Bayesian Design of Non-inferiority Clinical Trials Via the Bayes Factor

Wenqing Li, Ming-Hui Chen (), Xiaojing Wang and Dipak K. Dey
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Wenqing Li: Ventana Medical Systems, Inc.
Ming-Hui Chen: University of Connecticut
Xiaojing Wang: University of Connecticut
Dipak K. Dey: University of Connecticut

Statistics in Biosciences, 2018, vol. 10, issue 2, No 10, 439-459

Abstract: Abstract We develop a Bayes factor-based approach for the design of non-inferiority clinical trials with a focus on controlling type I error and power. Historical data are incorporated in the Bayesian design via the power prior discussed in Ibrahim and Chen (Stat Sci 15:46–60, 2000). The properties of the proposed method are examined in detail. An efficient simulation-based computational algorithm is developed to calculate the Bayes factor, type I error, and power. The proposed methodology is applied to the design of a non-inferiority medical device clinical trial.

Keywords: Fitting prior; Power prior; Sampling prior; Sample size determination; Type I error (search for similar items in EconPapers)
Date: 2018
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Citations: View citations in EconPapers (1)

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DOI: 10.1007/s12561-017-9200-5

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