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January 26, 2022

Challenges in the Design, Registration, and Reporting of Noninferiority Trials

Author Affiliations
  • 1Department of Clinical Epidemiology, Leiden University Medical Center (LUMC), Leiden, the Netherlands
  • 2Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands
JAMA Psychiatry. 2022;79(3):191-192. doi:10.1001/jamapsychiatry.2021.3932

In superiority trials, usually researchers expect that the treatment of interest is more effective (superior) compared with placebo or an active comparator treatment. To demonstrate superiority, a null hypothesis is defined that usually states that the outcomes are the same in the treatment arms. Convincing evidence against that hypothesis (often based on a P value that is less than a predefined threshold, eg, .05) would lead researchers to reject the null hypothesis and thus conclude that one treatment is better than the other. Therefore, in a superiority trial that provides convincing evidence that an experimental treatment is superior to placebo (or active comparator), conclusions about (relative) efficacy can be drawn.

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