Bayesian monitoring of clinical trials with failure-time endpoints

Research output: Contribution to journalReview articlepeer-review

Abstract

This article presents an aid for monitoring clinical trials with failure-time endpoints based on the Bayesian nonparametric analyses of the data. The posterior distribution is a mixture of Dirichlet processes in the presence of censoring if one assumes a Dirichlet process prior for the survival distribution. Using Gibbs sampling, one can generate random samples from the posterior distribution. With samples from the posterior distributions of treatment-specific survival curves, one can evaluate the current evidence in favor of stopping or continuing the trial based on summary statistics of these survival curves. Because the method is nonparametric, it can easily be used, for example, in situations where hazards cross or are suspected to cross and where relevant clinical decisions might be based on estimating when the integral between the curves might be expected to become positive and in favor of the new but toxic therapy. An example based on an actual trial illustrates the method.

Original languageEnglish (US)
Pages (from-to)239-245
Number of pages7
JournalBiometrics
Volume61
Issue number1
DOIs
StatePublished - Mar 2005
Externally publishedYes

Keywords

  • Clinical trials
  • Dirichlet process
  • Gibbs sampling
  • Survival analysis

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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