3 papers
stat.ME2023
Dynamic Borrowing Method for Historical Information Using a Frequentist Approach for Hybrid Control Design
Masahiro Kojima
Information borrowing from historical data is gaining attention in clinical trials of rare and pediatric diseases, where statistical power may be insufficient for confirmation of e…
stat.ME2023
Adaptive Cohort Size Determination Method for Bayesian Optimal Interval Phase I/II Design to Shorten Clinical Trial Duration
Masahiro Kojima
Recently, the strategy for dose optimization in oncology has shifted to conduct Phase 2 randomized controlled trials with multiple doses. Optimal biologic dose selection from Phase…
stat.ME2023
Frailty Model with Change Point for Survival Analysis
Masahiro Kojima, Shunichiro Orihara
We propose a novel frailty model with change points applying random effects to a Cox proportional hazard model to adjust the heterogeneity between clusters. Because the frailty mod…