In this webinar, the EU regulatory and Industry members of the ICH E9(R1) working group will present the new draft addendum for ICH E9 on estimands and sensitivity analysis. The addendum introduces a new framework for designing and analysing clinical trials aligned to the trial objectives.
Rob Hemmings (MHRA) will present the motivation behind the new draft addendum, define estimands and sensitivity analysis, and explain different strategies that can be used in constructing an estimand.
Frank Bretz (Novartis) will present case studies to illustrate how the new framework can be implemented in designing clinical trials and defining the appropriate analysis methods.