This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 541
Type: Roundtables
Date/Time: Wednesday, August 4, 2010 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309333
Title: Demonstrating Superiority of Test Drug to Putative Placebo in the Two-Arm Noninferiority Trial
Author(s): Abdul J. Sankoh*+
Companies: Vertex Pharmaceuticals
Address: 130 Waverly Street, Cambridge, MA, 02139,
Keywords: Cross-trial inference ; Non-inferiority ; Putative placebo ; Superiority ; Two-arm active-control trial
Abstract:

In a two-arm active-control clinical trial, even the superiority of the experimental drug to the active-control does not guarantee superiority of either drug to placebo. Thus in a non-inferiority two-arm clinical trial, there is a need to demonstrate through cross-trial inference that the experimental drug is superior to putative placebo to minimize the chances of approving new drugs that are no better than placebo. We examine in this discussion the issues with current statistical methods for performing such cross-trial inference.


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 2010 program




2010 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.