Enrichment Guidance To Prod Sponsors Toward Prospective Patient Stratification
The sensitivity and specificity of the target identification could determine size of the off-target population, CDER senior statistical advisor Robert O’Neill says at DIA/FDA meeting on revitalizing R&D.
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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marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.
A Center for Devices and Radiological Health representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.
FDA released long-awaited draft guidance on the development of drugs with companion diagnostics July 12, but the 12-page document’s concise nature left some in the industry longing for more insight.