Statistical methods for bridging studies.

Published

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Chiang, C; Liu, J-P; Hsiao, C-F

Published Date

  • September 2012

Published In

Volume / Issue

  • 22 / 5

Start / End Page

  • 903 - 915

PubMed ID

  • 22946939

Pubmed Central ID

  • 22946939

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543406.2012.701578

Language

  • eng

Conference Location

  • England