Mixtures of multiple testing procedures for gatekeeping applications in clinical trials

Alex Dmitrienko*, Ajit C. Tamhane

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

38 Scopus citations

Abstract

This paper proposes a general framework for constructing gatekeeping procedures for clinical trials with hierarchical objectives. Such problems frequently exhibit complex structures including multiple families of hypotheses and logical restrictions. The proposed framework is based on combining multiple procedures across families. It enables the construction of powerful and flexible gatekeeping procedures that account for general logical restrictions among the hypotheses of interest. A clinical trial in patients with schizophrenia is used to illustrate the approach for parallel gatekeeping, whereas another clinical trial in patients with hypertension is used to illustrate the approach for gatekeeping with general logical restrictions.

Original languageEnglish (US)
Pages (from-to)1473-1488
Number of pages16
JournalStatistics in Medicine
Volume30
Issue number13
DOIs
StatePublished - Jun 15 2011

Keywords

  • Bonferroni procedure
  • Closed procedures
  • Dunnett procedure
  • Error rate function
  • Familywise error rate
  • Gatekeeping procedures
  • Logical restrictions
  • Mixing function
  • Multiple comparisons
  • Separable procedures

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability

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