Transcript PowerPoint プレゼンテーション

Issues in Global Simultaneous
Development
Kihito Takahashi MD
The 3rd 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
 Meaning of strictly pre-defined similarity criteria
between Japanese and others in race subanalysis
2
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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