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# Multiple Clinical Trial Endpoints Guidance
- URL: https://www.fdaweb.com/multiple-clinical-trial-endpoints-guidance/
- Published: 2022-10-20T12:00:00.000Z
- Updated: 2026-09-14T18:03:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153014

FDA has published a guidance, *Multiple Endpoints in Clinical Trials*, presenting the agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how they can be managed in clinical trials for human drugs and biologics. The [document](https://www.fda.gov/media/162416/download?ref=fdaweb.com) says that when more than one endpoint is analyzed in a single trial, the likelihood of making false conclusions about a drug’s effects due to one or more of the endpoints could increase if there is no appropriate adjustment for multiplicity.

“The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis of a drug’s effects and applying some well-recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug’s effects,” it says. “Basing a conclusion on an analysis where the risk of false conclusions has not been appropriately controlled can lead to false or misleading representations regarding a drug’s effects.”

FDA says issuing the guidance is a partial fulfillment of an agency commitment under the FDA Amendments Act of 2007.

The guidance includes Introduction, Scope, Multiple Endpoints: General Principles, Methodological Considerations, Summary, and General References.