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Non-inferiority Failure — SCE Medical Oncology MCQ

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ModerateClinical Trials & StatisticsNon-inferiority FailureSCE Medical Oncology

A researcher is asked about the difference between 'superiority' and 'non-inferiority' trial designs. In a non-inferiority trial, failure to demonstrate non-inferiority means what?

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Correct answer: D — Failure to demonstrate non-inferiority means the trial is INCONCLUSIVE — it does NOT prove inferiority; the CI for the treatment difference includes both the non-inferiority margin AND values compatible with equivalent or superior efficacy

Non-inferiority failure = inconclusive (CI crosses the non-inferiority margin). Does NOT prove inferiority. To prove inferiority, the entire CI must be worse than the margin. To prove superiority from a non-inferiority trial, the entire CI must exclude the null (HR 1.0).

Reference: JRCPTB; ICH E10; Snapinn et al Trials 2000