Abstract Details
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.
Back to the full JSM 2014 program
|
2014 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Professional Development program, please contact the Education Department.
The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Copyright © American Statistical Association.