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Clinical Trial Enrichment Could Require Post-Market Studies, Labeling To Address Shortcomings

 
• By Cathy Dombrowski

FDA’s guidance on clinical trial enrichment notes that a lack of information on patients without the enrichment characteristic may result in Phase IV studies to characterize a drug’s safety and efficacy in a broader population.

Sponsors who base an NDA primarily or solely on clinical trials with enriched populations could face a possible post-market commitment or requirement to better define the drug’s effect in a broader population.

FDA always considers the extent of data on subgroups without the enrichment characteristic and may request Phase IV trials to gather more information to characterize the drug’s safety and efficacy...

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More from North America

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