134 citations · 150 across the 6 of their papers we have counts for
6 papers
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…
A Causal Roadmap for Generating High-Quality Real-World Evidence
Lauren E Dang, Susan Gruber, Hana Lee +23
Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks…
Evaluating and improving real-world evidence with Targeted Learning
Susan Gruber, Rachael V. Phillips, Hana Lee +2
Purpose: The Targeted Learning roadmap provides a systematic guide for generating and evaluating real-world evidence (RWE). From a regulatory perspective, RWE arises from diverse s…
Targeted learning: Towards a future informed by real-world evidence
Susan Gruber, Rachael V. Phillips, Hana Lee +3
The 21st Century Cures Act of 2016 includes a provision for the U.S. Food and Drug Administration (FDA) to evaluate the potential use of real-world evidence (RWE) to support new in…
Practical considerations for specifying a super learner
Rachael V. Phillips, Mark J. van der Laan, Hana Lee +1
Common tasks encountered in epidemiology, including disease incidence estimation and causal inference, rely on predictive modeling. Constructing a predictive model can be thought o…
Scalable Collaborative Targeted Learning for High-Dimensional Data
Cheng Ju, Susan Gruber, Samuel D. Lendle +5
Robust inference of a low-dimensional parameter in a large semi-parametric model relies on external estimators of infinite-dimensional features of the distribution of the data. Typ…