Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies  

作　　者：Han Cao Chen Yao Ying Yuan 

机构地区：[1]Department of Biostatistics,Peking University First Hospital,Beijing,China [2]Medical Data Science Center,Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing,China [3]Department of Biostatistics,Peking University First Hospital,No.8,Xishikudajie,Xicheng District,Beijing100034,China [4]Peking University Clinical Research Institute,Beijing 100083,China [5]Hainan Institute of Real World Data,Qionghai 571437,Hainan Province,China [6]Department of Biostatistics,The University of Texas MD Anderson Cancer Center,Houston,USA

出　　处：《Medical Review》2023年第5期408-424,共17页医学评论（英文）

摘　　要：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 ofamedical device in a timelymanner to keep upwith 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.

关 键 词：medical device Bayesian design Bayesian information borrowing 

分 类 号：TH77[机械工程—仪器科学与技术]