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A note on two approaches of testing bridging evidence to a new region
Xiaoyu Dong1, Yu Guo, Yi Tsong
1Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract:
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. (2005) 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 perform a simulation study to examine the type I error rate and power of the two approaches.
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