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Journal of Biopharmaceutical Statistics Volume 22, 2012 - Issue 5: Bridging and Multiregional Clinical Trials
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Original Articles

Design and Evaluation of Multiregional Trials with Heterogeneous Treatment Effect Across Regions

Chi-Tian Chen Division of Biometry, Graduate Institute of Agronomy, College of Bioresource and Agriculture, National Taiwan University, Taipei, Taiwan
,
H. M. James Hung Division of Biometrics I, DB1/OB/OTS/CDER, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
&
Chin-Fu Hsiao Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Miaoli County, Taiwan; Division of Clinical Trial Statistics, Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Miaoli County, TaiwanCorrespondence[email protected]
Pages 1037-1050 | Received 21 Aug 2010, Accepted 12 Feb 2011, Published online: 04 Sep 2012

Citations (12)

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Yijie Zhou, Lu Cui, Bo Yang, Lanju Zhang & Frank Shen. (2017) Regional efficacy assessment in multiregional clinical development. Journal of Biopharmaceutical Statistics 27:4, pages 673-682.
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Articles from other publishers (11)

Sergey E Golovenkin, Jonathan Bac, Alexander Chervov, Evgeny M Mirkes, Yuliya V Orlova, Emmanuel Barillot, Alexander N Gorban & Andrei Zinovyev. (2020) Trajectories, bifurcations, and pseudo-time in large clinical datasets: applications to myocardial infarction and diabetes data. GigaScience 9:11.
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Yu-Yi Hsu, Jyoti Zalkikar & Ram C Tiwari. (2017) Hierarchical Bayes approach for subgroup analysis. Statistical Methods in Medical Research 28:1, pages 275-288.
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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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Chi-Tian Chen, Hsiao-Hui Tsou, Jung-Tzu Liu, Chin-Fu Hsiao, Fei Chen, Gang Li & K. K. G. Lan. 2018. Biopharmaceutical Applied Statistics Symposium. Biopharmaceutical Applied Statistics Symposium 269 286 .
Wong-Shian Huang, Hui-Nien Hung, Toshimitsu Hamasaki & Chin-Fu Hsiao. (2017) Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints. PLOS ONE 12:6, pages e0180405.
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Akihiro Hirakawa & Fumie Kinoshita. (2017) An Analysis of Japanese Patients Enrolled in Multiregional Clinical Trials in Oncology. Therapeutic Innovation & Regulatory Science 51:2, pages 207-211.
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Jung-Tzu Liu, Hsiao-Hui Tsou, K. K. Gordon LanChi-Tian Chen, Yi-Hsuan Lai, Wan-Jung Chang, Chyng-Shyan Tzeng & Chin-Fu Hsiao. (2016) Assessing the consistency of the treatment effect under the discrete random effects model in multiregional clinical trials. Statistics in Medicine 35:14, pages 2301-2314.
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Jung-Tzu Liu, Chi-Tian Chen, K. K. Gordon Lan, Chyng-Shyan Tzeng, Chin-Fu Hsiao & Hsiao-Hui Tsou. 2016. Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics. Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics 127 136 .
Yuh-Jenn Wu, Te-Sheng Tan, Shein-Chung Chow & Chin-Fu Hsiao. 2013. Topics in Applied Statistics. Topics in Applied Statistics 325 334 .
. 2012. Design and Analysis of Bridging Studies. Design and Analysis of Bridging Studies 238 253 .

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