UM  > Institute of Chinese Medical Sciences
Status已發表Published
Integrating real-world evidence in the regulatory decision-making process: a systematic documentary analysis of experiences in the US, EU and China using a logic model
Li, M.; Chen, S.; Lai, Y.; Liang, Z.; Wang, J.; Shi, J.; Lin, H.; Yao, D.; Hu, H.; Ung, O. L. C.
2021-05-31
Source PublicationFrontiers in Medicine
ISSN2296-858X
Pages1-16
AbstractReal 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.
Keywordregulatory science real-world evidence decision-making logic model regulation
URLView the original
Language英語English
The Source to ArticlePB_Publication
PUB ID57732
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Corresponding AuthorHu, H.; Ung, O. L. C.
Recommended Citation
GB/T 7714
Li, M.,Chen, S.,Lai, Y.,et al. Integrating real-world evidence in the regulatory decision-making process: a systematic documentary analysis of experiences in the US, EU and China using a logic model[J]. Frontiers in Medicine,2021:1-16.
APA Li, M.,Chen, S.,Lai, Y.,Liang, Z.,Wang, J.,Shi, J.,Lin, H.,Yao, D.,Hu, H.,&Ung, O. L. C..(2021).Integrating real-world evidence in the regulatory decision-making process: a systematic documentary analysis of experiences in the US, EU and China using a logic model.Frontiers in Medicine,1-16.
MLA Li, M.,et al."Integrating real-world evidence in the regulatory decision-making process: a systematic documentary analysis of experiences in the US, EU and China using a logic model".Frontiers in Medicine (2021):1-16.
Files in This Item:
There are no files associated with this item.
Related Services
Recommend this item
Bookmark
Usage statistics
Export to Endnote
Google Scholar
Similar articles in Google Scholar
[Li, M.]'s Articles
[Chen, S.]'s Articles
[Lai, Y.]'s Articles
Baidu academic
Similar articles in Baidu academic
[Li, M.]'s Articles
[Chen, S.]'s Articles
[Lai, Y.]'s Articles
Bing Scholar
Similar articles in Bing Scholar
[Li, M.]'s Articles
[Chen, S.]'s Articles
[Lai, Y.]'s Articles
Terms of Use
No data!
Social Bookmark/Share
All comments (0)
No comment.
 

Items in the repository are protected by copyright, with all rights reserved, unless otherwise indicated.