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# Noninferiority Trials Can Identify Innovations: Study
- URL: https://www.fdaweb.com/noninferiority-trials-can-identify-innovations-study/
- Published: 2017-10-05T12:00:00.000Z
- Updated: 2026-09-14T22:54:15.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5139801

Harvard Medical School researchers say that noninferiority clinical trial designs are being applied more commonly and broadly and when appropriately designed and executed can identify innovative treatment alternatives with clinical value. [Writing](http://www.nejm.org/doi/full/10.1056/NEJMra1510063?rss=searchAndBrowse&ref=fdaweb.com) in the *New England Journal of Medicine*, the authors say that noninferiority trials “have become a major tool for the evaluation of drugs, devices, biologics, and other medical treatments.”

The article provides a framework for considering the features, including pitfalls, or noninferiority studies. It uses cardiovascular treatment trials as examples, while acknowledging that noninferiority trials can be conducted in many fields.

Suggestions the authors make for improving noninferiority trials include: providing an explicit justification of the acceptable margin that is based on a measurement or anticipated benefit of the experimental treatment, being cautious when considering composite endpoints that may include components with discordant benefits and risks, and strongly considering sensitivity analysis regarding missing data in the planning and analysis of noninferiority trials.