With new diversity guidance, EHR data plus AI will be critical

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In June 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the need for “Diversity Action Plans” as a way for clinical trial sponsors to demonstrate their consideration toward trial representation. Affecting phase 3 studies, and others as appropriate, the guidance iterates on a previous draft from 2022 borne from the Food and Drug Omnibus Reform Act (FDORA) that same year.

As sponsors plan their compliance with this near-final guidance, they’re likely to rethink their protocol development process more systemically—or at least, they should, experts say.

For the brands including big pharma that tend to work from libraries of global protocol templates with pre-established inclusion and exclusion criteria, the guidance will likely...

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