8 papers · 1 filter
Validity of MMRM-based hypothesis testing under missing-not-at-random mechanisms
Kazushi Maruo, Ryota Ishii, Yusuke Yamaguchi +3
In randomized clinical trials with longitudinal continuous outcomes, missing-not-at-random (MNAR) missingness often motivates conservative alternatives to mixed models for repeated…
Outcome-blinded sample size re-estimation for externally controlled single-arm trials using baseline covariates
Keisuke Hanada, Masahiro Kojima
Externally controlled single-arm trials provide an option when limited patient populations or ethical constraints make concurrent randomized controls impractical, including in rare…
Differentially Private One-Shot Federated Inference for Linear Mixed Models via Lossless Likelihood Reconstruction
Keisuke Hanada, Toshio Shimokawa, Kazushi Maruo
One-shot federated learning enables multi-site inference with minimal communication. However, sharing summary statistics can still leak sensitive individual-level information when…
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…
A Clustering Approach for Basket Trials Based on Treatment Response Trajectories
Masahiro Kojima, Keisuke Hanada, Atsuya Sato
Heterogeneity in efficacy is sometimes observed across baskets in basket trials. In this study, we propose a model-free clustering framework that groups baskets based on transition…
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…
Bayesian Parametric Methods for Deriving Distribution of Restricted Mean Survival Time
Keisuke Hanada, Masahiro Kojima
We propose a Bayesian method for deriving the distribution of restricted mean survival time (RMST) using posterior samples, which accounts for covariates and heterogeneity among cl…
Random Effect Restricted Mean Survival Time Model
Keisuke Hanada, Masahiro Kojima
The restricted mean survival time (RMST) model has been garnering attention as a way to provide a clinically intuitive measure: the mean survival time. RMST models, which use metho…