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

Medical Review 2023年第5期3卷 408-424页

作者： Han Cao Chen Yao Ying Yuan Department of Biostatistics Peking University First HospitalBeijingChina Medical Data Science Center Beijing Tsinghua Changgung HospitalSchool of Clinical MedicineTsinghua UniversityBeijingChina Department of Biostatistics Peking University First HospitalNo.8XishikudajieXicheng DistrictBeijing100034China Peking University Clinical Research Institute Beijing 100083China Hainan Institute of Real World Data Qionghai 571437Hainan ProvinceChina Department of Biostatistics The University of Texas MD Anderson Cancer CenterHoustonUSA

Medical device technology develops rapidly,and the life cycle of a medical device is much shorter than *** is necessary to evaluate the safety and effectiveness ofamedical device in a timelymanner to keep upwith technology *** methods provides an efficient approach to addressing this *** 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 *** 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 *** 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

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