Clinical Trial Diversity: ‘How Much More Evidence Do We Need To Move Forward?’
This article was originally published in The Pink Sheet Daily
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.
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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.
Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.