Literature DB >> 18161543

Experience with reviewing Bayesian medical device trials.

Gene Pennello1, Laura Thompson.   

Abstract

The purpose of this paper is to present a statistical reviewer's perspective on some technical aspects of reviewing Bayesian medical device trials submitted to the Food and Drug Administration. The discussion reflects the experiences of the authors and should not be misconstrued as official guidance by the FDA. A variety of applications are described, reflecting our experience with therapeutic and diagnostic devices. In addition to Bayesian analysis of trials, Bayesian trial design and Bayesian monitoring are discussed. Analyses were implemented in WinBUGS (http://www.mrc-bsu.cam.ac.uk/bugs/winbugs/contents.shtml), with the code provided.

Mesh：

Year:  2008        PMID： 18161543     DOI： 10.1080/10543400701668274

Source DB:  PubMed          Journal:  J Biopharm Stat        ISSN： 1054-3406            Impact factor:   1.051


  16 in total

1.  Detecting and accounting for violations of the constancy assumption in non-inferiority clinical trials.

Authors:  Joseph S Koopmeiners; Brian P Hobbs
Journal:  Stat Methods Med Res       Date:  2016-09-01       Impact factor: 3.021

2.  Bayesian hierarchical modeling based on multisource exchangeability.

Authors:  Alexander M Kaizer; Joseph S Koopmeiners; Brian P Hobbs
Journal:  Biostatistics       Date:  2018-04-01       Impact factor: 5.899

3.  Bayesian clinical trial design using historical data that inform the treatment effect.

Authors:  Matthew A Psioda; Joseph G Ibrahim
Journal:  Biostatistics       Date:  2019-07-01       Impact factor: 5.899

4.  Development and Performance of Dengue Diagnostic Clinical Algorithms in Colombia.

Authors:  Diana María Caicedo-Borrero; José Rafael Tovar; Andrés Méndez; Beatriz Parra; Anilza Bonelo; Jairo Celis; Liliana Villegas; Constanza Collazos; Lyda Osorio
Journal:  Am J Trop Med Hyg       Date:  2020-06       Impact factor: 2.345

5.  Hierarchical commensurate and power prior models for adaptive incorporation of historical information in clinical trials.

Authors:  Brian P Hobbs; Bradley P Carlin; Sumithra J Mandrekar; Daniel J Sargent
Journal:  Biometrics       Date:  2011-03-01       Impact factor: 2.571

6.  Borrowing from Historical Control Data in Cancer Drug Development: A Cautionary Tale and Practical Guidelines.

Authors:  Connor Jo Lewis; Somnath Sarkar; Jiawen Zhu; Bradley P Carlin
Journal:  Stat Biopharm Res       Date:  2019-04-22       Impact factor: 1.452

Review 7.  Use of historical control data for assessing treatment effects in clinical trials.

Authors:  Kert Viele; Scott Berry; Beat Neuenschwander; Billy Amzal; Fang Chen; Nathan Enas; Brian Hobbs; Joseph G Ibrahim; Nelson Kinnersley; Stacy Lindborg; Sandrine Micallef; Satrajit Roychoudhury; Laura Thompson
Journal:  Pharm Stat       Date:  2013-08-05       Impact factor: 1.894

8.  A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS duration: study rationale and design.

Authors:  William T Abraham; JoAnn Lindenfeld; Vivek Y Reddy; Gerd Hasenfuss; Karl-Heinz Kuck; John Boscardin; Robert Gibbons; Daniel Burkhoff
Journal:  J Card Fail       Date:  2014-10-05       Impact factor: 5.712

9.  Bayesian design of a survival trial with a cured fraction using historical data.

Authors:  Matthew A Psioda; Joseph G Ibrahim
Journal:  Stat Med       Date:  2018-06-25       Impact factor: 2.373

10.  A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program.

Authors:  Dominic J Allocco; Louis A Cannon; Amy Britt; John E Heil; Andrey Nersesov; Scott Wehrenberg; Keith D Dawkins; Dean J Kereiakes
Journal:  Trials       Date:  2010-01-07       Impact factor: 2.279
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