Additional information
by Massoud Toussi (Author)
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 trials
- Real-world data source types, digital health, and emerging technologies
- Study lifecycle, observational designs, bias, and essential statistical concepts
- Critical appraisal and interpretation of real-world studies
- Regulatory use of RWE across FDA, EMA, MHRA, and global agencies
- RWE use in health technology assessment accross EU JCA, NICE, HAS, and other HTA bodies
- Applications in hospitals, integrated care, quality improvement, and life sciences
- Real-world evidence strategy planning and integrated evidence generation
- AI, real-world trials, and the future of learning health systems
Real-World Evidence: Principles and Practice is an essential resource for anyone seeking to understand, generate, or apply real-world evidence with confidence and sophistication.
