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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.

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, 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.

Key Milestones:

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.
  • Willyanne DeCormier Plosky, DrPH, MPH