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Issues in Global Simultaneous Development Kihito Takahashi MD The 3 rd KH-Symposium 3 Oct. 2002

Issues in Global Simultaneous Development Kihito Takahashi MD The 3 rd KH-Symposium 3 Oct. 2002. Japanese-specific Issues in the International Studies. How many patients is enough from Japan? Ethnicity sub-analysis necessary ? The study is powered based on the total number of subjects

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Issues in Global Simultaneous Development Kihito Takahashi MD The 3 rd KH-Symposium 3 Oct. 2002

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  1. Issues in Global Simultaneous Development Kihito Takahashi MD The 3rd KH-Symposium 3 Oct. 2002

  2. Japanese-specific Issues in the International Studies • How many patients is enough from Japan? • Ethnicity sub-analysis necessary ? • The study is powered based on the total number of subjects • Meaning of strictly pre-defined similarity criteria between Japanese and others in race subanalysis

  3. Challenges in International Studies • Data management standards • IT system integration • Data quality • Language • Regulatory practice and requirements • Global study management • Clinical study report development

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