Statistical Considerations on Bridging Strategy through Joining a Multi-regional Study

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Other Title
  • ブリッジング評価における国際共同試験計画に関する統計学的考察

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Description

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.

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Details 詳細情報について

  • CRID
    1390282679346318976
  • NII Article ID
    130002151777
  • DOI
    10.5691/jjb.24.s99
  • ISSN
    21856494
    09184430
  • Data Source
    • JaLC
    • Crossref
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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