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# Guidance on Non-inferiority Trials
- URL: https://www.fdaweb.com/guidance-on-non-inferiority-trials/
- Published: 2016-11-09T12:00:00.000Z
- Updated: 2026-09-14T21:46:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137302

*Federal Register* Notice: FDA has made available a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness.” The document discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. It says that a non-inferiority design is usually used because a superiority study design (drug versus placebo, dose response, or superiority to an active drug) cannot be used. It also gives advice on when non-inferiority (NI) studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-08/pdf/2016-26931.pdf?ref=fdaweb.com).