7 papers
Robust Estimation and Inference with Selective Borrowing in Hybrid Controlled Trials: A Tutorial with SelectiveIntegrative and intFRT
Ke Zhu, Hairong Huang, Shu Yang +1
Hybrid controlled trials (HCTs) augment randomized controlled trials (RCTs) with external controls (ECs) to improve statistical efficiency when RCTs face limited sample sizes, slow…
A Conformal Selection Framework for Individual Treatment Beneficiaries with Auxiliary External Data
Jiajun Liu, Ke Zhu, Xiaofei Wang
Identifying patients who are likely to benefit from a treatment is central to precision medicine and can guide follow-up trials, enrichment designs, and individualized decisions. A…
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…
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…
Enhancing Statistical Validity and Power in Hybrid Controlled Trials: A Randomization Inference Approach with Conformal Selective Borrowing
Ke Zhu, Shu Yang, Xiaofei Wang
External controls from historical trials or observational data can augment randomized controlled trials when large-scale randomization is impractical or unethical, such as in drug…
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…