Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance titled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies" to aid medical product sponsors in creating Diversity Action Plans (DAPs) for clinical studies. Stakeholders can submit comments on the draft guidance until September 26, 2024.
The draft guidance outlines the format and content of DAPs, as required by the Food and Drug Omnibus Reform Act (FDORA) of 2022. This updated version replaces a similar draft from April 2022 and details which medical products and clinical studies necessitate a DAP, the submission process, and the criteria the FDA will use to evaluate waiver requests.
Focus on Representation
DAPs aim to increase the enrollment of historically underrepresented populations to improve the data the agency receives about potential users of medical products. Esther Krofah, Executive Vice President of Health at the Milken Institute, noted that the DAP focuses on the rate of representation from underrepresented groups based on race, ethnicity, sex, and age, rather than just raw numbers.
According to the guidance, DAPs must specify the sponsor’s rationale and goals for clinical study enrollment, separated by age group, ethnicity, sex, and race of clinically relevant study populations. Sponsors are also urged to consider dimensions beyond these factors to enroll populations that represent the patients who will be treated if the product is approved.
Sponsor Responsibilities and Modifications
Krofah emphasized that the DAP is a "plan" requiring significant thought from both the FDA and industry. Companies may vary in their preparedness, with some having already invested considerable effort since FDORA's passage. She added that this is an opportunity for stakeholders to invest in clinical research infrastructures to recruit and retain those historically excluded from clinical research, leveraging available data and technologies for recruitment and retention strategies.
DAPs apply to Phase 3 clinical studies or pivotal clinical studies of drugs or biological products, as well as certain device studies intended for safety and effectiveness evaluations. The DAP requirement applies to clinical studies starting enrollment 180 days after the final guidance is published.
Diversity Action Plans can be modified in response to FDA feedback or the sponsor’s initiative. The guidance suggests that if original plan goals are unmet, an explanation should be provided, including reasons for not meeting enrollment goals and plans to mitigate such outcomes.
Public Engagement and Transparency
The FDA encourages sponsors to share their strategies for meeting DAP enrollment goals with the public in consumer-friendly language, publicly posting enrollment goals and planned measures.
Krofah is optimistic about the positive impact of DAPs on trial diversity, and the Milken Institute plans to submit comments to the FDA suggesting refinements to maximize the plans' potential.
Krofah stated that the FDA aims to work with sponsors to approve medical products if requirements are met and evidence supports the product's safety and effectiveness for intended populations. She emphasized that DAP implementation should align with governmental and sponsor investment in clinical research infrastructure and payer reimbursement to recruit and retain historically underrepresented communities. The annual report to Congress, as described in FDORA Section 504, is crucial for holding all stakeholders accountable for implementing DAPs for safe and effective medical products for all people. Continued demonstration by the FDA of how DAPs inform safety and efficacy decisions based on populations experiencing disease prevalence in the real world will drive progress in this area.
