Keywords: Missing data, estimands, sensitivity
The proposed study development framework anticipated to be included in the updated ICH E9 guidance on estimands and sensitivity analyses includes steps for choosing objectives, estimands, design, analysis, and sensitivity. This framework has already had an impact on practice. In this presentation we will examine how clinical trial practice is changing in regard to each step of the study development process chart, we will also examine how interactions between each step is also changing practice. Focus will include trials intended to support regulatory and HTA interactions.