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

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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.

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Acknowledgements

The authors would like to thank the Editor, the Guest Editors, and two anonymous referees for their helpful comments. The authors would also like to thank Jim Ranger-Moore, Sr. Director, Biostatistics & Data Management, Ventana Medical Systems, Inc., for reading the manuscript carefully and providing useful comments. These comments have lead to a much improved version of the paper. Dr. M.-H. Chen’s research was partially supported by NIH Grants #GM70335 and #P01CA142538.

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Authors and Affiliations

  1. Ventana Medical Systems, Inc., 1910 East Innovation Park Drive, Tucson, AZ, 85755, USA

    Wenqing Li

  2. Department of Statistics, University of Connecticut, 215 Glenbrook Road, U-4120, Storrs, CT, 06269, USA

    Ming-Hui Chen, Xiaojing Wang & Dipak K. Dey

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  1. Wenqing Li
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  2. Ming-Hui Chen
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  3. Xiaojing Wang
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  4. Dipak K. Dey
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Correspondence to Ming-Hui Chen.

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Li, W., Chen, MH., Wang, X. et al. Bayesian Design of Non-inferiority Clinical Trials Via the Bayes Factor. Stat Biosci 10, 439–459 (2018). https://doi.org/10.1007/s12561-017-9200-5

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  • DOI: https://doi.org/10.1007/s12561-017-9200-5

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