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Author

Toshihiro Misumi

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Aug 2026

Reproducibility of overall survival in metastatic colorectal cancer randomized trials using ARCAD-Derived external control arms.

ARCAD-derived SCAs reliably reproduced control-arm OS and benchmark treatment-effect estimates from landmark RCTs in mCRC, and supports benchmarking, trial design, and exploratory analyses when conventional control arms are impractical.

M. Raeisi, T. André, Q. Shi et al. · 0 citations
Review Open access Aug 2026

Recommendations for generating real-world evidence with regulatory-grade relevance and reliability

A purpose-oriented framework clarifying the levels of relevance and reliability required according to specific regulatory objectives is proposed, and practical recommendations for generating regulatory-grade RWE that meaningfully informs regulatory decision-making while complementing conventional clinical trials are pr...

Yasutoshi Sakamoto, H. Bando, Yoshihiro Aoyagi et al. · 0 citations

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