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Real-World Evidence in Medical Product Development

Authors :
Weili He
Yixin Fang
Hongwei Wang
Weili He
Yixin Fang
Hongwei Wang
Publication Year :
2023

Abstract

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.

Subjects

Subjects :
Clinical trials
Drug development

Details

Language :
English
ISBNs :
9783031263279 and 9783031263286
Database :
eBook Index
Journal :
Real-World Evidence in Medical Product Development
Publication Type :
eBook
Accession number :
3612468