3 papers
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…
stat.AP2024
Semiparametric Piecewise Accelerated Failure Time Model for the Analysis of Immune-Oncology Clinical Trials
Hisato Sunami, Satoshi Hattori
Effectiveness of immune-oncology chemotherapies has been presented in recent clinical trials. The Kaplan-Meier estimates of the survival functions of the immune therapy and the con…