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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
Li, Meng; Chen, Shengqi; Lai, Yunfeng; Liang, Zuanji; Wang, Jiaqi; Shi, Junnan; Lin, Haojie; Yao, Dongning; Hu, Hao; Ung, Carolina Oi Lam
2021-05-31
Source PublicationFrontiers in Medicine
ISSN2296-858X
Volume8Pages:669509
Abstract

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 systematic documentary analysis about how RWE was integrated for the use by the DRAs in evaluating new treatment approaches and monitoring post-market safety. This study aimed to analyze and discuss the integration of RWE into regulatory decision-making process from the perspective of DRAs. Different development strategies to develop and adopt RWE by the DRAs in the US, Europe, and China were reviewed and compared, and the challenges encountered were discussed. It was found that different strategies on development of RWE were applied by FDA, EMA, and NMPA. The extent to which RWE was adopted in China was relatively limited compared to that in the US and EU, which was highly related to the national pharmaceutical environment and development stages. A better understanding of the overall goals, inputs, activities, outputs, and outcomes in developing RWE will help inform actions to harness RWD and leverage RWE for better health care decisions.

KeywordDecision-making Logic Model Real-world Evidence Regulation Regulatory Science
DOI10.3389/fmed.2021.669509
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaGeneral & Internal Medicine
WOS SubjectMedicine, General & Internal
WOS IDWOS:000660994300001
PublisherFRONTIERS MEDIA SAAVENUE DU TRIBUNAL FEDERAL 34, LAUSANNE CH-1015, SWITZERLAND
Scopus ID2-s2.0-85107821101
Fulltext Access
Citation statistics
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU)
Corresponding AuthorHu, Hao; Ung, Carolina Oi Lam
AffiliationState Key Laboratory in Quality Research of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
Li, Meng,Chen, Shengqi,Lai, Yunfeng,et al. 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[J]. Frontiers in Medicine, 2021, 8, 669509.
APA Li, Meng., Chen, Shengqi., Lai, Yunfeng., Liang, Zuanji., Wang, Jiaqi., Shi, Junnan., Lin, Haojie., Yao, Dongning., Hu, Hao., & Ung, Carolina Oi Lam (2021). 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. Frontiers in Medicine, 8, 669509.
MLA Li, Meng,et al."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".Frontiers in Medicine 8(2021):669509.
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