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:
|
531
|
Type:
|
Roundtables
|
Date/Time:
|
Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #302576 |
Title:
|
Current Issues in the Design and Analysis of Noninferiority Trials
|
Author(s):
|
Gang Li*+
|
Companies:
|
Johnson & Johnson Pharmaceutical R&D, LLC
|
Address:
|
920 US Highway 202 S, Raritan, NJ, 08869,
|
Keywords:
|
Inferiority index ;
non-inferiority margin ;
bioequivalence ;
biosimilarity
|
Abstract:
|
Despite the release in 2010 of an FDA draft guidance on non-inferiority trials, controversies still exist. Perhaps the most difficult issue in designing non-inferiority trials has been specification of the non-inferiority margin, particularly when there's insufficient historical placebo-controlled information. The subjectivity of the currently used approaches for margin specification is also a source of the controversies. This session is to provide a platform for further dialogue on non-inferiority trials, including a new approach for margin specification.
|
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.