Group sequential tests for bivariate response: Interim analyses of clinical trials with both efficacy and safety endpoints

C. Jennison, B. W. Turnbull

Research output: Contribution to journalArticlepeer-review

Abstract

We describe group sequential tests for a bivariate response. The tests are defined in terms of the two response components jointly, rather than through a single summary statistic. Such methods are appropriate when the two responses concern different aspects of a treatment; for example, one might wish to show that a new treatment is both as effective and as safe as the current standard. We present a formulation of the bivariate testing problem, introduce group sequential tests that satisfy Type I error conditions, and show how to find the sample size guaranteeing a specified power. We describe how properties of group sequential tests for bivariate normal observations can be computed by numerical integration.

Original languageEnglish
Pages (from-to)741-752
Number of pages12
JournalBiometrics
Volume49
Issue number3
DOIs
Publication statusPublished - 1 Sep 1993

ASJC Scopus subject areas

  • Statistics and Probability
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Microbiology(all)
  • Agricultural and Biological Sciences(all)
  • Applied Mathematics

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