Key points are not available for this paper at this time.
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 Hommel , G. ( 1988 ). A stagewise rejective multiple test procedure based on a modified Bonferroni test . Biometrika 75 : 383 – 386 .Crossref, Web of Science ® , Google Scholar) 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.
Brechenmacher et al. (Fri,) studied this question.