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Activity Number: 500
Type: Contributed
Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #312195 View Presentation
Title: Assessing Subgroup Consistency in Noninferiority Clinical Trials
Author(s): Oliver Lee*+ and Kathy Zhang and Alan Rong
Companies: Amgen and Amgen and Amgen
Keywords: Non-inferiority ; Multi-regional clinical trials ; Consistency
Abstract:

Using multi-regional clinical trials to register new drugs in certain countries requires demonstrating that the regional treatment effect is consistent with the global effect. Most of the literature has focused on addressing this problem for superiority clinical trials, but methods for non-inferiority designs are needed as well. For these studies the objective is to show that the experimental drug is non-inferior to an existing standard treatment. The non-inferiority design adds complexity to the setting beginning with the definition of consistency. We utilize the fixed margin non-inferiority method and propose possible definitions for treatment consistency. We develop methods to test for regional treatment consistency based on the proposed definitions and extend our methods to the design of future non-inferiority multi-regional clinical trials with a predefined country of interest. Our work is motivated by oncology clinical trials with time-to-event end points.


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