3 citations · 3 across the 5 of their papers we have counts for
4 papers · 1 filter
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…
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…
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…
Propensity Process: a Balancing Functional
Pallavi S. Mishra-Kalyani, Brent A. Johnson, Qi Long
In observational clinic registries, time to treatment is often of interest, but treatment can be given at any time during follow-up and there is no structure or intervention to ens…