In April 2022, the FDA mandated that all Phase 3 and pivotal studies include a Diversity Action Plan (DAP) to ensure the representation of historically underrepresented populations in clinical trials. This requirement, codified in the Food and Drug Omnibus Reform Act of 2022, emphasizes the need for diverse enrollment in drug and device trials. By August 2023, the FDA further emphasized this by requiring post-market trials to gather data on underrepresented groups if not done premarket.
However, the FDA’s guidance could be more prescriptive, leading to uncertainty among clinical program teams about how to create and implement a DAP effectively. With clear guidelines, there’s a risk of adequate plans that fail to meet FDA standards. A successful DAP involves collaboration across various functions, including clinical operations, patient advocacy, regulatory, and more, ensuring a comprehensive and operational strategy.
Tactics like expanding site feasibility criteria to include potential recruitment from underrepresented groups can demonstrate a sponsor’s commitment to diversity and meet FDA requirements. Engaging partners in marginalized communities is crucial, necessitating a relational approach and adequate timeline planning. Teams must assess their capabilities and understand the needs for a successful DAP, possibly requiring external expertise. This approach meets regulatory expectations and aligns with the ethical obligation for inclusivity in clinical research.
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[Source: Clinical Leader, December 7th, 2023]