The AAMC submitted a June 13 letter to the Food and Drug Administration (FDA) in response to the agency’s request for comments on its efforts to develop plans to enroll more participants from underrepresented racial and ethnic populations in the United States into clinical trials, recommending sponsors develop a race and ethnicity diversity plan. This draft guidance (Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials) expands on the FDA’s previous efforts to increase enrollment of underrepresented populations in clinical trials, including activities related to the collection and use of patient experience data to inform regulatory decision making (refer to Washington Highlights, Sept. 14, 2018) and the collection of race and ethnicity data (refer to Washington Highlights, Oct. 28, 2016)
The AAMC’s comments commended the agency’s interest in ensuring sponsors take meaningful steps to increase underrepresented populations in clinical trials, especially during a time when the administration is focused on advancing equity across the federal government in furtherance of executive order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. The AAMC and the AAMC Center for Health Justice recognized that addressing the underrepresentation of populations in research is a complicated issue, and any diversity plan to improve enrollment and retention should include robust coordination and engagement with individuals and communities that are closest to injustice and inequity. Among other recommendations, the AAMC suggested the FDA take the following steps in furtherance of the proposed guidance:
- Increase coordination with the FDA Office of Patient Affairs to streamline patient engagement efforts and a broad interagency approach.
- Encourage sponsors to solicit community input to assist with enrollment and retention activities, as well as the development of the diversity plan itself.
- Reconsider the timeline associated with sponsor submission of a diversity plan to the FDA, recommending submission well in advance of the formal End-of-Phase 2A meeting so that safety and efficacy issues are prudently addressed.
- Reconsider reliance on the Office of Management and Budget’s (OMB) guidance on Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, which has not been updated since 1977. Reliance on antiquated standards increases the potential for bias and discrimination in the context of drug and device performance. Instead, coordinate with the OMB’s current efforts to develop updated guidance on this issue (refer to Recommendations from the Equitable Data Working Group, published this April).
- Consider additional factors and determinants in addition to race and ethnicity, including the intersection and impact of underacknowledged determinants in underserved communities.
The AAMC expressed strong support for the FDA’s interest in promoting diversity in clinical trials, offering an introduction to the Center for Health Justice’s multisector partners to assist the agency with this draft guidance and broader commitment to collect comprehensive patient input.