The experience in the FDA's Center for Devices and Radiological Health with Bayesian strategies

1. Berry D . Using a Bayesian approach in medical device development. Technical Report 97–21. Duke University Institute of Statistics and Decision Sciences: Durham, North Carolina, 1997. Retrieved July 2005 from http://ftp.stat.duke.edu/Workingpapers/97–21.ps

2. Kadane JB . Prime time for Bayes. Controlled Clinical Trials 1995; 16: 313–318.

3. Gelman A , Carlin JB , Stern HS , Rubin DB . Bayesian data analysis, second edition. New York: Chapman & Hall, 2004.

4. Gilks WR , Richardson S , Spiegelhalter DJ . Markov chain Monte Carlo in practice. New York: Chapman & Hall, 1996.

5. Spiegelhalter DJ , Thomas A , Best NG , Gilks WR . BUGS: Bayesian inference using Gibbs sampling, version 0.6. MRC Biostatistics Unit: Cambridge, 2003. Retrieved October 2004, from www.mrc-bsu.cam.ac.uk/bugs/documentation/Download/addman06.pdf

6. Irony TZ , Pennello GA . Choosing an appropriate prior for Bayesian medical device trials in the regulatory setting. In American Statistical Association 2001 Proceedings of the Biopharmaceutical Section, Joint Statistical Meetings, Atlanta, Georgia, August 3–7, 2001. American Statistical Association: Alexandria, Virginia, 2001, Vol. M, 85.

7. Spiegelhalter DJ , Abrams KR , Myles JP . Bayesian approaches to clinical trials and health-care evaluation. New York: Wiley, 2004: 344-344.

8. Malec D . A closer look at combining data among a small number of binomial experiments. Stat Med 2001; 20: 1811–1824.

9. Pennello GA . Comparing monitoring devices when a gold standard is unavailable: application to pulse oximeters. In American Statistical Association 2003 Proceedings of the Biopharmaceutical Section, Joint Statistical Meetings. American Statistical Association: Alexandria, Virginia, 2003: 3256–3263.

10. Gould AL . Using prior findings to augment active-controlled trials and trials with small placebo groups. Drug Info J 1991; 25: 369–380.

11. Simon R . Bayesian design and analysis of active control clinical trials. Biometrics 1999; 55: 484–487.

12. Kadane JB . Bayesian methods and ethics in a clinical trial design. New York: John Wiley and Sons, 1996.

13. Lewis RJ . Bayesian hypothesis testing: interim analysis of a clinical trial evaluating phenytoin for the prophylaxis of early post-traumatic seizures in children. In Berry DA & Stangl DK eds. Bayesian biostatistics. New York: Marcel Dekker, 1996: 279–296.

14. DuMouchel W . Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Amer Statistician 1999; 53: 177–202.

15. Dixon DO , Simon R . Bayesian subset analysis in a colorectal cancer clinical trial. Stat Med 1992; 11: 13–22.

16. Ibrahim JG , Chen M-H , Sinha D . Bayesian survival analysis. New York: Springer, 2001: 23–25.