issues in global simultaneous development kihito takahashi md the 3 rd kh-symposium 3 oct. 2002
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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 - PowerPoint PPT Presentation
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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 su
bjects Meaning of strictly pre-defined similarity criteria betw
een 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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