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Multiple Endpoints In Clinical Trials: US FDA Advises How To Avoid False Positives

 
• By Brenda Sandburg

Draft guidance suggests ways to control for erroneous conclusions when there are multiple analyses of a drug’s effects.

Yellow road sign with a blue sky and white clouds: clinical trial

FDA has issued a draft guidance to help sponsors avoid reaching false conclusions about a drug’s effects in clinical trials with multiple endpoints.

The draft guidance, Multiple Endpoints in Clinical Trials, describes strategies for grouping and ordering endpoints for analysis and applying statistical methods for managing multiplicity within a study to...

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