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Statistical methods for bridging studies.

Publication ,  Journal Article
Chow, S-C; Chiang, C; Liu, J-P; Hsiao, C-F
Published in: J Biopharm Stat
September 2012

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.

Duke Scholars

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

September 2012

Volume

22

Issue

5

Start / End Page

903 / 915

Location

England

Related Subject Headings

  • Treatment Outcome
  • Statistics & Probability
  • Research Design
  • Reproducibility of Results
  • Pharmaceutical Preparations
  • Multicenter Studies as Topic
  • Humans
  • Guidelines as Topic
  • Ethnicity
  • Drug-Related Side Effects and Adverse Reactions
 

Citation

APA
Chicago
ICMJE
MLA
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Chow, S.-C., Chiang, C., Liu, J.-P., & Hsiao, C.-F. (2012). Statistical methods for bridging studies. J Biopharm Stat, 22(5), 903–915. https://doi.org/10.1080/10543406.2012.701578
Chow, Shein-Chung, Chieh Chiang, Jen-pei Liu, and Chin-Fu Hsiao. “Statistical methods for bridging studies.J Biopharm Stat 22, no. 5 (September 2012): 903–15. https://doi.org/10.1080/10543406.2012.701578.
Chow S-C, Chiang C, Liu J-P, Hsiao C-F. Statistical methods for bridging studies. J Biopharm Stat. 2012 Sep;22(5):903–15.
Chow, Shein-Chung, et al. “Statistical methods for bridging studies.J Biopharm Stat, vol. 22, no. 5, Sept. 2012, pp. 903–15. Pubmed, doi:10.1080/10543406.2012.701578.
Chow S-C, Chiang C, Liu J-P, Hsiao C-F. Statistical methods for bridging studies. J Biopharm Stat. 2012 Sep;22(5):903–915.

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

September 2012

Volume

22

Issue

5

Start / End Page

903 / 915

Location

England

Related Subject Headings

  • Treatment Outcome
  • Statistics & Probability
  • Research Design
  • Reproducibility of Results
  • Pharmaceutical Preparations
  • Multicenter Studies as Topic
  • Humans
  • Guidelines as Topic
  • Ethnicity
  • Drug-Related Side Effects and Adverse Reactions