Theoretical Properties of Covariate-Adaptive Randomization with a Diverging Number of Covariates
Covariate-adaptive randomization procedures are widely used in clinical trials to improve covariate balance. In modern applications, experimenters often have access to many covariates, motivating the need for a theory of covariate-adaptive randomization procedures with a diverging number of covariates. This paper studies two classes of covariate-adaptive randomization procedures, referred to as imbalance-efficient covariate-adaptive randomization and imbalance-robust covariate-adaptive randomization, when the feature dimension diverges. We derive convergence rates for the imbalance of the covariates used in randomization. For both procedures, the imbalance is of a smaller order than that under complete randomization when the feature dimension is $o(n)$, whereas it is of the same order when the feature dimension is $Ω(n)$. For imbalance-robust covariate-adaptive randomization, we further establish the asymptotic properties of the imbalance of additional covariates and use these results to derive the asymptotic distribution of the difference-in-means estimator for the average treatment effect and construct asymptotically valid confidence intervals. Furthermore, we provide extensive numerical and empirical studies to illustrate the practical relevance of our theoretical results.