Use of likelihood estimates for variances for the design and evaluation of multiregional clinical trials with heterogeneous variances-Reference-Cited by-同舟云学术

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Use of likelihood estimates for variances for the design and evaluation of multiregional clinical trials with heterogeneous variances

Published:2021-10-27 Issue:1 Volume:41 Page:87-107
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Wu Yuh‐Jenn¹,Cheng Yu‐Chieh²^ORCID,Chiang Chieh³,Cheng Li‐Hsueh²,Liu Ching‐Ti⁴^ORCID,Hsiao Chin‐Fu²^ORCID

Affiliation:

1. Department of Applied Mathematics Chung Yuan Christian University Taoyuan Taiwan

2. Institute of Population Health Sciences National Health Research Institutes Zhunan Taiwan

3. Department of Mathematics Tamkang University New Taipei Taiwan

4. Department of Biostatistics Boston University School of Public Health Boston Massachusetts USA

Funder

Ministry of Science and Technology, Taiwan

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.9224

Reference16 articles.

1. Ministry of Health Labor and Welfare of Japan (MHLW)Basic principles on global clinical trials; 2007.http://www.pmda.go.jp/files/000153265.pdf. Accessed December 10 2020.

2. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.ICH E17: general principles for planning and design of multi‐regional clinical trials (draft); 2016.

3. Sample size considerations for Japanese patients in a multi-regional trial based on MHLW guidance

4. An Approach to Rationalize Partitioning Sample Size into Individual Regions in a Multiregional Trial

5. Sample Size Allocation to Regions in a Multiregional Trial

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