Overview: A first-of-its-kind, structured end-to-end, comprehensive perspectives from different stakeholders, with real examples.Includes special chapters on estimand, causal inference roadmap, fit-for-purpose .This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incenti
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