Considerations for Consistency or Inconsistency Assessment in Global Trial Design
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*H.M. James Hung, FDA 

Keywords: random effect, heterogeneity, effect reversal

One of the challenging issues encountered in analysis of a global clinical trial concerns whether there is large heterogeneity in the treatment effect of a test medical product across the regions. This issue has led to a number of consistency or inconsistency criteria considered in the literature or by regulatory guidelines. This presentation is devoted to the potential impacts of consistency or inconsistency assessments on trial planning and statistical inferences under different models.