We are pleased to announce our Special Presentations.
by Leslie Meng, Director of Biostatistics, Boehringer-Ingelheim
ICH E9(R1) is an addendum on Estimands and Sensitivity Analysis in Clinical Trials to the guideline on Statistical Principles for Clinical Trials (ICH E9). ICH E9(R1) proposed a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis and interpretation, as well as between sponsor and regulator regarding the clinical question of interest that a clinical trial should address. ICH E9(R1) was finalized in Dec 2019, and now it's at step 5 for adoption by each country's health authority. In January 2021, NMPA announced that the adoption of ICH E9(R1) will start in Jan 2022 which means every clinical trial will implement Estimand in the protocol as well as statistical analysis plan. In this talk, the mystery of Estimand will be unveiled, a case sharing will show how the Estimand concept is implemented in the clinical trial and how this impacts on the analyses from statistical programmers' perspective.