3 papers
stat.ME2026
Implementing the principal stratum strategy for intercurrent events with survival outcomes: a tutorial
Xiaoxiao Zhou, Joyce Chen, Pallavi Mishra-Kalyani +5
The International Council for Harmonization (ICH) E9 (R1) addendum provides the estimand framework to formulate treatment effects in a clinical trial. One of the attributes of an e…
stat.ME2026
Externally Controlled Trials: A Review of Design and Borrowing Through a Causal Lens
Ke Zhu, Rima Izem, Peng Yang +8
Externally controlled trials (ECTs) are increasingly used when randomized controls are infeasible, unethical, or insufficient, including applications in rare diseases, oncology, pe…
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…