Yao M H, Jia Y L, Ren Y, Liu Y M, Zou K, Lin K, Zhu N, Sun X
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.
Center for Adverse Drug Reaction Monitoring of Boao Pilot Zone，Qionghai 571435，China National Medical Produets Administration，Haikou 570216，China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Jul 10;42(7):1306-1311. doi: 10.3760/cma.j.cn112338-20210201-00085.
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.
博鳌乐城国际医疗旅游先行区是中国唯一开展真实世界数据试点应用的行政区。基于博鳌乐城特殊的医疗政策，开展真实世界数据研究，为创新医疗产品的临床评价和审批提供真实世界证据，已成为支撑中国医疗产品审评审批制度改革的重要领域。可靠的真实世界证据既需要高质量的真实世界数据，也需要合理严谨的研究设计。本文依据国内外相关学术研究和监管机构发布的真实世界数据研究指南与规范，结合博鳌乐城的特殊政策环境和既往实践经验，总结了博鳌乐城真实世界数据的研究设计，并探讨了在博鳌乐城特殊医疗政策背景下不同研究设计的关键考量因素，以期为真实世界数据的进一步研究提供参考。
