海南博鳌乐城国际医疗旅游先行区医疗器械真实世界研究初探

Preliminary Research on Medical Device Real-World Study in Hainan Boao Lecheng International Medical Tourism Pilot Zone

本文结合笔者参与海南博鳌乐城国际医疗旅游先行区医疗器械真实世界研究的实践,基于真实世界研究支持产品注册的背景,从监管、伦理审查与免除知情同意、研究设计等角度展开思考,并参考美国国家心血管数据注册登记(NCDR)注册研究的实例,为开发真实世界数据平台提出建议。

Based on our experience in medical device real-world study in the Hainan Boao Lecheng International Medical Tourism Pilot Zone with the aim to support product registration in China,we provide a discussion of current status of real-world study from the perspective of regulation,ethical review and study design.By referencing the real case of U.S.National Cardiovascular Data Registry(NCDR),we provide suggestions for developing the real-world data platform.