Covariate selection for optimizing balance with an innovative adaptive randomization approach

Balancing influential covariates is crucial for valid treatment comparisons in clinical studies. While covariate-adaptive randomization is commonly used to achieve balance, its performance can be inadequate when the number of baseline covariates is large. It is, therefore, essential to identify the influential factors associated with the outcome and ensure balance among these critical covariates. In this article, we propose a novel adaptive randomization approach that integrates the patients' responses and covariates information to select sequentially significant covariates and maintain their balance. We establish theoretically the consistency of our covariate selection method and demonstrate that the improved covariate balancing, as evidenced by a faster convergence rate of the imbalance measure, leads to higher efficiency in estimating treatment effects. Furthermore, we provide extensive numerical and empirical studies to illustrate the benefits of our proposed method across various settings.

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Publication Details

Journal
Statistical Methods in Medical Research
Published
2025-04-13
DOI
https://doi.org/10.1177/09622802241313283
Primary Topic
Optimal Experimental Design Methods
Type
article
Field-Weighted Citation Impact
0.00

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article

Covariate selection for optimizing balance with an innovative adaptive randomization approach

Lucy Xia, Yang Liu, Z. Z. Guo
Statistical Methods in Medical Research
Optimal Experimental Design Methods
article

Covariate selection for optimizing balance with an innovative adaptive randomization approach

Lucy Xia, Yang Liu, Z. Z. Guo
article en

Abstract

Balancing influential covariates is crucial for valid treatment comparisons in clinical studies. While covariate-adaptive randomization is commonly used to achieve balance, its performance can be inadequate when the number of baseline covariates is large. It is, therefore, essential to identify the influential factors associated with the outcome and ensure balance among these critical covariates. In this article, we propose a novel adaptive randomization approach that integrates the patients' responses and covariates information to select sequentially significant covariates and maintain their balance. We establish theoretically the consistency of our covariate selection method and demonstrate that the improved covariate balancing, as evidenced by a faster convergence rate of the imbalance measure, leads to higher efficiency in estimating treatment effects. Furthermore, we provide extensive numerical and empirical studies to illustrate the benefits of our proposed method across various settings.

Statistical Methods in Medical ResearchVol. 34(9)
Hong Kong University of Science and Technology (HK), Renmin University of China (CN)
National Natural Science Foundation of China
Openalex Percentile: Top 92%
Optimal Experimental Design Methods
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