Brechenmacher Xu Dmitrienko Tamhane 2011

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Brechenmacher, T., Xu, J., Dmitrienko, A., Tamhane, A.C. (2011). A mixture gatekeeping procedure based on the Hommel test for clinical trial applications. Journal of Biopharmaceutical Statistics. 21, 748-767.


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 gatekeeping procedures 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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Software implementation

Computation of multiplicity-adjusted p-values as well as power and Type I error rate calculations for general tree-structured gatekeeping procedures, including the procedure introduced in this paper, can be performed using the TreeGate macro written by Thomas Brechenmacher.

Review papers and chapters

For more information on gatekeeping procedures in clinical trials, see

Other papers

For information on other publications on gatekeeping procedures in clinical trials, see Gatekeeping Papers.