Residential College | false |
Status | 已發表Published |
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 Publication | Frontiers in Medicine |
ISSN | 2296-858X |
Volume | 8Pages: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. |
Keyword | Decision-making Logic Model Real-world Evidence Regulation Regulatory Science |
DOI | 10.3389/fmed.2021.669509 |
URL | View the original |
Indexed By | SCIE |
Language | 英語English |
WOS Research Area | General & Internal Medicine |
WOS Subject | Medicine, General & Internal |
WOS ID | WOS:000660994300001 |
Publisher | FRONTIERS MEDIA SAAVENUE DU TRIBUNAL FEDERAL 34, LAUSANNE CH-1015, SWITZERLAND |
Scopus ID | 2-s2.0-85107821101 |
Fulltext Access | |
Citation statistics | |
Document Type | Journal article |
Collection | Institute of Chinese Medical Sciences THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU) |
Corresponding Author | Hu, Hao; Ung, Carolina Oi Lam |
Affiliation | State Key Laboratory in Quality Research of Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao |
First Author Affilication | Institute of Chinese Medical Sciences |
Corresponding Author Affilication | Institute 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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