3 papers
stat.ME2026
Towards Best Practices for Covariate Adjustment in Regulatory Trials: From Fixed to Data-Adaptive Approaches
Laura B. Balzer, Lei Nie, Issa J. Dahabreh +15
While randomization justifies the use of unadjusted effect estimators in randomized trials, there is growing interest in covariate adjustment to improve precision. Adjusting for ba…
stat.ME2026
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…
stat.ME2024
A Surrogate Endpoint Based Provisional Approval Causal Roadmap
Peter B. Gilbert, James Peng, Larry Han +12
For many rare diseases with no approved preventive interventions, promising interventions exist, yet it has been difficult to conduct a pivotal phase 3 trial that could provide dir…