Statistics and Data Science Seminar
Jane Qian
Abbvie
Overview of ICH E9(R1): Estimands and Sensitivity Analysis in Clinical Trials
Abstract: ICH is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. ICH E9 guideline (“Statistical Principles for Clinical Trials”) was published in 1995 and has since served as a foundation of regulatory guidance on major statistical aspects of confirmatory clinical trials. In October 2014, the Steering Committee of ICH endorsed the formation of an expert working group to develop an addendum to the ICH E9 guideline. In 2017, the addendum ICH E9(R1) (Estimands and sensitivity analyses in clinical trials) was released for public comment. ICH E9(R1) focus on two topics involving randomized confirmatory clinical trials: estimands and sensitivity analyses. Both topics are motivated by the need to improve the precision with which scientific questions of interest are formulated and addressed by clinical researchers and regulators, specifically in the context of post-randomization (intercurrent) events such as use of rescue medication or missing data. In this seminar, an overview of ICH E9(R1) will be given with the focus on why it was necessary to develop this ICH E9 addendum, what it entails and the impact of the addendum on future clinical trial design and analyses.
Wednesday April 10, 2019 at 4:00 PM in 636 SEO