Bayesian Design of Noninferiority Clinical Trials with Co-primary Endpoints and Multiple Dose Comparison

Author:

Li Wenqing,Chen Ming-Hui,Tan Huaming,Dey Dipak K.

Publisher

Springer International Publishing

Reference27 articles.

1. Chen M-H, Ibrahim JG, Lam P, Yu A, Zhang Y (2011) Bayesian design of non-inferiority trials for medical devices using historical data. Biometrics 67:1163–1170

2. Chuang-Stein C, Stryszak P, Dmitrienko A, Offen W (2007) Challenge of multiple co-primary endpoints: a new approach. Stat Med 26:1181–1192

3. CPMP (2000) Points to consider on switching between superiority and non-inferiority. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf

4. CHMP (2005) Guideline on the choice of the non-inferiority margin. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf

5. CPMP Working Party on Efficacy of Medicinal Products Note for Guidance III/3630/92-EN (1995) Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. Stat Med 14:1659–1682

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1. Bayesian Design of Superiority Trials: Methods and Applications;Statistics in Biopharmaceutical Research;2022-07-18

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