Correcting For The Individual Patient Regression To The Mean 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.

Putting Patient Uniqueness at the heart of Innovation

Access to innovative therapies remains an issue. In certain diseases, the magnitude and variability of individuals’ placebo response (IPR) can confound detection of positive results in clinical trials. Despite the best efforts and investments by pharmaceutical industry stakeholders, patients are still waiting for optimal treatments.