10 papers
An Estimator-Robust Design for Augmenting Randomized Controlled Trials with External Real-World Data
Sky Qiu, Jens Tarp, Andrew Mertens +1
Augmenting randomized controlled trials (RCTs) with external real-world data (RWD) has the potential to improve the finite sample efficiency of treatment effect estimators. We desc…
Improving the Efficiency of Subgroup Analysis in Randomized Controlled Trials with TMLE
Sky Qiu, Nerissa Nance, Rachael Phillips +3
Subgroup analyses within randomized controlled trials are often underpowered due to limited sample sizes. We address this challenge by leveraging trial participants outside the sub…
Estimation of treatment effects in presence of differential use of post-randomization concomitant medication with time-to-event outcomes
Helene C. W. Rytgaard, Edwin Fong, Jens M. Tarp +3
In placebo-controlled randomized trials, the post-randomization use of concomitant medications may be higher in the placebo arm than in the treatment arm. This may dilute the full…
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…
Causal-ICM: A Data Fusion Framework For Heterogeneous Treatment Effect Estimation With Multi-Task Gaussian Processes
Evangelos Dimitriou, Edwin Fong, Jens Magelund Tarp +2
Bridging the gap between internal and external validity is crucial for heterogeneous treatment effect estimation. Randomised controlled trials (RCTs), favoured for their internal v…
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…