FDA Carrots And Sticks Are Best Way To Get Subgroup Data, Advocates Say
Stakeholders tell FDA it should force sponsors to recruit more diverse populations for its clinical trials by refusing to approve applications with inadequate data or expediting those with the necessary information.
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Requiring that underrepresented populations be enrolled based upon disease prevalence is only way to ensure adequate diversity, some stakeholders say; agency continues to prefer more flexible approach offered by guidance, and PhRMA says mandates would lengthen development timelines for new drugs.
FDA seeks research ideas and plans to include demographic subgroup analyses in review templates as some stakeholders call for bolder action to change how companies conduct clinical trials.
Data will be presented on dedicated website as part of a new action plan to enhance demographic subgroup data collection in clinical trials.