Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data
Article first published online: 1 MAR 2011
© 2011, The International Biometric Society
Volume 67, Issue 3, pages 1163–1170, September 2011
How to Cite
Chen, M.-H., Ibrahim, J. G., Lam, P., Yu, A. and Zhang, Y. (2011), Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data. Biometrics, 67: 1163–1170. doi: 10.1111/j.1541-0420.2011.01561.x
- Issue published online: 14 SEP 2011
- Article first published online: 1 MAR 2011
- Received March 2010. Revised November 2010. Accepted November 2010.
- Fitting prior;
- Hierarchical model;
- Power prior;
- Sampling prior;
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 Science 17, 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 Science 15, 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.