Does This Treatment Cause That Outcome?: The Science of Estimating a Treatment Effect and Why It Matters (Chapman & Hall/CRC Biostatistics Series)

This book is an engaging and insightful exploration of cause-and-effect relationships in clinical research.It begins with the foundational principles of causal inference, traces the historical evolution of randomized controlled trials, and provides a clear, comprehensive explanation of the essential elements of ICH E9(R1).The central themes of ICH E9(R1) - defining the clinical question of primary importance and establishing the estimand to answer that question - are seamlessly integrated throughout the narrative. A standout feature is the introduction of the Tripartite Estimand Approach, a groundbreaking framework derived from patient and physician perspectives.This approach addresses the critical questions and answers needed for informed prescribing decisions.The book also outlines a stepwise, logical process for implementing the estimand framework, offering practical guidance for clinicians, statisticians, and other professionals involved in clinical drug development.By simplifying