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The Draft ICH E9 (R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” proposes a structured framework that includes the specification of an estimand (“treatment effect to be estimated”), method of estimation (estimator) in the presence of informative and treatment-related events that occur after randomization, and sensitivity analysis to explore the robustness of inferences from the main estimator to deviations from its underlying assumptions.
We will discuss this proposed structured framework and address some key questions: ? How to introduce the estimand into clinical trial planning? ? What attributes are needed to describe an estimand? ? Which strategies are available to frame a scientific question to address intercurrent events? ? How to construct an estimand for a given trial objective? and will exchange experience in framework implementation in practice.
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