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J Biopharm Stat. 2011 Jul;21(4):748-67. doi: 10.1080/10543406.2011.551334.

A mixture gatekeeping procedure based on the Hommel test for clinical trial applications.

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  • 1Dainippon Sumitomo Pharma Co., Ltd., Suita, Osaka 564-0053, Japan.


When conducting clinical trials with hierarchically ordered objectives, it is essential to use multiplicity adjustment methods that control the familywise error rate in the strong sense while taking into account the logical relations among the null hypotheses. This paper proposes a gatekeeping procedure based on the Hommel (1988) test, which offers power advantages compared to other p value-based tests proposed in the literature. A general description of the procedure is given and details are presented on how it can be applied to complex clinical trial designs. Two clinical trial examples are given to illustrate the methodology developed in the paper.

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