• Fitting prior;
  • Hierarchical model;
  • Power prior;
  • Sampling prior;
  • Simulation

Summary We develop a new Bayesian approach of sample size determination (SSD) for the design of noninferiority clinical trials. We extend the fitting and sampling priors of Wang and Gelfand (2002, Statistical Science17, 193–208) 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, Statistical Science15, 46–60). 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 noninferiority medical device clinical trial with historical data from previous trials.