【摘要】 本文旨在为我国制定合适标准来评估真实世界数据(RWD)适应性,助力医疗器械审批和监管决策相关制度建立提供参考。通过深入剖析美国FDA《使用真实世界证据支持医疗器械的监管决策指南》中对RWD适用性评估的系列要素,寻求评估RWD适应性,使RWD转化为真实可用的真实世界证据(RWE)的相关标准。我国RWD适应性评估可以从相关性和可靠性2个层面进行,RWD相关性评估可从数据来源及选取范围、数据有效性、监管要求、伦理问题和可操作性5个方面设计评估标准。在RWD可靠性方面可从管理流程规范性、数据标准化、数据质量控制三方面设计评估标准。更多还原

【Abstract】 This paper is expected to provide reference for China to establish appropriate standards to evaluate the adaptability of real-world data, and facilitate the establishment of related systems for medical device approval and supervision. Finding appraised standard to evaluate the suitability of real-world data by analyzing the series of factors in the "Use of Real-world Evidence to Support Regulatory Decision-Making for Medical Devices", in order to turn real-world data(RWD) into a truly practical real-word evidence(RWE). The adaptability assessment of China’s RWD can be carried out from 2 aspects such as relevance and reliability. In the aspect of RWD relevance assessment, evaluation criteria can be designed from 5 aspects: data source and selection, data validity, regulatory requirements, ethical issues as well as operability. In the aspect of real world data reliability assessment, evaluation criteria can be designed from 3 aspects: management process standardization, data standardization and quality control.更多还原