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Regulatory Guidance

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Multiplicity guidance

Committee for Proprietary Medicinal Products (European Medicines Agency). Points to consider on multiplicity issues in clinical trials. September 2002. Download.

Committee for Medicinal Products for Human Use (European Medicines Agency). Concept paper on the need for a guideline on multiplicity issues in clinical trials. May 2012. Download.

U.S. Food and Drug Administration. Guidance for industry: Multiple endpoints in clinical trials. Expected to be released in Summer 2013.

Enrichment guidance

U.S. Food and Drug Administration. Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products. December 2012. Download.

Adaptive design guidance

Committee for Medicinal Products for Human Use (European Medicines Agency). Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. October 2007. Download.

U.S. Food and Drug Administration. Guidance for industry: Adaptive design clinical trials for drugs and biologics. February 2010. Download.