FDA Issues New Guidelines On Clinical Trial Enrichment

Law360, New York (December 17, 2012, 5:59 PM EST) -- The U.S. Food and Drug Administration on Monday released draft guidelines on how drug companies can select certain patient populations for clinical trials, a method known as enrichment that FDA officials said could lead to smaller studies, lower development costs and help develop more personalized medicine.

The draft guidance document lays out strategies for both prognostic enrichment, which is the selection of patients at the highest risk for conditions a drug is meant to treat, and predictive enrichment, which aims to identify patients more likely to...
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