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Non-inferiority Trials — SCE Medical Oncology MCQ

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EasyClinical Trials & StatisticsNon-inferiority TrialsSCE Medical Oncology

An oncology registrar is asked about non-inferiority trial design during a teaching session. A trial concludes that drug B is 'non-inferior' to drug A if the lower bound of the 95% CI for the treatment difference does not cross a pre-specified non-inferiority margin. What is the main purpose of non-inferiority trials in oncology?

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Correct answer: B — To demonstrate the new drug is not unacceptably worse than the standard — typically justified when the new drug offers other advantages (e.g. fewer toxicities, oral administration, lower cost)

Non-inferiority trials are used when a new treatment is not expected to be more efficacious but may offer advantages in safety, convenience, quality of life or cost. The pre-specified non-inferiority margin (Δ) defines the maximum acceptable loss of efficacy. If the lower bound of the CI for the treatment difference does not cross -Δ, non-inferiority is declared. Examples: IDEA (3 vs 6 months CAPOX), PHARE (6 vs 12 months trastuzumab), PERSEPHONE (6 vs 12 months trastuzumab).

Reference: JRCPTB Medical Oncology Curriculum; Snapinn et al Trials 2000; ICH E10