真实世界数据体系构建的模式探索

Exploration of construction mode of real-world data system

真实世界数据研究证据作为评价药物和医疗器械(药械)安全性和有效性的重要组成部分,日益受到国内外监管机构和学者的关注,已成为支持药械研发与审评的关键证据来源。本文在真实世界数据的前期实际研究基础上,结合国内外监管机构所发布的指导原则/技术规范和学术研究成果,系统探讨了真实世界数据体系的构建流程和模式探索。以期为特许药械产生满足监管要求的临床评价证据提供参考,而且为研究者、申办方及监管部门顺利开展真实世界数据研究提供借鉴。

Real-world data study evidence,as an important part of evaluating the safety and effectiveness of drugs and devices,has attracted increasing attention from regulatory agencies and scholars both at home and abroad,and has become an essential source of evidence to support the development and review of drugs and devices.This paper systematically discusses the process and mode of real-world data system construction based on the preliminary practical study of real-world data according to the guidelines/technical specifications issued by regulatory agencies and academic research results.This study result provides not only reference for the generation of clinical evaluation evidence to meet the regulatory requirements for innovative drugs and devices,but also reference for researchers,sponsors and regulators to carry out real-world data studies successfully.