Covariate adjustment in randomized controlled trials: General concepts and practical considerations

K Van Lancker, F Bretz, O Dukes - Clinical Trials, 2024 - journals.sagepub.com
There has been a growing interest in covariate adjustment in the analysis of randomized
controlled trials in past years. For instance, the US Food and Drug Administration recently …

A Unified Framework for Covariate Adjustment Under Stratified Randomisation

F Tu, W Ma, H Liu - Stat, 2024 - Wiley Online Library
Randomisation, as a key technique in clinical trials, can eliminate sources of bias and
produce comparable treatment groups. In randomised experiments, the treatment effect is a …

Automated, efficient and model-free inference for randomized clinical trials via data-driven covariate adjustment

K Van Lancker, I Díaz, S Vansteelandt - arXiv preprint arXiv:2404.11150, 2024 - arxiv.org
In May 2023, the US Food and Drug Administration (FDA) released guidance for industry on"
Adjustment for Covariates in Randomized Clinical Trials for Drugs and Biological Products" …

[HTML][HTML] When does adjusting covariate under randomization help? A comparative study on current practices

Y Gao, Y Liu, R Matsouaka - BMC Medical Research Methodology, 2024 - Springer
Purpose We aim to thoroughly compare past and current methods that leverage baseline
covariate information to estimate the average treatment effect (ATE) using data from of …

Incorporating external data for analyzing randomized clinical trials: A transfer learning approach

Y Gu, H Liu, W Ma - arXiv preprint arXiv:2409.04126, 2024 - arxiv.org
Randomized clinical trials are the gold standard for analyzing treatment effects, but high
costs and ethical concerns can limit recruitment, potentially leading to invalid inferences …

Covariate adjustment and estimation of difference in proportions in randomized clinical trials

J Liu, D Xi - Pharmaceutical Statistics, 2024 - Wiley Online Library
Difference in proportions is frequently used to measure treatment effect for binary outcomes
in randomized clinical trials. The estimation of difference in proportions can be assisted by …