Regression adjustment in covariate-adaptive randomized experiments with missing covariates

Fuente: arXiv
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Auteurs principaux: Fu, Wanjia, Ma, Yingying, Liu, Hanzhong
Format: Preprint
Publié: 2025
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author Fu, Wanjia
Ma, Yingying
Liu, Hanzhong
author_facet Fu, Wanjia
Ma, Yingying
Liu, Hanzhong
contents Covariate-adaptive randomization is widely used in clinical trials to balance prognostic factors, and regression adjustments are often adopted to further enhance the estimation and inference efficiency. In practice, the covariates may contain missing values. Various methods have been proposed to handle the covariate missing problem under simple randomization. However, the statistical properties of the resulting average treatment effect estimators under stratified randomization, or more generally, covariate-adaptive randomization, remain unclear. To address this issue, we investigate the asymptotic properties of several average treatment effect estimators obtained by combining commonly used missingness processing procedures and regression adjustment methods. Moreover, we derive consistent variance estimators to enable valid inferences. Finally, we conduct a numerical study to evaluate the finite-sample performance of the considered estimators under various sample sizes and numbers of covariates and provide recommendations accordingly. Our analysis is model-free, meaning that the conclusions remain asymptotically valid even in cases of misspecification of the regression model.
format Preprint
id arxiv_https___arxiv_org_abs_2508_10061
institution arXiv
publishDate 2025
record_format arxiv
spellingShingle Regression adjustment in covariate-adaptive randomized experiments with missing covariates
Fu, Wanjia
Ma, Yingying
Liu, Hanzhong
Methodology
Statistics Theory
Covariate-adaptive randomization is widely used in clinical trials to balance prognostic factors, and regression adjustments are often adopted to further enhance the estimation and inference efficiency. In practice, the covariates may contain missing values. Various methods have been proposed to handle the covariate missing problem under simple randomization. However, the statistical properties of the resulting average treatment effect estimators under stratified randomization, or more generally, covariate-adaptive randomization, remain unclear. To address this issue, we investigate the asymptotic properties of several average treatment effect estimators obtained by combining commonly used missingness processing procedures and regression adjustment methods. Moreover, we derive consistent variance estimators to enable valid inferences. Finally, we conduct a numerical study to evaluate the finite-sample performance of the considered estimators under various sample sizes and numbers of covariates and provide recommendations accordingly. Our analysis is model-free, meaning that the conclusions remain asymptotically valid even in cases of misspecification of the regression model.
title Regression adjustment in covariate-adaptive randomized experiments with missing covariates
topic Methodology
Statistics Theory
url https://arxiv.org/abs/2508.10061