6 papers
A seamless dose-optimization design for monotherapy and combination therapy
Kentaro Takeda, Masahiro Kojima
The emergence of molecular-targeted agents and immune-oncology therapies has fundamentally transformed oncology drug development, necessitating evolution beyond traditional dose-fi…
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…
Fast Power Evaluation under Biased-Coin Minimization: Sampling and Randomization Calibration
Masahiro Kojima
Design-stage power and sample-size evaluation under biased-coin minimization can be computationally intensive when a prespecified randomization test is reproduced within every simu…
Covariate-Adaptive Sample Size Re-estimation for Population-Standardized Historical Control Designs in Single-Arm Trials
Keisuke Hanada, Masahiro Kojima
Externally controlled single-arm trials are increasingly considered when randomized controls are infeasible, but baseline imbalance between the active-arm trial and historical cont…
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…
Sample size re-estimation in blinded hybrid-control design using inverse probability weighting
Masahiro Kojima, Shunichiro Orihara, Keisuke Hanada +1
With the increasing availability of data from historical studies and real-world data sources, hybrid control designs that incorporate external data into the evaluation of current s…