Methods for detecting outlying regions and influence diagnosis in multi-regional clinical trials-Reference-Cited by-同舟云学术

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Methods for detecting outlying regions and influence diagnosis in multi-regional clinical trials

Published:2021-01-02 Issue:1 Volume:5 Page:30-48
ISSN:2470-9360
Container-title:Biostatistics & Epidemiology
language:en
Short-container-title:Biostatistics & Epidemiology

Author:

Aoki Makoto¹²^ORCID,Noma Hisashi³^ORCID,Gosho Masahiko⁴^ORCID

Affiliation:

1. Department of Statistical Science, School of Multidisciplinary Sciences, The Graduate University for Advanced Studies, Tokyo, Japan

2. Integrated Biostatistics Department, Novartis Pharma K. K., Tokyo, Japan

3. Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan

4. Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan

Funder

Japan Society for the Promotion of Science

Publisher

Informa UK Limited

Subject

Health Informatics,Epidemiology

Link

https://www.tandfonline.com/doi/pdf/10.1080/24709360.2021.1921944

Reference40 articles.

1. Empirical shrinkage estimator for consistency assessment of treatment effects in multi-regional clinical trials

2. International Conference Harmonization. General principles for planning and design of multi-regional clinical trials. 2017. Available at: https://database.ich.org/sites/default/files/E17EWG_Step4_2017_1116.pdf.

3. Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials

4. Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review

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

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