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Journal of Clinical Epidemiology
Volume 64, Issue 3
, Pages 270-279
, March 2011
Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices
References
- . The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care. 1998;4(Spec No(4)):SP188–199
- Rapport du Sénat, Le fonctionnement des comités consultatifs de protection des personnes dans la recherche biomédicale, Paris. Available at http://www.senat.fr/rap/r00-267/r00-267.html2001;
- Agence Française de Sécurité Sanitaire des Produits de Santé, Rapport annuel. Available at http://www.afssaps.fr/var/afssaps_site/storage/original/application/11a395b6c25d1a12039513abea3f2eec.pdf2007;
- . Statistics in the world of medical devices: the contrast with pharmaceuticals. J Biopharm Stat. 2008;18:4–19
- . A device is not a drug. J Card Fail. 2003;9:155–157
- HAS opinions. Available at http://www.has-sante.fr/portail/jcms/c_5267/actes-produits-de-sante?cid=c_5267
- . The role of surrogate outcome measures in evaluating medical devices. Surgery. 2000;128:379–385
- . Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324:1448–1451
- . Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation. Surgery. 2003;133:608–613
- . Practical Bayesian design and analysis for drug and device clinical trials. J Biopharm Stat. 2008;18:54–80
- . Experience with reviewing Bayesian medical device trials. J Biopharm Stat. 2008;18:81–115
- . Applying Bayesian ideas in drug development and clinical trials. Stat Med. 1993;12:1501–1511discussion 13–17
- . Methods in health service research. An introduction to Bayesian methods in health technology assessment. BMJ. 1999;319:508–512
- . A case for Bayesianism in clinical trials. Stat Med. 1993;12:1377–1393discussion 95–404
- . Introduction to Bayesian methods III: use and interpretation of Bayesian tools in design and analysis. Clin Trials. 2005;2:295–300discussion 1–4, 64–78
- . Bayesian clinical trials. Nat Rev Drug Discov. 2006;5:27–36
- . Bayesian predictive inference for units with small sample sizes. The case of binary random variables. Med Care. 1993;31(5 Suppl):YS66–YS70
- . Bayesian population estimation for small sample capture-recapture data using noninformative priors. J Stat Plan Inference. 2007;137:1099–1118
- . An introduction to the Bayesian analysis of clinical trials. Ann Emerg Med. 1993;22:1328–1336
- . The experience in the FDA's Center for Devices and Radiological Health with Bayesian strategies. Clin Trials. 2005;2:359–363discussion 64–78
- U.S. Food and Drug Administration. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. Center for Devices and Radiological Health, Division of Biostatistics, Office of Surveillance and Biometrics. Rockville,MD. February 5, 2010. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071121.pdf
- . Bayesian methods in health technology assessment: a review. Health Technol Assess. 2000;4(38):1–130
- . Bayesian standards in science (BaSiS). Available at http://lib.stat.cmu.edu/bayesworkshop/2001/BaSis.html2001;
- . Seven items were identified for inclusion when reporting a Bayesian analysis of a clinical study. J Clin Epidemiol. 2005;58:261–268
- . Bayesian predictions of final outcomes: regulatory approval of a spinal implant. Clin Trials. 2005;2:325–333discussion 34–39, 64–78
- . A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004;364:583–591
- . Evidence for use of coronary stents. A hierarchical Bayesian meta-analysis. Ann Intern Med. 2003;138:777–786
- . A Bayesian meta-analysis comparing AngioJet thrombectomy to percutaneous coronary intervention alone in acute myocardial infarction. J Interv Cardiol. 2008;21:459–482
- . Combined resynchronisation and implantable defibrillator therapy in left ventricular dysfunction: Bayesian network meta-analysis of randomised controlled trials. BMJ. 2007;335:925
- Suprarenal endograft fixation and medium-term renal function: systematic review and meta-analysis. J Vasc Surg. 2008;47:1364–1370
- . Summary of safety and effectiveness data (P000028). AFFINITY Anterior Cervical Cage System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000028b.pdfJune 13, 2002;
- . Summary of safety and effectiveness data (P000053). AMS Sphincter 800 Urinary Prosthesis. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000053b.pdfJune 14, 2001;
- . Summary of safety and effectiveness data (P980048). BAK/Cervical Interbody Fusion System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P980048b.pdfApril 20, 2001;
- . Summary of safety and effectiveness (P080007). Bard E-LUMINEXX Vascular Stent. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080007b.pdfDecember 4, 2008;
- . Summary of safety and effectiveness data (P060023). BRYAN Cervical Disc. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060023b.pdfJuly 17, 2009;
- . Summary of safety and effectiveness data (P000036). DERMAGRAFT. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000036b.pdfSeptember 28, 2001;
- . Summary of safety and effectiveness data (P040021). Epic Valve. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040021b.pdfNovember 15, 2007;
- . Summary of safety and effectiveness data (P020014). Essure System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014b.pdfNovember 4, 2002;
- . Summary of safety and effectiveness data (P000058). InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdfJuly 2, 2002;
- . Summary of safety and effectiveness data (P970015). Intervertebral body fusion device, INTER FIX Threated Fusion Device. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P970015b.pdfMay 14, 1999;
- . Summary of safety and effectiveness data (P060018). PRESTIGE Cervical Disc System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060018b.pdfJuly 16, 2007;
- . Summary of safety and effectiveness data (P040021). SJM Biocor Valve. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040021b.pdfAugust 5, 2005;
- . Borrowing strength from external trials in a meta-analysis. Stat Med. 1996;15:2733–2749
- . Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening. Stat Med. 2000;19:3359–3376
- . Bayesian methods in meta-analysis and evidence synthesis. Stat Methods Med Res. 2001;10:277–303
- . Systematic reviews of trials and other studies. Health Technol Assess. 1998;2(19):1–276
- . Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials. J Clin Epidemiol. 2009;62:13–21e5
- . Comments on Bayesian and frequentist analysis and interpretation of clinical trials. Control Clin Trials. 1996;17:423–434
- . The CHART trials: Bayesian design and monitoring in practice. CHART Steering Committee. Stat Med. 1994;13:1297–1312
- . Ethics of clinical trials from a Bayesian and decision analytic perspective: whose equipoise is it anyway?. BMJ. 2003;326:980–981
- . Equipoise and the ethics of randomization. J R Soc Med. 1995;88:552–559
- . Markov Chain Monte Carlo convergence diagnostics: a comparative review. J Am Stat Assoc. 1996;91:883–904
- . Prior specification in Bayesian statistics: three cautionary tales. J Theor Biol. 2006;242:90–100
PII: S0895-4356(10)00185-X
doi: 10.1016/j.jclinepi.2010.03.018
© 2011 Elsevier Inc. All rights reserved.
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Journal of Clinical Epidemiology
Volume 64, Issue 3
, Pages 270-279
, March 2011
