Estimands in Clinical Trials A Practical Guide [#1009207]

Free Download Estimands in Clinical Trials: A Practical Guide
English | 2026 | ISBN: 303202191X | 483 Pages | PDF EPUB (True) | 10 MB
This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interest-and by carefully accounting for intercurrent events-the framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.