3 papers
stat.ME2025
Sensitivity Analysis for Unmeasured Confounding in Medical Product Development and Evaluation Using Real World Evidence
Yixin Fang, Pallavi Mishra-Kalyani, Xiang Zhang +8
The American Statistical Association Biopharmaceutical Section (ASA BIOP) scientific working group on real-world evidence (RWE) has been making continuous, extended efforts towards…
stat.ME2025
Doubly protected estimation for survival outcomes utilizing external controls for randomized clinical trials
Chenyin Gao, Shu Yang, Mingyang Shan +3
Censored survival data are common in clinical trials, but small control groups can pose challenges, particularly in rare diseases or where balanced randomization is impractical. Re…
stat.ME2024
Improving randomized controlled trial analysis via data-adaptive borrowing
Chenyin Gao, Shu Yang, Mingyang Shan +3
In recent years, real-world external controls have grown in popularity as a tool to empower randomized placebo-controlled trials, particularly in rare diseases or cases where balan…