A Bayesian approach for inference from a bridging study with binary outcomes

J Biopharm Stat. 2012 Sep;22(5):935-51. doi: 10.1080/10543406.2012.698436.

Abstract

To address concerns that ethnic differences in any clinical trial may affect the performance of a treatment, separate clinical trials may be required for different regions. If a drug is approved in one region based on a bigger clinical trial, a bridging study with smaller size may be conducted in a new region to evaluate the similarity of the earlier clinical data to the new population. This article applies a Bayesian strategy to combine a bridging study with reference studies to assess treatment effect similarity for binary endpoints. The methods have been illustrated with a numerical example using Markov-chain Monte Carlo (MCMC) techniques.

Publication types

  • Review

MeSH terms

  • Bayes Theorem*
  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / statistics & numerical data
  • Data Interpretation, Statistical*
  • Decision Theory
  • Drug Therapy
  • Humans
  • Markov Chains
  • Monte Carlo Method
  • Multicenter Studies as Topic / methods
  • Multicenter Studies as Topic / statistics & numerical data*
  • Pharmacology, Clinical
  • Treatment Outcome