How AI can help satisfy FDA’s drug, device diversity requirements – STAT

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The Food and Drug Omnibus Reform Act of 2022 (FDORA), which was passed as part of the Consolidated Appropriations Act of 2023, will encourage greater diversity in clinical trials and help ensure new medications and treatments are developed with more representative populations in mind. But FDORA represents a paradigm shift for life sciences companies in the way individuals will be identified for clinical trials and enrolled in them, requiring companies to look closely at and rethink their current trial strategies.

FDORA will require trial sponsors to include diversity action plans for Phase 3 and other pivotal studies of new drugs and devices to contribute to more generalizable clinical data, which can improve both regulatory decisions and public health.


While the date these regulations will go into effect remains to be determined (at the time this article was published, the FDA had not set the expected date of its updated guidance), the mandates for change are clear: Trials that start enrolling participants after the effective date will be required to include a diverse patient population, with a focus on racial and ethnic diversity. Other demographic and non-demographic factors — including sex, gender identity, age, pregnancy status, lactation status, and multiple comorbidities — will also need to be considered.

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