ID - 131909229 TI - Real-World Evidence in Medical Product Development AU - He, Weili AU - Fang, Yixin AU - Wang, Hongwei AU - SpringerLink (Online service) PY - 2023 SN - 9783031263286 9783031263279 9783031263293 9783031263309 PB - Cham Springer International Publishing :Imprint: Springer DB - UniCat KW - Statistical science KW - Computer science KW - Artificial intelligence. Robotics. Simulation. Graphics KW - Computer. Automation KW - informatica KW - statistiek KW - wiskunde KW - KI (kunstmatige intelligentie) UR - https://www.unicat.be/uniCat?func=search&query=sysid:131909229 AB - 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 incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases. ER -