Real-World Evidence in Medical Product Development

417 Seiten, Taschenbuch

Kurzbeschreibung des Verlags

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.

• Themen: Mathematik und Naturwissenschaften Mathematik Wahrscheinlichkeitsrechnung und Statistik
• ISBN: 9783031263309
• Sprache: Englisch
• Erscheinungsdatum: 12.05.2024
• Größe: 23.5 x 15.5 cm
• Verlag: Springer International Publishing
• Herausgegeben von: Weili He, Yixin Fang, Hongwei Wang