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Diversity, Inclusion, and Equity in Clinical Research

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

In the U.S. and abroad, regulatory approvals for investigational products are based on carefully designed, blinded, randomized clinical trials. Ideally, the participant population enrolled in clinical trials reflects the composition of the general population or of those affected by the disease, so that the research yields generalizable knowledge pertinent to the population that will use the product. As safety and efficacy of drugs and biologics can vary depending on intrinsic and extrinsic factors, including an individual’s sex, race, ethnicity, and age, clinical trials should also provide information that informs the use of therapeutic agents within identified subgroups. However, despite regulatory directives and public expectations, the composition of study populations in most clinical trials does not always reflect such characteristics in a manner that would permit analysis of treatment outcome by subgroup. This failure to achieve meaningful diversity limits information about drug response and measures of safety and efficacy in historically under-represented and under-studied populations, in particular women, diverse ethnic and racial groups, children, and the elderly.

The MRCT Center’s Diversity, Inclusion, and Equity program began in 2018 with the formation of the  ‘Diversity’ Workgroup (a dynamic group of stakeholders including academic- and industry-based leaders, not-for-profit institutional representatives, patients and patient advocates, and government representatives). Publication of the Achieving Diversity, Inclusion, Equity in Clinical Research Guidance Document in 2020 is a main output of the workgroup, but the program continues to substantiate and qualify the value of diversity, inclusion, and health equity to the science of biological variability, health care, and social justice; to explore why diverse representation has not increased despite numerous calls to action; to identify and analyze barriers that limit diverse participation; and to develop and disseminate guidance materials, tactical approaches, and tools that advance required changes to conceptual, organizational, and operational challenges in clinical research.

Current Status: Active Project

Impact:

A conceptual framework, grounded in a clear set of ethical principles, that promotes understanding of the goals of diversity, addresses current barriers to progress, and explores solutions to common scientific and sociocultural barriers to meaningful diversity in clinical trials. This is important and overdue, particularly as we witnessed the profound impact of COVID-19 on underrepresented and vulnerable populations.

Objectives:

  • Clarify the meaning and advance the goals of diverse representation of participants in clinical research by developing a statement of principles and a conceptual framework to advance an understanding of diversity in clinical trials;
  • Substantiate and qualify the value of diversity to the science of biological variability, health care, and social justice;
  • Examine variability in methods 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, including scientific, ethical, and sociopolitical challenges;
  • Identify and define potential approaches and solutions to effective recruitment and retention of under-represented participants, referring providers, investigators and their research team, clinical sites, and sponsors, and measures to help ensure accountability;
  • Develop and disseminate actionable and scalable solutions (“tools”) to promote the goal of diversity in enrollment and to facilitate subgroup analysis in clinical trials.

Key Milestones:

  • December 2017: Initial teleconference of leadership team
  • February 2018: Inaugural conference call held with the working group
  • December 2018: Panel discussion at MRCT Center Annual Meeting
  • July 2019: Submitted comments to FDA in response to draft guidance on enhancing the diversity of clinical trial populations
  • November 2019: In-person meeting of Diversity Workgroup at Harvard Faculty Club
  • December 2019: Panel Discussion at MRCT Center Annual Meeting; published Version 1.0 of Diverse Representation and Inclusion in Clinical Research – Principles
  • August 2020: MRCT Center releases Achieving Diversity, Inclusion and Equity in Clinical Research Guidance Document and launches Diversity in Clinical Research website
  • 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
  • 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
  • November 30, 2020: Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations. A virtual conference hosted by MRCT Center in collaboration with FDA.
  • January 2021: Guidance Document and supplementary Toolkit Version 1.1 available via Amazon.com
  • August 2020 – March 2021: During first eight months after release of Guidance Document and Toolkit, MRCT Center gave ~30 presentations to various audiences, some of these are listed here
  • March 2021: Published “Justice, Diversity, and Research Ethics review” in Science magazine
  • April 2021 – July 2021: Leaning In webinar series “Driving Inclusion in Clinical Research” emphasizes how to plan for inclusion, implement recommendations, and sustain progress.
  • October 2021: Published “Integrating Supported Decision-Making into the Clinical Research Process” in The American Journal of Bioethics.

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
  • 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

Program/Project Managers:

  • Hayat Ahmed, MSc.
  • Laura Meloney, MSc, MPH
  • Willyanne DeCormier Plosky, DrPH, MPH