ABSTRACT

Detailed discussion of estimands is relatively new to clinical trial literature, but very important. Estimands bridge the gap between study objectives and statistical methods (Phillips et al. 2016). The importance of estimands was highlighted in the National Research Council’s (NRC) expert panel report that was commissioned by the Food and Drug Administration (FDA) (NRC 2010). Although the report focused on the problem of missing data, their recommendations set forth an overarching framework for the analysis of longitudinal clinical trial data.