Bayesian statistics in medical devices: Innovation sparked by the FDA

Journal of Biopharmaceutical Statistics

Volumn 21, Issue 5, 2011, Pages 871-887

  Campbell, Gregory ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Adaptive designs; Bayesian hierarchical models; Implants; Noninferiority; Software

Indexed keywords

ARTICLE; BAYESIAN LEARNING; DEVICE; FOOD AND DRUG ADMINISTRATION; MEDICAL LITERATURE; METHODOLOGY; PRIORITY JOURNAL; STATISTICS; UNITED STATES;

BAYES THEOREM; CLINICAL TRIALS AS TOPIC; COMPUTERS; DECISION SUPPORT TECHNIQUES; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; HUMANS; MODELS, STATISTICAL; PRODUCT SURVEILLANCE, POSTMARKETING; RESEARCH DESIGN; SOFTWARE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80051730237     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2011.589638     Document Type: Article

References (38)

1. Ashby, D. (2006). Bayesian statistics in medicine: A 25 year review. Statistics in Medicine 25:3589-3631. (Pubitemid 44613898)
2. Barker, A. D., Sigman, C. C., Kelloff, G. J., Hylton, N. M., Berry, D. A., Esserman, L. J. (2009). I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clinical Pharmacology Therapeutics 86(1):97-100.
3. Berry, S. M., Carlin, B. P., Lee, J. J., Muller, P. (2010). Bayesian Adaptive Methods for Clinical Trials. Boca Raton, FL: CRC Press.
4. Biswas, S., Liu, D. D., Lee, J. J., Berry, D. A. (2009). Bayesian clinical trials at the University of Texas M. D. Anderson Cancer Center. Clinical Trials 6:205-216.
5. Bonangelino, P., Irony, T., Liang, S., Li, X., Mukhi, V., Ruan, S., Xu, Y., Yang, Y., Wang, C. G. (2011). Bayesian approaches in medical device clinical trials: A discussion with examples in the regulatory setting. Journal of Biopharmaceutical Statistics 21:(this issue).
6. Campbell, G. (2005). The experience in the Center for Devices and Radiological Health with Bayesian strategies. Clinical Trials 2:359-363. (Pubitemid 41306279)
7. Campbell, G. (2008). Statistics in the world of medical devices: The contrast with pharmaceuticals. Journal of Biopharmaceutical Statistics 18:4-19.
8. Campbell, G., Pennello, G., Yue, L. Q. (2011). Missing data in the regulation of medical devices. Journal of Biopharmaceutical Statistics 21:180-195.
9. Castro, M., Rubin, A. S., Laviolette, M., Fiterman, J., Lima, M. D. A., Shah, P. L., Fiss, E., Olivenstein, R., Thomson, N. C., Niven, R. M., Pavord, I. D., Simoff, M., Duhamel, D. R., McEvoy, C., Barbers, R., ten Hacken, N. H. T., Wechsler, M. E., Holmes, M., Phillips, M. J., Erzurum, S., Lunn, W., Israel, E., Jarjour, N., Kraft, M., Shargill, N. S., Quiring, J., Berry, S., Cox, G. (2010). Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: A multicenter, randomized, double-blind, sham-controlled clinical trial. American Journal of Respiratory Critical Care Medicine 181:116-124.
10. Chen, M.-H., Ibrahim, J. G., Lam, P., Yu, A., Zhang, Y. (2011). Bayesian design of noninferiority trials for medical devices using historical data. Biometrics doi: 10.1111/j.1541-0420.2011.01561.x.
11. DeMets, D. L. (2000). The role of surrogate outcome measures in evaluating medical devices. Surgery 128:379-385.
12. Dendukuri, N., Joseph, L. (2001). Bayesian approaches to modeling the conditional dependence between multiple diagnostic tests. Biometrics 57:158-167. (Pubitemid 32200150)
13. Dendukuri, N., Belisle, P., Joseph, L. (2009). Bayesian sample size for diagnostic test studies in the absence of a gold standard: Comparing identifiable with non-identifiable models. Biometrics 60:388-3987.
14. Dendukuri, N., Rahme, E., Belisle, P., Joseph, L. (2004). Bayesian sample size determination for prevalence and diagnostic test studies in the absence of a gold standard test. Biometrics 60:388-397. (Pubitemid 38780198)
15. DuMouchel, W. (1999). Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. American Statistician 53(3):177-202.
16. Food and Drug Administration (2010). Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (released February 5, 2010). http://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm071072.htm (accessed April 29, 2011).
17. Hobbs, B. P., Carlin, B. P. (2008). Practical Bayesian design and analysis for drug and device clinical trials. Journal of Biopharmaceutical Statistics 18:54-80.
18. Hobbs, B. P., Carlin, B. P., Mandrekar, S. J., Sargent, D. J. (2011). Hierarchical commensurate and power prior models for adaptive incorporation of historical information in clinical trials. Biometrics doi: 10.1111/j.1541-0420. 2011.01564.x.
19. Hobbs, B. P., Sargent, D. J., Carlin, B. P. (2004). Commensurate priors for incorporating historical information in clinical trials using general and generalized linear models. Bayesian Analysis 1:1-22.
20. Holmes, D. R., Reddy, V. Y., Turi, Z. G., Doshi, S. K., Sievert, H., Buchbinder, M., Mullin, C. M., Sick, P. (2009). Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: A randomised non-inferiority trial. Lancet 374:534-542.
21. Hughes, M. D. (1993). Reporting Bayesian analyses of clinical trials. Statistics in Medicine 12:1651-1663. (Pubitemid 23272632)
22. Ibrahim, J. G., Chen, M.-H. (2000). Power prior distributions for regression models. Statistical Science 15:46-60.
23. Joseph, L., Gyorkos, T. W., Coupal, L. (1995). Bayesian estimation of disease prevalence and the parameters of diagnostic test in the absence of a gold standard. American Journal of Epidemiology 141:263-272.
24. Kadane, J. B. (1995). Prime time for Bayes. Controlled Clinical Trials 16(5):313-318.
25. Lang, T. A., Secic, M. (2006). How to Report Statistics in Medicine. 2nd ed. American Philadelphia, PA: College of Physicians.
26. Lipscomb, B., Ma, G., Berry, D. A. (2005). Bayesian predictions of final outcomes: Regulatory approval of a spinal implant. Clinical Trials 2:325-333. (Pubitemid 41306275)
27. Lunn, D. J., Thomas, A., Best, N., Spiegelhalter, D. (2000) WinBUGS-A Bayesian modelling framework: Concepts, structure, and extensibility. Statistics and Computing 10:325-337.
28. National Research Council. (2010). The Prevention and Treatment of Missing Data in Clinical Trials. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: National Academies Press.
29. OMalley, A. J., Normand, S. T., Kuntz, R. E. (2003). Application of models for multivariate mixed outcomes to medical device trials: Coronary artery stenting. Statistics in Medicine 22:313-326.
30. Pennello, G. A. (2011). Bayesian analysis of diagnostic test accuracy when disease state is unverified for some subjects. Journal of Biopharmaceutical Statistics 21:(this issue).
31. Pennello, G., Thompson, L. (2008). Experience with reviewing Bayesian medical device trials. Journal of Biopharmaceutical Statistics 18:81-115.
32. Pibouleau, L., Chevret, S. (2010). Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices. Journal of Clinical Epidemiology 64(3):270-279.
33. Spiegelhalter, D. J., Abrams, K. R., Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Chichester, England: John Wiley and Sons, Ltd.
34. Spiegelhalter, D. J., Myles, J. P., Jones, D. R., Abrams, K. R. (2000). Bayesian methods in health technology assessment: A review. Health Technology Assessment 4(38):1-130.
35. Stone, G. W., Martin, J. L., de Boer, M.-J., Margheri, M., Bramucci, E., Blankenship, J. C., Metzer, D. C., Gibbons, R. J., Lindsay, B. S., Weiner, B. H., Lansky, A. J., Krucoff, M. W., Fahy, M., Boscardin, W. J., for the AMIHOT-II Trial Investigators. (2009). Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circulation Cardiovascular Interventions 2:366-375.
36. Sung, L., Hayden, J., Greenberg, M. L., Koren, G., Feldman, B. M., Tomlinson, G. A. (2005). Seven items were identified for inclusion when reporting a Bayesian analysis of a clinical study. Journal of Clinical Epidemiology 58:261-268. (Pubitemid 40249468)
37. Weeden, S., Parmar, M., Freedman, L. S. (2004). Bayesian reporting of clinical trials. In: Geller, N., ed. Advances in Clinical Trial Biostatistics. New York: Marcel Dekker, pp. 161-188.
38. Wilber, D. J., Pappone, C., Neuzil, P., De Paola, A., Marchlinski, F., Natale, A., Maele, L., Daoud, E. G., Calkins, H., Hall, B., Reddy, V., Augello, G., Reynolds, M. R., Vinekar, C., Liu, C. Y., Berry, S. M., Berry, D. A., for the ThermoCool AF Trial Investigators. (2010). Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: A randomized controlled trial. Journal of the American Medical Association 303:333-340.