In a significant move to address longstanding issues of underrepresentation in medical research, the U.S. Food and Drug Administration (FDA) has released a draft guidance document aimed at increasing diversity in clinical trials. This much-anticipated guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” provides detailed recommendations for sponsors of drug and medical device trials. The plans were mandated by the passage of the Food and Drug Omnibus Reform Act (FDORA) in 2022, highlighting the legislative push to improve diversity in clinical research.

Key highlights of the guidance include:

  1. Mandatory Diversity Action Plans: As required by FDORA, sponsors will need to submit Diversity Action Plans for certain clinical studies, including phase 3 drug trials and pivotal device studies. These plans must specify enrollment goals disaggregated by race, ethnicity, sex, and age group.
  2. Enrollment Goals and Rationale: Sponsors must provide clear enrollment targets for underrepresented groups and justify these goals based on disease prevalence, potential for differential effects, and other relevant factors.
  3. Strategies for Achieving Diversity: The guidance outlines various approaches sponsors can take to meet enrollment goals, such as community engagement, reducing participant burden, and improving study accessibility.
  4. Timeline for Implementation: The requirements will apply to clinical studies commencing enrollment 180 days after the publication of the final guidance.
  5. Transparency Measures: FDA encourages sponsors to publicly share key information from their Diversity Action Plans to promote transparency and potentially aid in recruitment.

This guidance represents a significant step forward in the FDA’s efforts to ensure that clinical trial populations better reflect the diversity of patients who will ultimately use medical products. By providing a structured framework for addressing underrepresentation, the agency aims to improve the generalizability of clinical trial results and enhance our understanding of how medical products perform across different populations.

The implementation of these Diversity Action Plans, as mandated by FDORA, demonstrates a concerted effort by both legislators and regulators to address the critical issue of diversity in clinical trials. This approach combines legislative action with regulatory guidance to drive meaningful change in the conduct of medical research.

As this is a draft guidance, the FDA is seeking public comments for the next 90 days. Once finalized, this document will play a crucial role in shaping the future landscape of clinical research, potentially leading to more equitable and representative medical product development.

The release of this guidance coincides with broader efforts to address diversity in clinical trials, including initiatives from the White House and other stakeholders in the healthcare and research communities.