Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints

Author:

Huang Wong-Shian,Hung Hui-Nien,Hamasaki Toshimitsu,Hsiao Chin-Fu

Funder

Ministry of Science and Technology, Taiwan

Publisher

Public Library of Science (PLoS)

Subject

Multidisciplinary

Reference24 articles.

1. International Conference on Harmonization. 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. 2006. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E5_R1/Q_As/E5_Q_As__R5_.pdf. Accessed on May 3, 2017.

2. International Conference on Harmonization. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH E17 Guideline on General principle on planning/designing Multi-Regional Clinical Trials. 2016. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17_Step2.pdf. Accessed on May 3, 2017.

3. Ministry of Health, Labour and Welfare of Japan. Basic Principles on Global Clinical Trials. 2007. http://www.pmda.go.jp/files/000153265.pdf. Accessed on May 3, 2017.

4. Sample size considerations for Japanese patients in a multi‐regional trial based on MHLW guidance;H Quan;Pharmaceutical Statistics,2010

5. An approach to rationalize partitioning sample size into individual regions in a multiregional trial;N Kawai;Drug Information Journal,2008

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