title: A note on two approaches of testing bridging evidence to a new region.
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.
authors.affiliation: Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Xiaoyu
authors.initials: X
authors.lastname: Dong
authors.forename: Yu
authors.initials: Y
authors.lastname: Guo
authors.forename: Yi
authors.initials: Y
authors.lastname: Tsong
mesh_terms: D000465:Algorithms; D003627:Data Interpretation, Statistical; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D016896:Treatment Outcome