Real-World Evidence: Principles and Practice is the definitive introductory text for anyone working with healthcare data to generate evidence. It bridges the gap between theoretical epidemiology and the practical, messy, fast-moving world of real-world studies — providing a structured, accessible, and authoritative guide to the entire RWE landscape.
The book opens with the foundational question: what distinguishes real-world evidence from other forms of scientific evidence, and why does it matter? It traces the full RWE ecosystem — from data sources and stakeholders to study design, statistical concepts, and the institutional contexts in which RWE is generated and used.
The second part moves into practical methodology — covering observational study designs, the management of bias and confounding, and essential statistical concepts, culminating in a practical guide to critically appraising RWE studies. The third part situates RWE in the real world of decision-making: regulatory submissions to the FDA, EMA, and MHRA; clinical and operational decision-making in hospitals and integrated care; pharmaceutical development, safety, market access, and HEOR; digital health and wearables; and the future of AI-driven evidence generation.
Written with clarity and precision, this book requires no prior epidemiological training. It is equally valuable as a first introduction for clinicians, health economists, and data scientists entering the RWE field, and as a structured review for experienced practitioners seeking a comprehensive reference.
