Keywords: Estimands, sensitivity
This presentation will focus on sensitivity analyses and the considerations that lead to them in the context of the ICH E9 R1 addendum. In the more familiar context of sensitivity analyses for missing data, a logical framework with specific and useful statistical methods have been developed and are described. However, the expansion of context in the ICH E9 (R1) addendum from that of a missing data problem to the broader context of dealing with all intercurrent events requires broader thinking on sensitivity analyses. For each of the five strategies for dealing with intercurrent events initial ideas for appropriate sensitivity analyses are presented. However, this is an area where more research is needed.