Bayesian Approach for Design and Analysis of Medical Device Trials in the Era of Modern Clinical Studies

Authors

Han Cao
Chen Yao
Ying Yuan

Publication Date

10-1-2023

Journal

MedRev

DOI

10.1515/mr-2023-0026

PMID

38283256

PMCID

PMC10810749

PubMedCentral® Posted Date

10-3-2023

PubMedCentral® Full Text Version

Post-print

Abstract

Medical device technology develops rapidly, and the life cycle of a medical device is much shorter than drugs. It is necessary to evaluate the safety and effectiveness of a medical device in a timely manner to keep up with technology flux. Bayesian methods provides an efficient approach to addressing this challenge. In this article, we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting, including Bayesian adaptive design, Bayesian diagnostic design, Bayesian multiregional design, and Bayesian label expansion study. We illustrate these designs with medical devices approved by the US Food and Drug Administration (FDA). We also review several innovative Bayesian information borrowing methods, and briefly discuss the challenges and future directions of the Bayesian application in medical device trials. Our objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments.

Keywords

Bayesian design, Bayesian information borrowing, medical device

Published Open-Access

yes

Recommended Citation

Han Cao, Chen Yao, and Ying Yuan, "Bayesian Approach for Design and Analysis of Medical Device Trials in the Era of Modern Clinical Studies" (2023). Faculty, Staff and Student Publications. 4097.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/4097