Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups

Jun 26 2024

• By Sarah Karlin-Smith

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New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline.

overflowing coffee cup with coffee spilled on table — While greater than proportional enrollment may be necessary, the FDA will not conduct statistical testing on population subgroups. • Source: Shutterstock

Drug and medical device sponsors may need to overenroll key patient populations under the US Food and Drug Administration’s new diversity action plan guidance, a move that could make the revamped clinical trial diversity push more challenging than anticipated.

Key Takeaways

Aiming high for diversity, the FDA says greater than proportional enrollment for some subpopulations may be warranted as targets in soon-to-be required diversity action plans, but says it would not do statistical testing on population subgroups.

The 2022 Food and Drug Omnibus Reform Act (FDORA) implemented a requirement for sponsors to submit “diversity action plans” for...

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