Drugs

Trial Enrichment Strategies Guidance

FDA has published a guidance, Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products, to increase the efficiency of drug development and support precision medicine. The document also discusses design options for enrichment strategies and discusses interpretation of the results of studies that use enrichment strategies.

“Enrichment is the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population,” the guidance says. “Although this guidance focuses on enrichment directed at improving the ability of a study to detect a drug’s effectiveness, similar strategies can be used in safety assessments.”

Three broad categories of enrichment strategies addressed in the guidance are strategies to decrease variability, prognostic enrichment strategies, and predictive enrichment strategies.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome