AAMC Submits Letter to FDA on Clinical Trial Diversity Action Plans

The AAMC submitted a Sept. 26 letter (PDF)to the Food and Drug Administration (FDA) in response to anticipated draft guidanceonDiversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance outlines the recommended format and content of Diversity Action Plans and describes the process for clinical trial sponsors to submit these plans to the FDA. Congress granted the FDA in 2022 the authority to mandate Diversity Action Plans for certain clinical studies through the Food and Drug Omnibus Reform Act of 2022 (H.R. 7667), which was included as part of the Consolidated Appropriations Act, 2023 (P.L. 117-328). This new draft guidance will replace the FDA's previous draft guidance from April 2022, entitled Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials [refer to Washington Highlights, June 24, 2022].

The AAMC's letter recommended that the FDA ensure the draft guidance reflects the recent changes to the Office of Management and Budget Statistical Policy Directive 15 [refer to Washington Highlights, April 21, 2023]. Additional recommendations included expanding the scope of the draft guidance to incorporate additional factors beyond race and ethnicity, such as social determinants of health as well as sexual orientation and gender identity data, and noted explicit strategies for community-engaged enrollment and retention as highlighted in the AAMC Center for Health Justice Principles of Trustworthiness.