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- 越水 孝
- バイエル薬品株式会社 開発部門
書誌事項
- タイトル別名
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- Statistical Considerations on Bridging Strategy through Joining a Multi-regional Study
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説明
For bridging clinical data, a study is additionally conducted in new region to demonstrate some similarity in treatment effects between two regions. An alternative bridging strategy is that new region participates in a multi-regional study as one site. This paper focuses on a possibility of bridging through joining multi-regional study, and statistical inference for an interaction term between treatment and region to detect non-similarity of treatment effects among regions/countries. Applying a logistic model with the terms of treatment effect, regional effect and their interaction to dichotomous response data, a simulation study is performed to investigate statistical power to detect significant treatment-by-region interaction, and treatment effect for a variety of sample size configurations. The result suggests that moderate or large sample sizes are required in new region to achieve sufficient power, if a substantial (qualitative or quantitative) interaction exists.
収録刊行物
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- 計量生物学
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計量生物学 24 (Special_Issue), S99-S104, 2003
日本計量生物学会
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詳細情報 詳細情報について
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- CRID
- 1390282679346318976
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- NII論文ID
- 130002151777
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- ISSN
- 21856494
- 09184430
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- データソース種別
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- JaLC
- Crossref
- CiNii Articles
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- 抄録ライセンスフラグ
- 使用不可