Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little syste...

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Vydáno v:Front Med (Lausanne)
Hlavní autoři: Li, Meng, Chen, Shengqi, Lai, Yunfeng, Liang, Zuanji, Wang, Jiaqi, Shi, Junnan, Lin, Haojie, Yao, Dongning, Hu, Hao, Ung, Carolina Oi Lam
Médium: Artigo
Jazyk:Inglês
Vydáno: Frontiers Media S.A. 2021
Témata:
Medicine
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC8200400/
https://ncbi.nlm.nih.gov/pubmed/34136505
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fmed.2021.669509
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