Estimands in Clinical Trials – ICH E9 Addendum
11:50 AM - 12:10 PM
In November 2019, the International Council on Harmonization (ICH) released the final version of the addendum (R1) to ICH E9 guidance addressing statistical methods for use in clinical trials based on the notion of estimand. The objective of this guidance was to further elaborate the general framework for translating the objectives of a clinical trial into a corresponding study design, an appropriate conduct, and a robust statistical analysis.
In this lecture, we will review the different aspects and definitions linked to the notion of estimand and illustrate it with real-life examples from the cardiovascular fields.