Keywords: estimand, intercurrent event, sensitivity analysis, missing data
The ICH E9(R1) Expert Working Group proposed a new structured framework to align planning and design of clinical trials, their conduct, analysis of the data and interpretation of the results. An estimand defines what needs to be estimated to address a specific scientific question of interest of trial objective. Components of estimands include the population of interest, endpoint of interest, the intervention effect of intercurrent events, and the summary measure. Several strategies for addressing the intercurrent events are considered and some recommendations how to construct an estimand are suggested. In this presentation, an overview of this framework will be provided and its impact on the trial design, conduct, and analysis will be briefly emphasized.