ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

On 18 February 2020 the EMA published the Step 5 on ICH E9 (R1) addendum on estimands and sensitivity in clinical trials.

This addendum presents a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis and interpretation, as well as between sponsor and regulator regarding the treatment effect(s) of interest that a clinical trial should address.

The principles outlined in this addendum are relevant whenever a treatment effect is estimated, or a hypothesis related to a treatment effect is tested, whether related to efficacy or safety. While the main focus is on randomised clinical trials, the principles are also applicable for single arm trials and observational studies. The framework applies to any data type, including longitudinal, time-to-first event, and recurrent event data. Regulatory interest in the application of the principles outlined will be greater for confirmatory clinical trials and, where used to generate confirmatory conclusions, for data integrated across trials.

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