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A mixed approach for proving non-inferiority in clinical trials with binary endpoints.

Rousson V, Seifert B

Statistical Unit, Institute for Social and Preventive Medicine, University of Lausanne, Rue du Bugnon 17, 1005 Lausanne, Switzerland. Valentin.Rousson@chuv.ch

When a new treatment is compared to an established one in a randomized clinical trial, it is standard practice to statistically test for non-inferiority rather than for superiority. When the endpoint is binary, one usually compares two treatments using either an odds-ratio or a difference of proportions. In this paper, we propose a mixed approach which uses both concepts. One first defines the non-inferiority margin using an odds-ratio and one ultimately proves non-inferiority statistically using a difference of proportions. The mixed approach is shown to be more powerful than the conventional odds-ratio approach when the efficacy of the established treatment is known (with good precision) and high (e.g. with more than 56% of success). The gain of power achieved may lead in turn to a substantial reduction in the sample size needed to prove non-inferiority. The mixed approach can be generalized to ordinal endpoints.

Published 3 April 2008 in Biom J, 50(2): 190-204.
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