Article | May 24, 2017

FDA Guidance On Non-Inferiority Clinical Trials To Establish Effectiveness

Source: Rho
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By Heather Kopetskie, MS, Rho

FDA Guidance On Non-Inferiority Clinical Trials To Establish Effectiveness

In November 2016 the FDA released final guidance on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. The guidance does not provide recommendations for how to evaluate the safety of a drug using a non-inferiority trial design. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.