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

14 Dec 2012

• 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...