published the IRB and HRPP [DEI] Toolkit, and in 2023 the Accessibility by Design in Clinical Research Toolkit. 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.
Click Here to Access our Interactive Project Specific Website
OBJECTIVES
- 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, ethnicity, sex, gender identity, sexual orientation, age, disability, and other factors;
- 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.
KeY MILESTONES
- August 2023: Published a Delphi consensus statement: Review of Diversity, Equity, and Inclusion by Ethics Committees in Med (Cell Press)
- May 2023: Released the Accessibility by Design (AbD) Toolkit at a webinar.
- March 2023: Published Data Visualization Explorer: A Tool for Participant Representation in Patterns
- October 2022: Published Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarity and Justification in Health Affairs
- 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: “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and supplementary Toolkit Version 1.1 (first launched in September 2020 via a webinar with FDA Office of Minority Health and Health Equity) 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
project Leadership & sTAFF
- Barbara Bierer, MD. Faculty Director, MRCT Center
- Sarah White, MPH. Executive Director, MRCT Center
- Hayat Ahmed, MSc. Program Manager, MRCT Center
- Willyanne DeCormier Plosky, DrPH, MPH. Program Director, MRCT Center
Former Project Leadership:
- RADM Richardae Araojo, PharmD, MSc. Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, US FDA
- 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
Project Resources
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Webinar
March 7, 2024
REACH: Advancing DEI in Human Participant Research ›
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Public Comments
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Public Comments
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Public Comments
November 10, 2023
Comment on the American Community Survey SOGI Test ›
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Public Comments
September 30, 2023
Comments and Suggestions on Updating the NIH Mission Statement ›
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Publication
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Publication
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Publication
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Publication
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Flyer
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Publication
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Webinar
May 4, 2023
Accessibility by Design (AbD) Toolkit Release ›
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Tools
May 4, 2023
Accessibility by Design (AbD) Toolkit ›
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Publication
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Annual Report
December 15, 2022
2022 MRCT Center Annual Report ›
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Proceedings
December 14, 2022
MRCT Center 2022 Annual Meeting Proceedings ›
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MRCT Sponsor Resource
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Presentation
December 14, 2022
MRCT Center 2022 Annual Meeting Slides ›
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Publication
December 7, 2022
Protecting the Vulnerable and Including the Under-Represented ›
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Publication
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Publication
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Public Comments
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Tools
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Publication
September 28, 2022
Externalist, Process-Based Approach to Supported Decision-Making ›
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Webinar
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Presentation
July 14, 2022
Equitable Practices for Children’s Vision Research ›
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Publication
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Video
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Webinar
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Webinar
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Presentation
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Presentation
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Framework
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Tools
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Tools
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Publication
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Tools
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Tools
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Tools
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Tools
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Tools
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Tools
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Tools
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Tools
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Tools
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Tools
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Public Comments
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Training
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Publication
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Publication
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Publication
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Publication
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Publication
January 1, 2022
Promoting Equity By Design In Cancer Trials ›
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Annual Report
December 7, 2021
2021 MRCT Center Impact Report ›
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Publication
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Webinar
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Presentation
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Webinar
January 13, 2021
MRCT Center Leaning In webinar: Data Standards and Analysis ›
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Annual Report
December 20, 2020
2020 MRCT Center Impact Report ›
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Webinar
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Proceedings
December 3, 2020
MRCT Center 2020 Annual Meeting Proceedings ›
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Presentation
December 3, 2020
MRCT Center 2020 Annual Meeting Slides Part 1 ›
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Presentation
December 3, 2020
MRCT Center 2020 Annual Meeting Slides Part 2 ›
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Webinar
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Publication
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Webinar
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Webinar
November 10, 2020
PRIM&R WEBINAR: “THE IRB’S ROLE IN ACHIEVING DIVERSITY IN RESEARCH” ›
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Presentation
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Webinar
October 28, 2020
MRCT Center Leaning In webinar: Workforce Development ›
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Presentation
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Webinar
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Webinar
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Webinar
October 14, 2020
MRCT Center Leaning In Webinar Series ›
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Publication
September 29, 2020
Emerging work on Diversity & Clinical Trials: A Spotlight on the MRCT ›
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Presentation
September 23, 2020
The Way Forward: From ‘diagnosis’ to ‘treatment’ of COVID-19 ›
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Presentation
September 22, 2020
Achieving Diversity, Inclusion, and Equity In Clinical Research ›
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Publication
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Podcast
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Podcast
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Podcast
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Principles
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Tools
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Framework
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Framework
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Framework
August 1, 2020
Defining Diversity ›
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Tools
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Tools
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Tools
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Tools
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Tools
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Case Study
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Case Study
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Case Study
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Tools
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Guidance
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Tools
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Public Comments
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Presentation
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Tools
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Publication
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Annual Report
December 4, 2019
2019 MRCT Center Impact Report ›
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Principles
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Presentation
October 29, 2019
Evolving science in clinical trials in special populations ›
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Tools
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Tools
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Presentation
October 8, 2019
Efficiencies in Clinical Research: A USA perspective ›
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Presentation
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Presentation
October 3, 2019
A USA perspective on diversity and inclusion ›
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Tools
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Public Comments
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Public Comments
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Other
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Annual Report
December 5, 2018
2018 MRCT Center Impact Report ›
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Presentation
November 15, 2018
Does Diversity Matter in the Conduct of a Clinical Trial? ›
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Project-Specific Website