10 citations · 17 across the 5 of their papers we have counts for
5 papers
Considerations for the Integration of Randomized Controlled Trials and Real-World Data
Sky Qiu, Charles Barr, Lauren Dang +18
As clinical decision-making increasingly moves toward individualized and context-specific treatment recommendations, reliance on any single evidence source, randomized or observati…
A Causal Roadmap for Hybrid Randomized and Real-World Data Designs: Case Study of Semaglutide and Cardiovascular Outcomes
Lauren E Dang, Edwin Fong, Jens Magelund Tarp +6
Introduction: Increasing interest in real-world evidence has fueled the development of study designs incorporating real-world data (RWD). Using the Causal Roadmap, we specify three…
An Application of the Causal Roadmap in Two Safety Monitoring Case Studies: Covariate-Adjustment and Outcome Prediction using Electronic Health Record Data
Brian D Williamson, Richard Wyss, Elizabeth A Stuart +4
Real-world data, such as administrative claims and electronic health records, are increasingly used for safety monitoring and to help guide regulatory decision-making. In these set…
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…
Experiment-selector cross-validated targeted maximum likelihood estimator for hybrid RCT-external data studies
Lauren Eyler Dang, Jens Magelund Tarp, Trine Julie Abrahamsen +4
Augmenting a randomized controlled trial (RCT) with external data may increase power at the risk of introducing bias. To select and analyze the experiment (RCT alone or combined wi…