Exploration of construction mode of real-world data system.
10.3760/cma.j.cn112338-20210824-00675
- VernacularTitle:真实世界数据体系构建的模式探索
- Author:
Yan Mei LIU
1
;
Yan REN
2
;
Yu Long JIA
1
;
Ming Hong YAO
1
;
Kang ZOU
1
;
Kai LIN
3
;
Xin SUN
1
Author Information
1. Chinese Evidence-based Medicine Center and Cochrane China Center, West China Hospital, Sichuan University, Chengdu 610041, China.
2. NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu 610041, China.
3. Center for Adverse Drug Reaction Monitoring of Boao Pilot Zone of Hainan province, Haikou 570216, China.
- Publication Type:Journal Article
- From:
Chinese Journal of Epidemiology
2022;43(3):418-423
- CountryChina
- Language:Chinese
-
Abstract:
Real-world data study evidence, as an important part of evaluating the safety and effectiveness of drugs and devices, has attracted increasing attention from regulatory agencies and scholars both at home and abroad, and has become an essential source of evidence to support the development and review of drugs and devices. This paper systematically discusses the process and mode of real-world data system construction based on the preliminary practical study of real-world data according to the guidelines/technical specifications issued by regulatory agencies and academic research results. This study result provides not only reference for the generation of clinical evaluation evidence to meet the regulatory requirements for innovative drugs and devices, but also reference for researchers, sponsors and regulators to carry out real-world data studies successfully.
