私は主に医療統計学の方法論について研究しており、特に臨床試験の迅速化に関心を持っています。臨床開発の効率性・信頼性・倫理的健全性を高める統計手法の開発と応用を目指しています。
これまでには、第I相がん臨床試験における早期終了法に関する研究に取り組み、効果が不十分または安全性に問題のある治療法に対する患者の曝露を最小限に抑えることを目的としてきました。現在は、第I/II相の腫瘍学的臨床試験の加速に研究領域を広げており、より迅速かつ効率的な用量探索と有効性評価を可能にするデザインの検討を行っています。
また、外部対照を用いた試験において、新たな第I相試験デザインや統計手法の開発にも携わっており、試験結果の解釈可能性と一般化可能性の向上を目指しています。
これらの研究を通じて、臨床試験方法論の発展に貢献し、最終的には医療現場におけるより良い意思決定につながることを目指しています。
Kojima, M. (2025). Early completion based on adjacent dose information for model-assisted designs to accelerate maximum tolerated dose finding. The International Journal of Biostatistics. [paper]
Kojima, M., Wende, W., & Zhao, H. (2024). Tips for Accelerating BOIN Design. Therapeutic Innovation & Regulatory Science, 58(6), 1129-1137. [paper]
Kojima, M. (2023). Application of multi-armed bandits to dose-finding clinical designs. Artificial Intelligence in Medicine, 146, 102713. [paper]
Kojima, M. (2023). Adaptive Cohort Size Determination Method for Bayesian Optimal Interval Phase I/II Design to Shorten Clinical Trial Duration. JCO Precision Oncology, 7, e2300087. [paper]
Kojima, M. (2023). Data-dependent early completion of dose-finding trials for drug-combination. Statistical Methods in Medical Research, 32(4), 820-828. [paper]
Kojima, M. (2022). Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial. BMC Medical Research Methodology, 22(1), 97. [paper]
Kojima, M. (2021). Early completion of model-assisted designs for dose-finding trials. JCO Precision Oncology, 5, 1449-1457. [paper]
Kojima, M. (2021). Early completion of phase I cancer clinical trials with Bayesian optimal interval design. Statistics in Medicine, 40(14), 3215-3226. [paper]
Hanada, K., Moriya, J., & Kojima, M. (2024). Comparison of baseline covariate adjustment methods for restricted mean survival time. Contemporary Clinical Trials, 138, 107440. [paper]
Kojima, M., & Orihara, S. (2024). Frailty model with change points for survival analysis. Pharmaceutical Statistics, 23(3), 408-424. [paper]
Kojima, M. (2023). Variable selection using inverse probability of censoring weighting. Statistical Methods in Medical Research, 32(11), 2184-2206. [paper]
Kojima, M. (2023). DBMS: Dynamic Borrowing Method for Frequentist Hybrid Control Designs Based on Historical-Current Data Similarity. The International Journal of Biostatistics, (in press) []
Kojima, M. (2023). Adjusted closed‐form confidence interval formulas for network meta‐analysis with a small number of studies. Statistics in Medicine, 42(4), 457-469. [paper]
Kojima, M., & Kubokawa, T. (2013). Bartlett-type adjustments for hypothesis testing in linear models with general error covariance matrices. Journal of Multivariate Analysis, 122, 162-174. [paper]
Kojima, M., Mano, H., Yamada, K., Hanada, K., Tanaka, Y., & Moriya, J. (2023). Adjusting confidence intervals under covariate-adaptive randomization in non-inferiority and equivalence trials. Contemporary Clinical Trials, 158. [paper]
He, X., Narushima, K., Kojima, M., Nagai, C., & Li, K. (2024). Pharmacokinetics, Pharmacodynamics, and Safety of Evocalcet (KHK7580), a Novel Calcimimetic Agent: An Open-Label, Single-and Multiple-Dose, Phase I Trial in Healthy Chinese Subjects. Drug Design, Development and Therapy, 567-581. [paper]
Ni, Z., Liang, X., Wu, C. C., Jin, K., Kim, Y. L., Lu, K. C., ... & Yang, S. Y. (2023). Comparison of the oral calcimimetics evocalcet and cinacalcet in east asian patients on hemodialysis with secondary hyperparathyroidism. Kidney International Reports, 8(11), 2294-2306. [paper]
Kojima, M. (2023). Data-dependent contrast test for dose-finding clinical trials. Contemporary Clinical Trials, 131, 107265. [paper]
Nangaku, M., Takama, H., Ichikawa, T., Mukai, K., Kojima, M., Suzuki, Y., ... & Akizawa, T. (2023). Randomized, double-blind, placebo-controlled phase 3 study of bardoxolone methyl in patients with diabetic kidney disease: design and baseline characteristics of the AYAME study. Nephrology Dialysis Transplantation, 38(5), 1204-1216. [paper]
Namba, N., Kubota, T., Muroya, K., Tanaka, H., Kanematsu, M., Kojima, M., ... & Ozono, K. (2022). Safety and efficacy of burosumab in pediatric patients with X-linked hypophosphatemia: a phase 3/4 open-label trial. Journal of the Endocrine Society, 6(5), bvac021. [paper]
Imanishi, Y., Ito, N., Rhee, Y., Takeuchi, Y., Shin, C. S., Takahashi, Y., ... & Fukumoto, S. (2020). Interim analysis of a phase 2 open‐label trial assessing burosumab efficacy and safety in patients with tumor‐induced osteomalacia. Journal of Bone and Mineral Research, 36(2), 262-270. [paper]
Hanada, K., & Kojima, M. (2025). Integrate Meta-analysis into Specific Study (InMASS) for Estimating Conditional Average Treatment Effect. [arXiv]
Kojima, M., Orihara, S., Hanada, K., & Ohigashi, T. (2025). Sample size re-estimation in blinded hybrid-control design using inverse probability weighting. [arXiv]
Hanada, K., & Kojima, M. (2024). Bayesian Parametric Methods for Deriving Distribution of Restricted Mean Survival Time. [arXiv]
Hanada, K., & Kojima, M. (2024). Random Effect Restricted Mean Survival Time Model. [arXiv]