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In conventional randomized controlled trials, adjustment for baseline values of covariates known to be at least moderately associated with the outcome increases the power of the trial. Recent work has shown particular benefit for more…

统计方法学 · 统计学 2023-11-27 James Willard , Shirin Golchi , Erica EM Moodie

Benkeser et al. demonstrate how adjustment for baseline covariates in randomized trials can meaningfully improve precision for a variety of outcome types. Their findings build on a long history, starting in 1932 with R.A. Fisher and…

统计方法学 · 统计学 2026-03-03 Laura B. Balzer , Erica Cai , Lucas Godoy Garraza , Pracheta Amaranath

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…

统计方法学 · 统计学 2021-07-14 Ting Ye , Jun Shao , Yanyao Yi , Qingyuan Zhao

In clinical trials, there is potential to improve precision and reduce the required sample size by appropriately adjusting for baseline variables in the statistical analysis. This is called covariate adjustment. Despite recommendations by…

统计方法学 · 统计学 2022-06-20 Kelly Van Lancker , Joshua Betz , Michael Rosenblum

Covariate adjustment aims to improve the statistical efficiency of randomized trials by incorporating information from baseline covariates. Popular methods for covariate adjustment include analysis of covariance for continuous endpoints and…

统计方法学 · 统计学 2025-05-09 Zhiwei Zhang , Ya Wang , Dong Xi

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…

统计方法学 · 统计学 2024-12-30 Ziqing Guo , Yang Liu , Lucy Xia

There has been a growing interest in covariate adjustment in the analysis of randomized controlled trials in past years. For instance, the U.S. Food and Drug Administration recently issued guidance that emphasizes the importance of…

统计方法学 · 统计学 2023-06-12 Kelly Van Lancker , Frank Bretz , Oliver Dukes

Covariate adjustment is widely recommended to improve statistical efficiency in randomized clinical trials (RCTs), yet empirical evidence comparing available strategies remains limited. This lack of real-world evaluation leaves unresolved…

应用统计 · 统计学 2026-02-03 Yulin Shao , Liangbo Lyu , Menggang Yu , Bingkai Wang

When analyzing data from randomized clinical trials, covariate adjustment can be used to account for chance imbalance in baseline covariates and to increase precision of the treatment effect estimate. A practical barrier to covariate…

统计方法学 · 统计学 2023-07-04 Chia-Rui Chang , Yue Song , Fan Li , Rui Wang

This paper studies covariate adjusted estimation of the average treatment effect in stratified experiments. We work in a general framework that includes matched tuples designs, coarse stratification, and complete randomization as special…

计量经济学 · 经济学 2024-07-23 Max Cytrynbaum

The statistical efficiency of randomized clinical trials can be improved by incorporating information from baseline covariates (i.e., pre-treatment patient characteristics). This can be done in the design stage using stratified (permutated…

统计方法学 · 统计学 2025-02-04 Zhiwei Zhang

To maximize clinical benefit, clinicians routinely tailor treatment to the individual characteristics of each patient, where individualized treatment rules are needed and are of significant research interest to statisticians. In the…

统计方法学 · 统计学 2021-11-23 Trinetri Ghosh , Yanyuan Ma , Rui Song , Pingshou Zhong

Purpose: Covariate adjustment is a powerful statistical technique that can increase efficiency in clinical trials. Recent guidance from the U.S. FDA provided recommendations and best practices for using covariate adjustment. However, there…

Variable selection for optimal treatment regime in a clinical trial or an observational study is getting more attention. Most existing variable selection techniques focused on selecting variables that are important for prediction, therefore…

统计方法学 · 统计学 2014-05-22 Ailin Fan , Wenbin Lu , Rui Song

We investigate how to improve efficiency using regression adjustments with covariates in covariate-adaptive randomizations (CARs) with imperfect subject compliance. Our regression-adjusted estimators, which are based on the doubly robust…

计量经济学 · 经济学 2023-06-19 Liang Jiang , Oliver B. Linton , Haihan Tang , Yichong Zhang

We often seek to estimate the causal effect of an exposure on a particular outcome in both randomized and observational settings. One such estimation method is the covariate-adjusted residuals estimator, which was designed for individually…

统计方法学 · 统计学 2019-10-28 Stephen A. Lauer , Nicholas G. Reich , Laura B. Balzer

There has been a split in the statistics community about the need for taking covariates into account in the design phase of a clinical trial. There are many advocates of using stratification and covariate-adaptive randomization to promote…

统计方法学 · 统计学 2011-02-21 William F. Rosenberger , Oleksandr Sverdlov

We consider a problem of ranking and selection via simulation in the context of personalized decision making, where the best alternative is not universal but varies as a function of some observable covariates. The goal of ranking and…

机器学习 · 统计学 2022-02-09 Haihui Shen , L. Jeff Hong , Xiaowei Zhang

Covariate adjustment can enhance precision and power in clinical trials, yet its application to the win odds remains unclear. The win odds is an extension of the win ratio that counts ties as half a win for the treatment and the control…

统计方法学 · 统计学 2026-04-08 Cyrill Scheidegger , Simon Wandel , Tobias Mütze

Analyses of randomised trials are often based on regression models which adjust for baseline covariates, in addition to randomised group. Based on such models, one can obtain estimates of the marginal mean outcome for the population under…

统计方法学 · 统计学 2017-07-17 Jonathan W. Bartlett
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