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

Thomas Brechenmacher*, Jane Xu, Alex Dmitrienko, Ajit C. Tamhane

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)748-767
Number of pages20
JournalJournal of Biopharmaceutical Statistics
Volume21
Issue number4
DOIs
StatePublished - Jul 2011

Keywords

  • Clinical trials
  • Closed testing
  • Gatekeeping procedure
  • Hierarchical objectives
  • Hommel procedure
  • Multiple testing

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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