Publication: A mixed approach for proving non-inferiority in clinical trials with binary endpoints
A mixed approach for proving non-inferiority in clinical trials with binary endpoints
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Rousson, V., & Seifert, B. (2008). A mixed approach for proving non-inferiority in clinical trials with binary endpoints. Biometrical Journal, 50(2), 190–204. https://doi.org/10.1002/bimj.200710410
Abstract
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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
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- Rousson, V
- Seifert, Burkhardt
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Rousson, V., & Seifert, B. (2008). A mixed approach for proving non-inferiority in clinical trials with binary endpoints. Biometrical Journal, 50(2), 190–204. https://doi.org/10.1002/bimj.200710410
