Performance and sample size requirements of Bayesian methods for binary outcomes in fixed-dose combination drug studies

J Biopharm Stat. 2009;19(1):120-32. doi: 10.1080/10543400802527916.

Abstract

We develop a Bayesian analysis for the study of fixed-dose combinations of two or more drugs. The approach described here does not require knowledge of the dose-response relationships of the components or large sample approximations. We provide a procedure to estimate sample size in this context. In addition, we explore the performance of the Bayesian procedure in situations where existing methods are known to perform poorly.

MeSH terms

  • Algorithms
  • Bayes Theorem*
  • Binomial Distribution
  • Clinical Trials as Topic / statistics & numerical data*
  • Computer Simulation
  • Drug Synergism
  • Drug Therapy, Combination
  • Humans
  • Monte Carlo Method
  • Pharmaceutical Preparations / administration & dosage
  • Sample Size*

Substances

  • Pharmaceutical Preparations