New Perspective on the Determination of the Number of Japanese Patients in Multiregional Clinical Trials

Seung-Ho, Kang and Ji-Hun Bae
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Seung-Ho: Department of Applied Statistics, Yonsei University, Korea
Kang: Department of Applied Statistics, Yonsei University, Korea
Ji-Hun Bae: Department of Applied Statistics, Yonsei University, Korea

Biostatistics and Biometrics Open Access Journal, 2018, vol. 5, issue 3, 77-83

Abstract: Through Method 1, the Japanese government wants to acquire a sufficient number of Japanese subjects to determine whether the effect of the test treatment is consistent between Japanese and non-Japanese. However, the Japanese government did not provide clear parameter-based criteria regarding the consistency of the effect of the test treatment between Japanese and non-Japanese. Thus, the goal of the evaluation by Method 1 remains unclear. Currently, it is impossible to interpret Method 1 within a traditional statistical framework. Thus, the purpose of this paper is to propose a new perspective on Method 1 within a traditional statistical framework.

Keywords: Biometrics Open Access Journal; Biostatistics and Biometrics; Biostatistics and Biometrics Open Access Journal; Open Access Journals; biometrics journal; biometrics articles; biometrics journal reference; biometrics journal impact factor; biometrics and biostatistics journal impact factor; journal of biometrics; open access juniper publishers; juniper publishers reivew (search for similar items in EconPapers)
Date: 2018
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Persistent link: https://EconPapers.repec.org/RePEc:adp:jbboaj:v:5:y:2018:i:3:p:77-83

DOI: 10.19080/BBOAJ.2018.05.555663

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