Author

M. Kojima

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Preprint Sep 2026

A staggered seamless dose-optimization design for co-developing monotherapy and combination therapy

Contemporary oncology drug development increasingly requires efficient dose-optimization strategies that evaluate monotherapy (Mono) and combination therapy (Combo) while balancing activity, efficacy, and tolerability. We propose a staggered seamless phase I/II design for settings in which a novel agent is evaluated al...

M. Kojima, Kentaro Takeda, Ying Yuan · 0 citations

Open access Mar 2025

Integrating Meta-Analysis Into a Specific Study (InMASS) for Estimating the Target-Population Average Treatment Effect.

Randomized controlled trials remain the benchmark for estimating treatment effects, yet practical constraints often restrict sample sizes in a prespecified target population. In such settings, evidence from completed trials is frequently available only in aggregate form, which precludes direct individual-level integrat...

Keisuke Hanada, M. Kojima · Biometrical journal. Biometr... · 1 citation

Preprint Sep 2026

Feedback-Aware Tuning of Recursive Q-Learning

This work treats the entire backward-fitting rule as the unit of comparison and proposes feedback-aware soft tuning for sequential multiple assignment randomised trials and an exact risk identity under a Gaussian shift model and an oracle inequality with an explicit adaptation remainder under coordinate-representation...

M. Kojima · 0 citations

Preprint Aug 2026

Fast Power Evaluation under Biased-Coin Minimization: Sampling and Randomization Calibration

Design-stage power and sample-size evaluation under biased-coin minimization can be computationally intensive when a prespecified randomization test is reproduced within every simulated trial. We develop a reusable stratum-imbalance Gaussian approximation (SIGA) framework by exactly decomposing a fixed-score statistic...

M. Kojima · 0 citations