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Original Articles

Sample Size Determination for a Specific Region in a Multiregional Trial

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Pages 870-885 | Received 24 Jul 2008, Accepted 17 May 2009, Published online: 19 May 2010

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (21)

Junhui Park & Seung-Ho Kang. (2022) Hierarchical Generalized Linear Models for Multiregional Clinical Trials. Statistics in Biopharmaceutical Research 14:3, pages 358-367.
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Yuh-Jenn Wu, Te-Sheng Tan, Shein-Chung Chow & Chin-Fu Hsiao. (2014) Sample Size Estimation of Multiregional Clinical Trials with Heterogeneous Variability Across Regions. Journal of Biopharmaceutical Statistics 24:2, pages 254-271.
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JamesD. Stamey, Fanni Natanegara & JohnW. Seaman$suffix/text()$suffix/text(). (2013) Bayesian Sample Size Determination for a Clinical Trial with Correlated Continuous and Binary Outcomes. Journal of Biopharmaceutical Statistics 23:4, pages 790-803.
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Yi Tsong. (2012) Statistical Considerations on Design and Analysis of Bridging and Multiregional Clinical Trials. Journal of Biopharmaceutical Statistics 22:5, pages 1078-1080.
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Chi-Tian Chen, H.M. James Hung & Chin-Fu Hsiao. (2012) Design and Evaluation of Multiregional Trials with Heterogeneous Treatment Effect Across Regions. Journal of Biopharmaceutical Statistics 22:5, pages 1037-1050.
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Yi Tsong, Wan-Jung Chang, Xiaoyu Dong & Hsiao-Hui Tsou. (2012) Assessment of Regional Treatment Effect in a Multiregional Clinical Trial. Journal of Biopharmaceutical Statistics 22:5, pages 1019-1036.
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Xiaoyuan Chen, Nelson Lu, Rajesh Nair, Yunling Xu, Cailian Kang, Qin Huang, Ning Li & Hongzhuan Chen. (2012) Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials. Journal of Biopharmaceutical Statistics 22:5, pages 1001-1018.
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Nathan W Bean, Joseph G Ibrahim & Matthew A Psioda. (2023) Bayesian multiregional clinical trials using model averaging. Biostatistics 24:2, pages 262-276.
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Sisay W. Adall & Jin Xu. (2021) Bayes shrinkage estimator for consistency assessment of treatment effects in multi‐regional clinical trials. Pharmaceutical Statistics 20:6, pages 1074-1087.
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Si‐Cheng Wu, Jin‐Fang Xu, Xin‐Ji Zhang, Zhi‐Wei Li & Jia He. (2020) Regional consistency and sample size considerations in a multiregional equivalence trial. Pharmaceutical Statistics 19:6, pages 897-908.
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Seung-Ho Kang & Saemina Kim. (2018) Statistical implications of extrapolating the overall result to the target region in multi-regional clinical trials. Communications for Statistical Applications and Methods 25:4, pages 341-354.
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Ian Wadsworth, Lisa V Hampson & Thomas Jaki. (2016) Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods. Statistical Methods in Medical Research 27:2, pages 398-413.
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Yuh-Jenn Wu, Te-Sheng Tan, Shein-Chung Chow & Chin-Fu Hsiao. 2013. Topics in Applied Statistics. Topics in Applied Statistics 325 334 .
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Hsiao-Hui Tsou, H. M. James Hung, Yue-Ming Chen, Wong-Shian Huang, Wan-jung Chang & Chin-Fu Hsiao. (2012) Establishing consistency across all regions in a multi-regional clinical trial. Pharmaceutical Statistics 11:4, pages 295-299.
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Shein-Chung Chow. (2011) Sample size calculations for clinical trials. Wiley Interdisciplinary Reviews: Computational Statistics 3:5, pages 414-427.
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Hsiao‐Hui Tsou, Tuan‐Ying Chien, Jen‐pei Liu & Chin‐Fu Hsiao. (2011) A consistency approach to evaluation of bridging studies and multi‐regional trials. Statistics in Medicine 30:17, pages 2171-2186.
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Shein-Chung Chow. 2011. Controversial Statistical Issues in Clinical Trials. Controversial Statistical Issues in Clinical Trials 553 576 .
Shein-Chung Chow & Chin-Fu Hsiao. (2012) Bridging Diversity. Pharmaceutical Medicine 24:6, pages 349-362.
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Hsiao-Hui Tsou, Shein-Chung Chow, K. K. Gordon Lan, Jen-pei Liu, Mey Wang, Herng-Der Chern, Low-Tone Ho, Chao A. Hsiung & Chin-Fu Hsiao. (2010) Proposals of statistical consideration to evaluation of results for a specific region in multi-regional trials - Asian perspective. Pharmaceutical Statistics 9:3, pages 201-206.
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