Real-world data studies of medical products in the context of special healthcare policy: study designs and key considerations
10.3760/cma.j.cn112338-20210201-00085
- VernacularTitle:特许医疗政策下的药械真实世界数据研究常见设计及其关键考虑
- Author:
Minghong YAO
1
;
Yulong JIA
;
Yan REN
;
Yanmei LIU
;
Kang ZOU
;
Kai LIN
;
Ning ZHU
;
Xin SUN
Author Information
1. 四川大学华西医院中国循证医学中心，成都 610041
- Keywords:
Real-world data study;
Study design;
Regulatory decision making;
Boao Lecheng
- From:
Chinese Journal of Epidemiology
2021;42(7):1306-1311
- CountryChina
- Language:Chinese
-
Abstract:
Boao Lecheng International Medical Tourism Pilot Area is the only administrative area in China where the pilot application of real-world data is performed. Based on the special healthcare policy in Boao Lecheng, conducting real-world data study to provide real-world evidence for the clinical evaluations and approvals of innovated medical products has become an important field that supports the reform of China's evaluation and approval system of medical products. Trustworthy real-world evidence needs to rely on both high-quality real-world data and reasonable and rigorous study designs. Based on the real-world data research guidelines and specifications issued by relevant academic research and regulatory authorities both at home and abroad, combined with the special policy environment of Boao Lecheng and previous practice experience, this paper summarizes the study designs of real world data in Boao Lecheng and discusses the key considerations of different study design in the context of special healthcare policies in Boao Lecheng in order to provide reference for the further study of real-world data.
