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Simulation-Based Assessment of Covariate Adjustment in Randomized Trials

CRAN Package

Monte Carlo simulation framework for different randomized clinical trial designs with a special emphasis on estimators based on covariate adjustment. The package implements regression-based covariate adjustment (Rosenblum & van der Laan (2010) <doi:10.2202/1557-4679.1138>) and a one-step estimator (Van Lancker et al (2024) <doi:10.48550/arXiv.2404.11150>) for trials with continuous, binary and count outcomes. The estimation of the minimum sample-size required to reach a specified statistical power for a given estimator uses bisection to find an initial rough estimate, followed by stochastic approximation (Robbins-Monro (1951) <doi:10.1214/aoms/1177729586>) to improve the estimate, and finally, a grid search to refine the estimate in the neighborhood of the current best solution.


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