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Enriched Trials Not Just About Marker-Positive Patients, FDA Says

 
• By Cathy Dombrowski

Without clear-cut evidence that a drug will not work in patients without a predictive marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.

Information about a drug’s effect in patients without a characteristic that predicts efficacy can be just as important as the data for those with the predictive marker when trying to prove that marker’s value.

FDA makes this case in its draft guidance on “Enrichment Strategies for Clinical Trials To Support Approval of...

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