The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
|
Activity Number:
|
116
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Monday, August 1, 2011 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #301654 |
|
Title:
|
Noninferiority Testing with a Variable Margin
|
|
Author(s):
|
Yonghong Gao*+
|
|
Companies:
|
U.S. Food and Drug Administration/CDRH
|
|
Address:
|
10903 New Hampshire Ave., Silver Spring, MD, 20993,
|
|
Keywords:
|
Non-inferiority ;
variable margin ;
baseline covariates
|
|
Abstract:
|
The determination of non-inferiority margin is important in non-inferiority testing and the value of the margin is usually derived from historical data. If the margin depends on some baseline covariates, and the current active control population differs from the population used in historical trial in subject baseline covariates, namely violating the constancy assumption, then the non-inferiority margin is a variable margin. In this talk we will look at some analysis approaches to conduct non-inferiority testing under the covariate dependent margin.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2011 program
|
2011 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.