US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development
Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.
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However, new draft guidance expressly does not address diversity action plans required under Food and Drug Omnibus Reform Act; initial guidance on these plans was due in December 2023 but has yet to be released.
Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.
New guidance is due in a few months that should answer questions about how the FDA will react if a sponsor does not reach its clinical trial diversity goals.