Toward Better Practice of Covariate Adjustment in Analyzing Randomized Clinical Trials

• Published in: Journal of the American Statistical Association Vol. 118; no. 544; pp. 2370 - 2382
• Main Authors: Ye, Ting, Shao, Jun, Yi, Yanyao, Zhao, Qingyuan
• Format: Journal Article
• Language: English
• Published: Alexandria Taylor & Francis 02.10.2023; Taylor & Francis Ltd
• Subjects: Adjustment; Analysis of covariance; Asymptotic properties; Clinical research; Clinical trials; covariance; Covariate-adaptive randomization; Efficiency; Heteroscedasticity; heteroskedasticity; Inference; mathematical theory; Model-assisted; Multiple treatment arms; Randomization; Regulatory agencies; Relevance; Robustness; Standard error; Statistical analysis; Statistics; Treatment-by-covariate interaction; variance

In randomized clinical trials, adjustments for baseline covariates at both design and analysis stages are highly encouraged by regulatory agencies. A recent trend is to use a model-assisted approach for covariate adjustment to gain credibility and efficiency while producing asymptotically valid infe...