6:33 PM
Dec 17, 2012
 |  BC Extra  |  Politics & Policy

FDA issues draft guidance on trial enrichment

FDA issued draft guidance outlining enrichment strategies to improve the efficiency of clinical trials, including strategies to reduce heterogeneity, or non-drug variability. The agency, which has been working on the guidance since 2006, defines enrichment as the prospective use of patient characteristics to select a study population in which detection of a drug effect, if one is present,...

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