构建博鳌乐城创新药械真实世界数据研究体系:基于我国首个使用境内真实世界数据获批上市的医疗器械研究的探讨

Exploration and practice of real-world data studies on innovative medical products in Boao Lecheng:analysis based on Chinese first case of approved medical device using domestic real-world data

2019年,国家出台《支持建设博鳌乐城国际医疗旅游先行区的实施方案》,允许将国外已上市、临床急需的创新药械作为特许医疗产品在博鳌乐城医疗机构使用;在其实际使用过程中产生的真实世界数据,可采用科学严谨的方法转化为证据用于药械监管决策。2020年3月,我国首个使用境内真实世界数据的医疗器械产品获批上市,表明博鳌乐城真实世界数据应用已取得了初步成功,为促进我国基于真实世界证据支持医疗器械监管的实践提供了重要经验。为此,本文对我国首个使用境内真实世界数据获批上市的医疗器械研究进行总结分析,探讨博鳌乐城创新药械真实世界数据研究体系建设相关问题,旨在为未来的研究提供参考。

In 2019,the national government issued the document"Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Area",which allowed the use of innovative drugs and medical devices in medical institution of Boao Lecheng.These medical products had been designed to meet urgent clinical requirements and had been approved by regulatory authorities overseas.Through the use of these medical products,real-world data were generated in the routine clinical practice,based on which real-world evidence might be produced for regulatory decision-making by using scientific and rigorous methods.In March 2020,the first medical device product using domestic real-world data was approved,suggesting that the real-world data initiative in Boao Lecheng achieved initial success.This work also provided important experience for promoting the practice of medical device regulatory decision-making based on real-world evidence in China.Here,we shared the preliminary experiences from the study on the first approved medical device product and discussed the issues on developing a real-world data research framework in Boao Lecheng in attempt to offer insights for future studies.