Issues in Global Simultaneous Development
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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 3rd KH-Symposium 3 Oct. 2002


Japanese specific issues in the international studies
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


Challenges in international studies
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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