Bayesian Statistics for Medical Devices: Progress Since 2010.

Abstract

The use of Bayesian statistics to support regulatory evaluation of medical devices began in the late 1990s. We review the literature, focusing on recent developments of Bayesian methods, including hierarchical modeling of studies and subgroups, borrowing strength from prior data, effective sample size, Bayesian adaptive designs, pediatric extrapolation, benefit-risk decision analysis, use of real-world evidence, and diagnostic device evaluation. We illustrate how these developments were utilized