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A simple device for balancing for a continuous covariate in clinical trials is to stratify by whether the covariate is above or below some target value, typically the predicted median. This raises an issue as to which model should be used…

统计方法学 · 统计学 2025-10-24 Stephen Senn , Franz König , Martin Posch

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

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

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

Adjusting for covariates is a well established method to estimate the total causal effect of an exposure variable on an outcome of interest. Depending on the causal structure of the mechanism under study there may be different adjustment…

统计理论 · 数学 2021-04-27 Jack Kuipers , Giusi Moffa

In randomized experiments, covariates are often used to reduce variance and improve the precision of treatment effect estimates. However, in many real-world settings, interference between units, where one unit's treatment affects another's…

统计方法学 · 统计学 2026-04-10 Xinyi Wang , Shuangning Li

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

Covariate adjustment is a general method for improving precision when estimating treatment effects in randomized trials and is recommended by the FDA in its 2023 guidance when baseline variables are prognostic for the primary outcome. We…

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

Randomization, as a key technique in clinical trials, can eliminate sources of bias and produce comparable treatment groups. In randomized experiments, the treatment effect is a parameter of general interest. Researchers have explored the…

统计方法学 · 统计学 2023-12-05 Fuyi Tu , Wei Ma , Hanzhong Liu

A result from a standard linear model course is that the variance of the ordinary least squares (OLS) coefficient of a variable will never decrease when including additional covariates. The variance inflation factor (VIF) measures the…

统计方法学 · 统计学 2020-06-08 Peng Ding

Higher-Order Influence Functions (HOIF), developed in a series of papers over the past twenty years, are a fundamental theoretical device for constructing rate-optimal causal-effect estimators from observational studies. However, the value…

统计方法学 · 统计学 2025-11-19 Sihui Zhao , Xinbo Wang , Lin Liu , Xin Zhang

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…

统计方法学 · 统计学 2025-08-15 Wanjia Fu , Yingying Ma , Hanzhong Liu

Randomized experiments are the gold standard for causal inference, and justify simple comparisons across treatment groups. Regression adjustment provides a convenient way to incorporate covariate information for additional efficiency. This…

统计方法学 · 统计学 2022-10-25 Anqi Zhao , Peng Ding

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

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

Covariate adjustment is an important tool in the analysis of randomized clinical trials and observational studies. It can be used to increase efficiency and thus power, and to reduce possible bias. While most statistical tests in randomized…

统计方法学 · 统计学 2011-08-03 Xiaoru Wu , Zhiliang Ying

Group sequential designs in clinical trials allow for interim efficacy and futility monitoring. Adjustment for baseline covariates can increase power and precision of estimated effects. However, inconsistently applying covariate adjustment…

统计方法学 · 统计学 2023-08-11 Marlena S. Bannick , Sonya L. Heltshe , Noah Simon

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

One fundamental statistical question for research areas such as precision medicine and health disparity is about discovering effect modification of treatment or exposure by observed covariates. We propose a semiparametric framework for…

统计方法学 · 统计学 2020-08-04 Muxuan Liang , Menggang Yu
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