10 citations · 16 across the 5 of their papers we have counts for
5 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…
Estimands in Real-World Evidence Studies
Jie Chen, Daniel Scharfstein, Hongwei Wang +6
A Real-World Evidence (RWE) Scientific Working Group (SWG) of the American Statistical Association Biopharmaceutical Section (ASA BIOP) has been reviewing statistical consideration…
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…