CLINICAL TRIALS & RESEARCH
Our Work

Representation in Research

Representation in Research

The participant populations enrolled in clinical trials should reflect the populations affected by the disease or condition for which the intervention is being tested. Representation in research is fundamental to good science. Everyone should be able to “see themselves” in clinical trials and research data and to understand whether approved vaccines, therapies, devices, and medications (including medication doses) are appropriate for them. Without proper representation of the people who will use the tested products, we cannot determine how safe or effective those products are for different individuals (e.g., people of varying ages, sexes, genders, body types, genetic backgrounds, co-existing health conditions, income levels, environmental exposures, and/or life stages). 

Despite efforts, there is still a great deal to learn as we work toward greater access to clinical trials and improved health outcomes. The barriers that potential participants face in finding and accessing clinical trials differ, as do the approaches that might mitigate these challenges. For some people, reducing the burden of participation through the introduction of decentralized elements is helpful; for others, it involves translation, communication (e.g., plain language, visualization), reimbursement, community and caregiver involvement, among other approaches. And, while the MRCT Center released guidance and tools to address representation in research early in the COVID pandemic, we continue to learn more about the specific ways that people from different populations can best be supported to participate in clinical research.

Our work continues, and we remain committed to it. We are continually expanding our portfolio of tools and resources. Our aim is for everyone to have a “fair shot,” both in terms of the opportunity to participate in clinical trials and in terms of being able to trust the results of that research, conducted through rigorous and ethical research practices.


DEI people DEI people DEI people DEI people DEI people DEI people DEI people DEI people DEI people
Global populations/People living outside the US Resources for IRB/HRPP members Resources for IRB/HRPP members Limited English Proficiency (LEP) populations Disabled populations/People with disabilities Disabled populations/People with disabilities Disabled populations/People with disabilities LGBTQIA+ populations LGBTQIA+ populations Financially challenged and underinsured populations Financially challenged and underinsured populations Financially challenged and underinsured populations Underrepresented Populations in General Underrepresented Populations in General Underrepresented Populations in General Disabled populations/People with disabilities Disabled populations/People with disabilities Disabled populations/People with disabilities with disabilities

Objectives

  • Describe the obstacles potential participants are facing in accessing U.S. and multi-regional clinical trials, including scientific, ethical, and geographical challenges; and generate and share lessons learned about potential approaches for effective communication, recruitment, and retention of participants from a variety of backgrounds.
  • Support engagements and sustainable partnerships with community champions, organizations, and referring providers, and workforce development of clinical research personnel. Develop and disseminate actionable and scalable solutions (“tools”) to support representation in research, greater access to clinical trials, and improved health outcomes.

Key Milestones

Project Leadership & Staff

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

Project Resources