4 papers
Selective Information Borrowing for Region-Specific Treatment Effect Inference under Covariate Mismatch in Multi-Regional Clinical Trials
Chenxi Li, Ke Zhu, Shu Yang +1
Multi-regional clinical trials (MRCTs) are central to global drug development, enabling evaluation of treatment effects across diverse populations. A key challenge is valid and eff…
Robust Estimation and Inference in Hybrid Controlled Trials for Binary Outcomes: A Case Study on Non-Small Cell Lung Cancer
Jiajun Liu, Ke Zhu, Shu Yang +1
Hybrid controlled trials (HCTs), which augment randomized controlled trials (RCTs) with external controls (ECs), are increasingly receiving attention as a way to address limited po…
Integrative Analysis of High-dimensional RCT and RWD Subject to Censoring and Hidden Confounding
Xin Ye, Shu Yang, Xiaofei Wang +1
In this study, we focus on estimating the heterogeneous treatment effect (HTE) for survival outcome. The outcome is subject to censoring and the number of covariates is high-dimens…
Statistical Inference for Heterogeneous Treatment Effect with Right-censored Data from Synthesizing Randomized Clinical Trials and Real-world Data
Guangcai Mao, Shu Yang, Xiaofei Wang
The heterogeneous treatment effect plays a crucial role in precision medicine.There is evidence that real-world data, even subject to biases, can be employed as supplementary evide…