Real-world evidence in medical product development [Documento eletrónico] ; edited by Weili He, Yixin Fang, Hongwei Wang
Language: eng.Country: Switzerland, Swiss Confederation, Cham.Publication: Cham : Springer International Publishing, cop. 2023Description: XXVII, 417 p. : il.ISBN: 978-3-031-26328-6.Subject - Topical Name: Statistics | Artificial intelligence -- Data processing | Computer science -- Mathematics Online Resources:Click here to access onlineItem type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | |
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E-Books | Biblioteca NOVA FCT Online | Não Ficção | QA276.SPR FCT (Browse shelf(Opens below)) | 1 | Available | 96093 |
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.
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