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 …

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 …

Adjustment for baseline covariates in randomized trials has been shown to lead to gains in
power and can protect against chance imbalances in covariates. For continuous covariates …

Recent years have seen an increasing interest in incorporating external control data for
designing and evaluating randomized clinical trials (RCT). This may decrease costs and …

We are grateful for the opportunity to respond to the compelling, albeit strongly worded
critique from Professor Harrell (referred to as Harrell from here on). We are disappointed that …

Pam Shaw: It is my great pleasure to introduce our discussant panelists. I'll start with Dr.
Mark Rothmann, who is the Director of the US Food and Drug Administration (FDA) Division …

In this work, we proposed a novel inferential procedure assisted by machine learning based
adjustment for randomized control trials. The method was developed under the …