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I'm interested in hearing the forum's thoughts and interpretation on the latest FDA draft guidance on improving enrollment of participants from underrepresented racial and ethnic populations (
link) with respect to submitting a Diversity Plan. Specifically, the impact it will have on programs already in late development (Phase 2 and beyond). Are your development teams talking about preparing and submitting them for these later stage programs (despite it being a recommendation and despite this being a draft guidance)? What do you think will be the risks for those sponsors who elect
not to provide a Diversity Plan, either because an EOP2 meeting has already occurred or P3 trials are already underway?