The FDA recently published revised guidance on statistical methods for adjusting for baseline covariates in trials. Overall I like the guidance and think it will prove useful. In this post I’ll give a few thoughts on aspects of the revised guidance, organised according to the sections of the guidance document.
Estimands
These posts are on the topic of ‘estimands’ in clinical trials. The estimand defines how the treatment effect is quantified in the presence of so called intercurrent events in clinical trials. These are events which affect the existence or interpretation of patient outcomes after they occur.