Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives

Alex Dmitrienko*, Brian L. Wiens, Ajit C. Tamhane, Xin Wang

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

71 Scopus citations

Abstract

This paper discusses a new class of multiple testing procedures, tree-structured gatekeeping procedures, with clinical trial applications. These procedures arise in clinical trials with hierarchically ordered multiple objectives, for example, in the context of multiple dose-control tests with logical restrictions or analysis of multiple endpoints. The proposed approach is based on the principle of closed testing and generalizes the serial and parallel gatekeeping approaches developed by Westfall and Krishen (J. Statist. Planning Infer. 2001; 99:25-41) and Dmitrienko et al. (Statist. Med. 2003; 22:2387-2400). The proposed testing methodology is illustrated using a clinical trial with multiple endpoints (primary, secondary and tertiary) and multiple objectives (superiority and non-inferiority testing) as well as a dose-finding trial with multiple endpoints.

Original languageEnglish (US)
Pages (from-to)2465-2478
Number of pages14
JournalStatistics in Medicine
Volume26
Issue number12
DOIs
StatePublished - May 30 2007

Keywords

  • Clinical trials
  • Dose-finding
  • Muliple tests
  • Multiple endpoints

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability

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