This short course will introduce the estimand framework, provide tools to specify clinical questions of interest precisely and to facilitate cross-disciplinary collaboration, and highlights key concepts with illustrative examples. 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.
*Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory.
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