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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 #312662
Title: Adaptive Switching from Noninferiority to Superiority in Cardiovascular Outcome Trials
Author(s): Lingyun Liu*+
Companies: Cytel
Keywords: adaptive design ; cardiovascular outcome trials ; non-inferiority ; superiority
Abstract:

Diabetes is associated with an elevated risk of cardiovascular disease, which is the leading cause of morbidity and mortality in this patient population. In 2008, FDA issued the guidance for evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Sponsors are required to demonstrate that the investigational agent is non-inferior to the control group with respect to the risk of the major cardiovascular events. At the time of NDA submission, it is necessary to show that the upper bound of the two-sided 95 percent confidence interval for the estimated risk ratio is less than 1.8. If the upper bound of the two-sided 95 percent confidence interval for the estimated increased risk (i.e., risk ratio) is between 1.3 and 1.8, and the overall risk-benefit analysis supports approval, a postmarketing trial generally will be necessary to definitively show that the upper bound of the two-sided 95 percent confidence interval for the estimated risk ratio is less than 1.3. In this talk, we will present an adaptive design which has the flexibility to increase sample size and also allow testing the superiority of the investigation drug to the control drug if the


Authors who are presenting talks have a * after their name.

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