Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data

We develop a new Bayesian approach of sample size determination (SSD) for the design of non-inferiority clinical trials. We extend the fitting and sampling priors of Wang and Gelfand (2002) to Bayesian SSD with a focus on controlling the type I error and power. Historical data are incorporated via a hierarchical modeling approach as well as the power prior approach of Ibrahim and Chen (2000). Various properties of the proposed Bayesian SSD methodology are examined and a simulation-based computational algorithm is developed. The proposed methodology is applied to the design of a non-inferiority medical device clinical trial with historical data from previous trials