10 citations · 11 across the 3 of their papers we have counts for
3 papers
stat.AP2023★ 1 cited
Sensitivity analysis for causality in observational studies for regulatory science
Iván Díaz, Hana Lee, Emre Kıcıman +3
Recognizing the importance of real-world data (RWD) for regulatory purposes, the United States (US) Congress passed the 21st Century Cures Act1 mandating the development of Food an…
stat.ME2023★ 10 cited
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…
stat.AP2022
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…