Publications

There is a continuous growth in data collected in clinical trials. Many of those patient’s characteristics are potential confounding factors. Ideally, these factors should be accounted for in the randomization process to balance study arms and reduce the variability of the estimated treatment effect.

Often, the primary endpoint of RCTs is defined as a change from baseline of a continuous outcome. In
such cases, regulators recommend including the outcome’s baseline value as a covariate in the
statistical analysis. Regression to the mean can explain the benefits of this procedure.

The amount of data collected from patients involved in clinical trials is continuously growing. All those patient’s characteristics are potential covariates that could be used to improve study analysis and power. At the same time, the development of computerized systems simplifies the access to huge amount of historical data.