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Activity Number: 650
Type: Topic Contributed
Date/Time: Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304630
Title: Weighted Z-Test and Weighted Evidence Approaches of Testing Bridging Evidence Into a New Region
Author(s): Xiaoyu Dong*+ and Yu Guo and Yi Tsong
Companies: MedImmune and University of Maryland and FDA/CDER
Address: Apt E, 9018 Town and Country Blvd, Ellicott City, MD, 21043, United States
Keywords: Bridging Study ; Clinical Trial ; Weighted Z ; Multiregion Clinical Trials ; Type I error rate ; Hypothesis Testing

Bridging studies are performed in a new region for medicines already approved in the original region. In order to borrow the strength of the original trial to establish the treatment effect in the bridging region, Lan et al (2007) proposed to use a weighted z-test approach to combine the test statistics of the same hypothesis for both the original and bridging regions for bridging study. Based on a similar concept, Tsou et al (2012) proposed instead to test a hypothesis of the weighted treatment effects of the original and bridging regions. In this article, we explore the differences of the concept in hypothesis testing and performed a simulation study to examine the type I error rate and power of the two approaches.

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