Abstract Details
Activity Number:
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592
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311227
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Title:
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A Case Study: Examine Trial
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Author(s):
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Charlie Cao*+ and Hung Lam and Craig Wilson and Anthony Edmonds
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Companies:
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Takeda and Takeda and Takeda and Takeda
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Keywords:
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Group Sequential Design ;
adaptive design ;
futility ;
interim analysis ;
superiority assessment
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Abstract:
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Cardiovascular ( CV ) outcomes studies have been requested by FDA in diabetes mellitus to rule out excess CV safety risk. In response to this guidance and a corresponding FDA's letter related to CV data,Takeda designed the EXAMINE trial in 2009 and completed in 2013. This study utilized a group sequential design (GSD) to meet pre-marketing and post-marketing requirements with the upper bound of the two-sided 95% confidence interval for hazard ratio < 1.8 and < 1.3, respectively while maintaining an overall one-sided type 1 error rate of 2.5%. This presentation will discuss the modeling and simulation works that were used in various decision making process including interim analyses, futility criterion, superiority assessment utilizing the adaptive design.
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Authors who are presenting talks have a * after their name.
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