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Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data
Author(s) -
Chen MingHui,
Ibrahim Joseph G.,
Lam Peter,
Yu Alan,
Zhang Yuanye
Publication year - 2011
Publication title -
biometrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.298
H-Index - 130
eISSN - 1541-0420
pISSN - 0006-341X
DOI - 10.1111/j.1541-0420.2011.01561.x
Subject(s) - bayesian probability , computer science , sample size determination , prior probability , statistical power , type i and type ii errors , clinical trial , sampling (signal processing) , data mining , statistics , machine learning , artificial intelligence , mathematics , medicine , filter (signal processing) , pathology , computer vision
Summary We develop a new Bayesian approach of sample size determination (SSD) for the design of noninferiority clinical trials. We extend the fitting and sampling priors of Wang and Gelfand (2002, Statistical Science 17 , 193–208) to Bayesian SSD with a focus on controlling the type I error and power. Historical data are incorporated via a hierarchical modeling approach as well as the power prior approach of Ibrahim and Chen (2000, Statistical Science 15 , 46–60). Various properties of the proposed Bayesian SSD methodology are examined and a simulation‐based computational algorithm is developed. The proposed methodology is applied to the design of a noninferiority medical device clinical trial with historical data from previous trials.