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

摘要

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 . 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.