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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.ME2025
Robust Covariate Adjustment in Multi-Center Randomized Trials
Muluneh Alene, Stijn Vansteelandt, Kelly Van Lancker
Augmented inverse probability weighting and G-computation with canonical generalized linear models have become increasingly popular for estimating the average treatment effect (ATE…
stat.ME2024
Automated, efficient and model-free inference for randomized clinical trials via data-driven covariate adjustment
Kelly Van Lancker, Iván Díaz, Stijn Vansteelandt
In 2023, the U.S. Food and Drug Administration issued guidance for adjustment of covariates in randomized clinical trials, emphasizing its role in enhancing precision and power thr…