Abstract

In clinical trials, it is often desirable to test for superiority conditioned on establishment of noninferiority based on the same primary end-point. According to a guidance document issued by the European regulatory agency Committee for Proprietary Medicinal Products in 2001, no type I error rate adjustment is necessary for switching between superiority and non-inferiority because the family-wise type I error rate is controlled at the same nominal level. However, Ng raised the issues of switching between superiority and noninferiority even though there is no inflation of the family-wise type I error rate and showed that the fake discovery rate could be increased.

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