title: A Bayesian approach for inference from a bridging study with binary outcomes.
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.
authors.affiliation: Global Biometric Sciences, Bristol-Myers Squibb India Pvt. Ltd., Mumbai, India.
authors.forename: Mihir
authors.initials: M
authors.lastname: Gandhi
authors.forename: Bhaswati
authors.initials: B
authors.lastname: Mukherjee
authors.forename: Debjit
authors.initials: D
authors.lastname: Biswas
mesh_terms: D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D003662:Decision Theory; D004358:Drug Therapy; D006801:Humans; D008390:Markov Chains; D009010:Monte Carlo Method; D015337:Multicenter Studies as Topic / Q000379:methods / Q000706:statistics & numerical data*; D010601:Pharmacology, Clinical; D016896:Treatment Outcome