Some issues for the evaluation of non-inferiority trials

What is it about?

We have proposed 14 questions to assist in evaluating the clinical evidence of the experimental versus standard therapy. The aim of these questions is to critically appraise non-inferiority trials (NITs) and support proper interpretation of study results.

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Why is it important?

Although publications exist on guidance for NIT methodology, study design, and reporting, we are not aware of many articles that assess the quality or generalizability of NITs. We have proposed 14 questions to assist in evaluating the clinical evidence of the experimental versus standard therapy. The aim of these questions is to critically appraise NITs and support proper interpretation of study results. While we focused on features of NITs, some questions are also applicable to superiority trials, but the implications of these questions may be different between superiority trials and NITs. We also omitted some shared features found in superiority trials, such as the appropriateness of randomization and blinding. To conclude non-inferiority conceptually is to synthesize evidence from both the current NIT comparing experimental therapy with standard therapy, and historical data comparing standard therapy with placebo control. Therefore, in principle, readers should explore external data sources to validate the current NIT.

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