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

Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials

Xiaoyuan Chen Department of Pharmacology and Biostatistics, Shanghai JiaoTong University School of Medicine, Shanghai, China; Center for Drug Evaluation, China State Food and Drug Administration, Beijing, China
,
Nelson Lu Office of Surveillance and Biometrics, CDRH, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Rajesh Nair Office of Surveillance and Biometrics, CDRH, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Yunling Xu Office of Surveillance and Biometrics, CDRH, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Cailian Kang Center for Drug Evaluation, China State Food and Drug Administration, Beijing, China
,
Qin Huang Center for Drug Evaluation, China State Food and Drug Administration, Beijing, China
,
Ning Li U.S. Food and Drug Administration Alumni Association, Gaithersburg, Maryland, USACorrespondence[email protected]
&
Hongzhuan Chen Department of Pharmacology and Biostatistics, Shanghai JiaoTong University School of Medicine, Shanghai, China
 show all
Pages 1001-1018 | Received 11 Oct 2010, Accepted 21 Dec 2011, Published online: 04 Sep 2012

REFERENCES

  • European Medicines Agency. ( 2009 ). Reflection Paper on the Extrapolation of Results From Clinical Studies Conducted Outside Europe to the EU Population. EMEA. Available at: www.emea.europa.eu/pdfs/human/ewp/69270208en.pdf (accessed May 25, 2012) .
  • Glickman , S. W. , McHutchison , J. G. , Peterson , E. D. , Cairns , C. B. , Harrington , R. A. , Califf , R. M. , Schulman , K. A. ( 2009 ). Ethical and scientific implications of the globalization of clinical research . New England Journal of Medicine 360 : 816 – 823 .
  • Quan , H. , Zhao , PL. , Zhang , J. , Roessner , M. , Aizawa , K. ( 2010 ). Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance . Pharmaceutical Statistics 9 : 100 – 112 .
  • International Conference on Harmonisation. (2006). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q&A for the ICH E5 guideline on ethnic factors in the acceptability of foreign data. Available at: www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E5_R1/Q_As/E5_Q_As_R5.pdf
  • Ko , F. S. , Tsou , H. H. , Liu , J. P. , Hsiao , C. F. (2010). Sample size determination for a specific region in a multiregional trial. Journal of Biopharmaceutical Statistics 20:870–885.
  • Ministry of Health , Labor , and Welfare of Japan. ( 2007 ). Basic Principles on Global Clinical Trials. Tokyo: MHLW .
  • Naito , C. ( 2000 ). Necessity and requirements of bridging studies and their present status in Japan . International Journal of Clinical Pharmacology and Therapeutics 38 : 80 – 86 .
  • Kawai , N. , Chuang-Stein , C. , Komiyama , O. , Il , Y. ( 2008 ). An approach to rationalize partitioning sample size into individual regions in a multiregional trial . Drug Information Journal 42 : 139 – 147 .
  • Shih , W. J. ( 2001 ). Clinical trials for drug registrations in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective . Controlled Clinical Trials 22 : 357 – 366 .

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