Bayesian Design of Non-Inferiority Clinical Trials via the Bayes Factor.

TitleBayesian Design of Non-Inferiority Clinical Trials via the Bayes Factor.
Publication TypeJournal Article
Year of Publication2018
AuthorsLi, Wenqing, Ming-Hui Chen, Xiaojing Wangy, and Dipak K. Dey
JournalStat Biosci
Volume10
Issue2
Pagination439-459
Date Published2018 Aug
ISSN1867-1764
Abstract

We developed a Bayes factor based approach for the design of non-inferiority clinical trials with a focus on controlling type I error and power. Historical data are incorporated in the Bayesian design via the power prior discussed in Ibrahim and Chen (2000). The properties of the proposed method are examined in detail. An efficient simulation-based computational algorithm is developed to calculate the Bayes factor, type I error and power. The proposed methodology is applied to the design of a non-inferiority medical device clinical trial.

DOI10.1007/s12561-017-9200-5
Alternate JournalStat Biosci
Original PublicationBayesian design of non-inferiority clinical trials via the Bayes factor.
PubMed ID30344778
PubMed Central IDPMC6191065
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States
R01 GM070335 / GM / NIGMS NIH HHS / United States