scholarly journals Bayesian methods in clinical trials with applications to medical devices

2017 ◽  
Vol 24 (6) ◽  
pp. 561-581 ◽  
Author(s):  
Gregory Campbell
Keyword(s):  
Clinical Trials ◽  
Medical Devices ◽  
Bayesian Methods

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals An Outline for Public Registration of Clinical Trials Evaluating Medical Devices

2006 ◽  
Vol 47 (8) ◽  
pp. 1518-1521 ◽  
Author(s):  
Richard L. Popp ◽  
Beverly H. Lorell ◽  
Gregg W. Stone ◽  
Warren Laskey ◽  
John J. Smith ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Devices

Bayesian survival analysis in clinical trials: What methods are used in practice?

2016 ◽  
Vol 14 (1) ◽  
pp. 78-87 ◽  
Author(s):  
Caroline Brard ◽  
Gwénaël Le Teuff ◽  
Marie-Cécile Le Deley ◽  
Lisa V Hampson
Keyword(s):  
Clinical Trials ◽  
Survival Analysis ◽  
Bayesian Methods ◽  
Regression Models ◽  
Final Analysis ◽  
Bayesian Regression ◽  
Phase Iii ◽  
Informative Priors ◽  
Primary Analysis ◽  
Survival Analyses

Background Bayesian statistics are an appealing alternative to the traditional frequentist approach to designing, analysing, and reporting of clinical trials, especially in rare diseases. Time-to-event endpoints are widely used in many medical fields. There are additional complexities to designing Bayesian survival trials which arise from the need to specify a model for the survival distribution. The objective of this article was to critically review the use and reporting of Bayesian methods in survival trials. Methods A systematic review of clinical trials using Bayesian survival analyses was performed through PubMed and Web of Science databases. This was complemented by a full text search of the online repositories of pre-selected journals. Cost-effectiveness, dose-finding studies, meta-analyses, and methodological papers using clinical trials were excluded. Results In total, 28 articles met the inclusion criteria, 25 were original reports of clinical trials and 3 were re-analyses of a clinical trial. Most trials were in oncology (n = 25), were randomised controlled (n = 21) phase III trials (n = 13), and half considered a rare disease (n = 13). Bayesian approaches were used for monitoring in 14 trials and for the final analysis only in 14 trials. In the latter case, Bayesian survival analyses were used for the primary analysis in four cases, for the secondary analysis in seven cases, and for the trial re-analysis in three cases. Overall, 12 articles reported fitting Bayesian regression models (semi-parametric, n = 3; parametric, n = 9). Prior distributions were often incompletely reported: 20 articles did not define the prior distribution used for the parameter of interest. Over half of the trials used only non-informative priors for monitoring and the final analysis (n = 12) when it was specified. Indeed, no articles fitting Bayesian regression models placed informative priors on the parameter of interest. The prior for the treatment effect was based on historical data in only four trials. Decision rules were pre-defined in eight cases when trials used Bayesian monitoring, and in only one case when trials adopted a Bayesian approach to the final analysis. Conclusion Few trials implemented a Bayesian survival analysis and few incorporated external data into priors. There is scope to improve the quality of reporting of Bayesian methods in survival trials. Extension of the Consolidated Standards of Reporting Trials statement for reporting Bayesian clinical trials is recommended.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review

2017 ◽  
Vol 91 ◽  
pp. 111-120 ◽  
Author(s):  
Anne-France Motte ◽  
Stéphanie Diallo ◽  
Hélène van den Brink ◽  
Constance Châteauvieux ◽  
Carole Serrano ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Devices ◽  
Reporting Guidelines ◽  
Implantable Medical Devices
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