Estimands in Clinical Trials A Practical Guide

Jiawei Wei is Senior Director Biostatistician in the Advanced Methodology and Data Science group at Novartis. She brings extensive expertise in the design, planning, and analysis of clinical trials and is an active contributor to multiple estimand working groups. Her main research interests include estimands, missing data, as well as recurrent event data.

Leslie Meng is a Clinical Data Science Chapter Head in Global Biostatistics and Data Sciences at Boehringer Ingelheim. She is an experienced biostatistician in drug development across various therapeutic areas. Her primary research interests focus on estimands and multiple testing methodologies in clinical research.

Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He served as a member of the ICH E9(R1) Expert Working Group on Estimands and Sensitivity Analysis in Clinical Trials .

Feng Chen is a professor in the Department of Biostatistics at the School of Public Health, Nanjing Medical University. His primary research interests include clinical trial statistics and regulatory science, theoretical and methodological developments in high-dimensional biological data, and the analysis of dependent data. He serves as the chairperson of the China Clinical Trial Statistics (CCTS) Working Group and has been a statistical consulting expert for the National Medical Products Administration (NMPA) of China.

Jun Wang works at the Center for Drug Evaluation (CDE), part of the National Medical Products Administration (NMPA). He leads and contributes to the development of regulatory guidance in biostatistics and actively promotes the application of innovative trial designs in China. He served as a member of the ICH E9(R1) Expert Working Group on Estimands and Sensitivity Analysis in Clinical Trials .