Clinical Trial Diversity: ‘How Much More Evidence Do We Need To Move Forward?’

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.

FDA is asking for public comments on what could be done to improve the participation of racial and ethnic demographic subgroup populations in clinical trials, but the effort may not satisfy some stakeholders who want the agency to be more aggressive in encouraging broader enrollment.

In a Federal Register notice slated for publication on Feb

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