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Published in 2023 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2023.2170395
Abstract: In multi-regional clinical trials, hierarchical linear models have been actively studied because they can reflect that patients in the same region share common intrinsic and extrinsic factors. In this paper, we investigate the statistical properties…
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Keywords:
effect;
multi regional;
linear model;
hierarchical linear ... See more keywords
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Published in 2023 at "Biometrics"
DOI: 10.1111/biom.13820
Abstract: Sponsors often rely on multi-regional clinical trials (MRCTs) to introduce new treatments more rapidly into the global market. Many commonly used statistical methods do not account for regional differences, and small regional sample sizes frequently…
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Keywords:
time event;
treatment effects;
clinical trials;
multi regional ... See more keywords