真实世界研究用于医疗器械临床评价的探讨

Discussion on the Application of Real-world Study for Clinical Evaluation of Medical Devices

目的:探究真实世界研究(RWS)如何在遵循伦理和法规的基础上,形成支持医疗器械上市监管决策的真实世界证据。方法:基于国内外关于RWS在医疗器械临床研究的相关政策、指导原则和研究现状,从研究方案设计要点、真实世界数据质量控制、数据统计分析以及实例分析等方面,分析RWS在医疗器械临床评价中的要求。结果与结论:RWS因其宽松的患者入组标准、广泛的覆盖人群以及庞大的样本量等特点,为医疗器械上市提供了有力的支持。科学、合理地设计临床试验方案,确保临床试验实施过程的可追溯性和质量可控,合理运用统计分析方法,是将真实世界数据转化为真实世界证据的关键。推动RWS在医疗器械临床试验中的应用,将加快医疗器械上市,促进整个医疗器械行业的健康快速发展。

Objective:To explore how real-world study(RWS)generate real-world evidence to support regulatory decisions for the marketing of medical devices based on ethical and regulatory compliance.Methods:Based on the relevant policies,guiding principles,and research status of RWS in clinical research of medical devices both domestically and internationally,the requirements of RWS in clinical evaluation of medical devices were analyzed from the aspects of key points of research scheme design,real-world data quality control,data statistical analysis and case analysis.Results and Conclusion:RWS provides strong support for the marketing of medical devices due to its relaxed patient enrollment criteria,broad population coverage,and large sample size.The scientifi c and logical design of clinical trial program,the traceability and quality control throughout the implementation process,as well as the appropriate use of statistical analysis methods are the key for transforming real-world data into real-world evidence.Promoting the application of RWS in medical device clinical trials will facilitate the marketing of medical devices and promote the healthy and rapid development of the entire medical device industry.