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FDA Requirement for Clinical Trial Diversity Action Plans: Are They Useful?
(Thursday, January 26, 2023) Clinical trial sponsors are required to create and implement trial-specific “Race and Ethnicity Diversity Plan” for patient recruitment intended to promote diversity of the subject populations in all stages of their clinical trials. However, these plans have had limited impact on most clinical trials as shown by review of the patient populations included in clinical trials for products approved by the FDA year after year. Ethnic and racial minorities are grossly underrepresented in clinical trials conducted in the US. Last year FDA released a guidance document to specify the content of the diversity action plans (DAP). The DAP must describe how the sponsor plans to recruit and retain a diverse population of participants in the trial, including individuals from underrepresented racial and ethnic minorities, individuals from diverse gender identities, individuals from diverse socioeconomic backgrounds, and individuals from diverse geographic regions. The guidance requires that sponsors submit annual progress reports on the implementation of their diversity action plans. These reports must include data on the demographic characteristics of the trial participants, as well as any challenges or successes in recruiting and retaining a diverse population of participants. The FDA also encourages sponsors to work closely with community-based organizations and patient advocacy groups to ensure that the recruitment and retention efforts are inclusive and effective. A formal DAP must be submitted as a part of the IND for ongoing efforts and the NDA/BLA to document the success or challenges with those efforts resulting in the final patient populations included in the market approval application. While the intent and efforts to include diverse populations is clear, the results show that these by themselves are not sufficient to induce poorly represented ethnicities to participate in clinical trials. The FDA guidance emphasizes the importance of involving community-based organizations, collection and analysis of relevant racial and ethnic data for a given trial population, broadening of eligibility criteria with appropriate scientific justification, offering higher financial compensation, covering patient support such as the cost of the accompanying care-givers, providing language/cultural support, and increasing awareness of the state-of-the-art therapies and care available through the clinical trials. The Diversity Action Plan is a good start, but it requires multi-dimensional perspective and implementation. There is still a lot of work to do. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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