Statistical methods for bridging studies
Journal
Journal of Biopharmaceutical Statistics
Journal Volume
22
Journal Issue
5
Pages
903-915
Date Issued
2012
Author(s)
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. ? 2012 Taylor and Francis Group, LLC.
Subjects
Complete clinical data package (CCDP); Consistency; Ethnic factor; Generalizability; Similarity
SDGs
Other Subjects
article; Bayes theorem; clinical study; decision making; dose response; drug efficacy; drug safety; ethnic difference; ethnicity; Europe; human; Japan; practice guideline; priority journal; publication; reproducibility; signal noise ratio; statistical analysis; United States; Bayes Theorem; Data Interpretation, Statistical; Drug Therapy; Ethnic Groups; Guidelines as Topic; Humans; Multicenter Studies as Topic; Pharmaceutical Preparations; Reproducibility of Results; Research Design; Treatment Outcome
Type
journal article