Considerations for Consistency or Inconsistency Assessment in Global Trial Design
View Presentation *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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC