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PSI One Day Meeting: Estimands, Sep 2017 Part 1 - Estimands and Sensitivity Analyses: What’s in the new ICH E9 Addendum?

26 September 2017

The new addendum to ICH E9 on estimands and sensitivity analyses introduces a new framework for clinical trial design, conduct, analysis and interpretation of results. In the new framework the first step is to ensure there is a clearly defined clinical trial objective. The trial objective will lead to defining the estimand, the treatment effect to be estimated, which will influence the choice of trial design. The estimand will lead to defining appropriate statistical analyses to derive estimates of treatment effects, including sensitivity analyses that are aligned to the estimand.

The new framework in the ICH E9 addendum will enable sponsors to discuss with regulators prior to the clinical trial commencing what estimand is of primary interest. Choices made in the study design and planned statistical analyses describing how intercurrent events, such as non-adherence, use of rescue medication, and deaths occurring in the study, will be handled can impact what treatment effect is actually being estimated in a clinical trial. Therefore alignment in the choice of estimand and planned statistical analyses, including sensitivity analyses, will improve the interpretation and understanding of trial results.

This presentation will provide an overview of the new addendum including examples illustrating how to use the new framework in designing clinical trials.

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