*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued an ICH Harmonized Guideline: ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis. The US Food and Drug Administration adopted this as guidance in May 2021. The ICH E9 (R1) Addendum introduces the estimand framework for clinical trials to obtain relevant and interpretable treatment effects, which enable clear assessment of benefits and risks of treatments. The estimand framework is intended to facilitate the dialogue on drug/biologic development among review disciplines, as well as between sponsors and regulators. This course introduces the estimand framework to statisticians, provides tools to specify clinical questions of interest precisely and facilitate cross-disciplinary collaboration, and highlights key concepts with illustrative examples. Multiple opportunities for questions are included throughout the course as well as an interactive practice session for the audience.