Real‑World Evidence: Principles and Practice offers a clear, structured, and comprehensive guide to one of the most influential domains in modern healthcare. It explores how real‑world evidence is conceived, generated, interpreted, and applied across clinical, regulatory, and strategic decision‑making.The book introduces the core principles of RWE, the logic of observational research, and the practical realities of working with real‑world studies. It explains how to recognize bias, interpret results, and critically appraise evidence with confidence. It also examines how regulators, hospitals, integrated care systems, and life‑science organizations rely on RWE to guide decisions that affect patients, products, and policy.From foundational concepts to advanced applications—including digital health, remote monitoring, artificial intelligence, and emerging learning health systems—this book equips professionals with the tools and frameworks needed to navigate an evolving evidence landscape.Recommended by world class academics, regulators and professionals it offers a clear, authoritative resource for healthcare, pharma, regulatory, and HTA leaders seeking to use real‑world evidence with rigor, clarity, and impact.Key topics include:Foundations of RWE and its role alongside randomized trialsReal‑world data source types, digital health, and emerging technologiesStudy lifecycle, observational designs, bias, and essential statistical conceptsCritical appraisal and interpretation of real‑world studiesRegulatory use of RWE across FDA, EMA, MHRA, and global agenciesRWE use in health technology assessment accross EU JCA, NICE, HAS, and other HTA bodiesApplications in hospitals, integrated care, quality improvement, and life sciencesReal-world evidence strategy planning and integrated evidence generationAI, real‑world trials, and the future of learning health systemsReal‑World Evidence: Principles and Practice is an essential resource for anyone seeking to understand, generate, or apply real‑world evidence with confidence and sophistication. Read more ASIN B0H21D5Z63 ISBN13 979-8994823507 Language English Publisher Elixir Institute Dimensions 6 x 0.72 x 9 inches Book 1 of 2 Evidence Mastery Item Weight 15 ounces Print length 318 pages Publication date May 15, 2026