title: Statistical methods for bridging studies.
abstract: In 1998, the International Conference on Harmonization (ICH) published a guidance to facilitate the registration of medicines among ICH regions including the European Union, the United States, and Japan by recommending a framework for evaluating the impact of ethnic factors on a medicine's effect, such as its efficacy and safety at a particular dosage and dose regimen (ICH E5, 1998). The purpose of ICH E5 is not only to evaluate the ethnic factor influence on safety, efficacy, dosage, and dose regimen, but also more importantly to minimize duplication of clinical data and allow extrapolation of foreign clinical data to a new region. In this article, statistical methods for evaluation of bridging studies based on the concepts of consistency (Shih, 2001), reproducibility/generalizability (Shao and Chow, 2002), the weighted Z-tests for the design of bridging studies (Lan et al., 2005), and similarity between the new and original region based in terms of positive treatment effect (Hsiao et al., 2007) are studied. The relative merits and disadvantages of these methods are compared by several examples.
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Chieh
authors.initials: C
authors.lastname: Chiang
authors.forename: Jen-pei
authors.initials: JP
authors.lastname: Liu
authors.forename: Chin-Fu
authors.initials: CF
authors.lastname: Hsiao
mesh_terms: D001499:Bayes Theorem; D003627:Data Interpretation, Statistical; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D005006:Ethnicity; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods / Q000706:statistics & numerical data*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D015203:Reproducibility of Results; D012107:Research Design / Q000706:statistics & numerical data*; D016896:Treatment Outcome
chemical_list: D004364:Pharmaceutical Preparations