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

Author

Listed:
  • Wenqing Li

    (Ventana Medical Systems, Inc.)

  • Ming-Hui Chen

    (University of Connecticut)

  • Xiaojing Wang

    (University of Connecticut)

  • Dipak K. Dey

    (University of Connecticut)

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.

Suggested Citation

  • Wenqing Li & Ming-Hui Chen & Xiaojing Wang & Dipak K. Dey, 2018. "Bayesian Design of Non-inferiority Clinical Trials Via the Bayes Factor," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 10(2), pages 439-459, August.
    • Handle: RePEc:spr:stabio:v:10:y:2018:i:2:d:10.1007_s12561-017-9200-5
    DOI: 10.1007/s12561-017-9200-5
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    References listed on IDEAS

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    1. Irene Klugkist & Bernet Kato & Herbert Hoijtink, 2005. "Bayesian model selection using encompassing priors," Statistica Neerlandica, Netherlands Society for Statistics and Operations Research, vol. 59(1), pages 57-69, February.
    2. Ming-Hui Chen & Joseph G. Ibrahim & Peter Lam & Alan Yu & Yuanye Zhang, 2011. "Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data," Biometrics, The International Biometric Society, vol. 67(3), pages 1163-1170, September.
    3. M'Lan, Cyr Emile & Joseph, Lawrence & Wolfson, David B., 2006. "Bayesian Sample Size Determination for Case-Control Studies," Journal of the American Statistical Association, American Statistical Association, vol. 101, pages 760-772, June.
    4. Joseph G. Ibrahim & Ming-Hui Chen & H. Amy Xia & Thomas Liu, 2012. "Bayesian Meta-Experimental Design: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," Biometrics, The International Biometric Society, vol. 68(2), pages 578-586, June.
    5. Fulvio De Santis, 2007. "Using historical data for Bayesian sample size determination," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 170(1), pages 95-113, January.
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