FDA–2021–D–0789 Diversity Plans to Improve Enrollment of Participants from
Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry
Published June 21, 2022
On Monday, June 13, the Alliance for Aging Research submitted comments to the Food and Drug Administration (FDA), responding to their draft guidance for industry on creating a Racial and Ethnic Diversity Plan for clinical trials. In the letter, the Alliance commended the FDA on their increased focus on promoting diversity within clinical trials; a necessary goal not just for understanding the efficacy of medical treatments, but also for establishing public trust.
The Alliance recommended that when clinical trial sponsors create a Racial and Ethnic Diversity Plan, they should look to do the following:
- Develop strategies for the inclusion of subpopulations within under-represented minority (URM) communities; subcategories can include age, gender, multiracial participants, and those races not identified in the US census. This will allow physicians to make the most informed recommendations and find the best therapeutic devices for their specific patients, especially in the growing area of precision medicine.
- Hire clinical trial investigators that are representative of the communities they serve. Racially and ethnically diverse investigators and staff can serve as community ambassadors, increase trust among potential study participants, and ensure that clinical trials are both culturally competent and culturally empathetic.
- Ensure that trial participants are guaranteed access to medical intervention following the end of the trial, should the medication or device prove effective and continued use prove necessary for trial participants.
- Increase accessibility of trials by utilizing telemedicine, covering the routine and ancillary trial costs, and bringing trials to URM communities by establishing positive relationships with community leaders such as cultural ambassadors, faith-based organizations, local governments, and learning institutions like universities and libraries.
- Engage patient advocacy organizations for meaningful feedback on study design and to recruit URM trial participants from their constituencies.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org.