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Activity Number: 592
Type: Topic Contributed
Date/Time: Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #311227
Title: A Case Study: Examine Trial
Author(s): Charlie Cao*+ and Hung Lam and Craig Wilson and Anthony Edmonds
Companies: Takeda and Takeda and Takeda and Takeda
Keywords: Group Sequential Design ; adaptive design ; futility ; interim analysis ; superiority assessment
Abstract:

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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