| 姚明宏,贾玉龙,任燕,刘艳梅,邹康,林凯,朱宁,孙鑫.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[J].Chinese journal of Epidemiology,2021,42(7):1306-1311 |
| 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 |
| Real-world data studies of medical products in the context of special healthcare policy: study designs and key considerations |
| Received:February 01, 2021 |
| DOI：10.3760/cma.j.cn112338-20210201-00085 |
| KeyWord: 真实世界数据研究 设计类型 监管决策 博鳌乐城 |
| English Key Word: Real-world data study Study design Regulatory decision making Boao Lecheng |
| FundProject:国家重点研发计划（2019YFC1709804，2017YFC1700406）；四川省青年科技创新研究团队（2020JDTD0015）；四川大学华西医院学科卓越发展1·3·5工程项目（ZYYC08003） |
| Author Name | Affiliation | E-mail | | Yao Minghong | Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
Key Laboratory for Real World Data Research and Evaluation in Hainan/Real World Data Research Institute of Hainan/Real World Data Research and Innovation Center of Boao Lecheng, Qionghai 571435, China | | | Jia Yulong | Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
Key Laboratory for Real World Data Research and Evaluation in Hainan/Real World Data Research Institute of Hainan/Real World Data Research and Innovation Center of Boao Lecheng, Qionghai 571435, China | | | Ren Yan | Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
Key Laboratory for Real World Data Research and Evaluation in Hainan/Real World Data Research Institute of Hainan/Real World Data Research and Innovation Center of Boao Lecheng, Qionghai 571435, China | | | Liu Yanmei | Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
Key Laboratory for Real World Data Research and Evaluation in Hainan/Real World Data Research Institute of Hainan/Real World Data Research and Innovation Center of Boao Lecheng, Qionghai 571435, China | | | Zou Kang | Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
Key Laboratory for Real World Data Research and Evaluation in Hainan/Real World Data Research Institute of Hainan/Real World Data Research and Innovation Center of Boao Lecheng, Qionghai 571435, China | | | Lin Kai | Center for Adverse Drug Reaction Monitoring of Boao Pilot Zone, Qionghai 571435, China
National Medical Produets Administration, Haikou 570216, China | | | Zhu Ning | National Medical Produets Administration, Haikou 570216, China | jflhh@163.com | | Sun Xin | Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
Key Laboratory for Real World Data Research and Evaluation in Hainan/Real World Data Research Institute of Hainan/Real World Data Research and Innovation Center of Boao Lecheng, Qionghai 571435, China | sunx79@hotmail.com |
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| Abstract: |
| 博鳌乐城国际医疗旅游先行区是全国唯一的真实世界数据应用试点地区，基于博鳌乐城特许医疗政策，开展真实世界数据研究，形成支持创新药械临床评价和审评审批的真实世界证据，已成为我国药品审评审批制度改革的重要领域，真实世界证据的产生不仅依靠高质量的真实世界数据，还需要合理可靠的研究设计。本文在国内外相关学术研究和监管部门所发布的真实世界数据研究指导原则或规范的基础上，结合博鳌乐城特殊政策环境和前期实践经验，总结了博鳌乐城真实世界数据研究的设计类型，并探讨了各设计类型在博鳌乐城特殊医疗政策环境中的关键考虑，旨在为进一步实施和开展真实世界数据研究提供借鉴。 |
| English 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. |
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