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stat.ME2026
Finite-Boundary Reduction and Exact Verification of Strong Familywise Error in Active-Count-Coupled Multi-Arm Efficacy-Toxicity Monitoring
Masahiro Kojima, Hisato Sunami, Kentaro Takeda
Randomized dose-optimization trials may screen several candidate doses using binary efficacy and toxicity outcomes. A dose is inadmissible if efficacy is insufficient or toxicity i…
stat.ME2026
A Globally Calibrated Bayesian Optimal Phase II Design for Adaptive Enrichment Trials
Masahiro Kojima, Hisato Sunami, Masaaki Kuriki
Adaptive enrichment allows development of an experimental treatment to continue when its activity is insufficient in an all-comer population but remains promising in a prespecified…
stat.ME2026
Hybrid Non-informative and Informative Prior Model-assisted Designs for Mid-trial Dose Insertion
Kana Yamada, Hisato Sunami, Kentaro Takeda +2
In oncology phase I trials, model-assisted designs have been increasingly adopted because they enable adaptive yet operationally simple dose adjustment based on accumulating safety…