Representation in Research – The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

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, different ethnic and racial groups, sexual and gender minorities, people living with disabilities, the elderly, and people living in rural areas. The failure to achieve appropriate representation limits both generalizable and sub-group-specific information about drug response and measures of safety and efficacy.

The MRCT Center’s Representation in Clinical Research program began in 2018 to address this challenge, publishing the Achieving Diversity, Inclusion, Equity in Clinical Research Guidance Document and Toolkit in 2020., the IRB and HRPP [DEI] Toolkit in 2022, and the Accessibility by Design in Clinical Research Toolkit in 2023. 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.

Underrepresented populations (in general) People who are LGBTQIA+ Pregnant and lactating people Financial neutrality for trial participation DEI resources for IRBs/HRPPs People with disabilities People who do not speak English Global DEI

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

October 2024: Accessibility 101 Training Series
June 2024: Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design webinar
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

Willyanne DeCormier Plosky, Program Director, MRCT Center
Hayat Ahmed, Program Manager, MRCT Center
Barbara Bierer, Faculty Director, MRCT Center

Project Resources

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

October 2024: Accessibility 101 Training Series
June 2024: Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design webinar
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

CLINICAL TRIALS & RESEARCH

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