体外诊断试剂真实世界研究的进展与思考

Real-World Research on In Vitro Diagnostics: Progress and Considerations

真实世界证据用于支持药品和医疗器械临床评价与监管决策日益受到重视,国内外均有药品和医疗器械基于真实世界证据获批上市。国内外监管机构陆续发布了多个真实世界研究相关的指导原则,对真实世界数据的研究加以引导和规范。体外诊断试剂作为一类特殊的医疗器械,其临床研究的特点和需求与一般医疗器械有所差异。关于真实世界研究与证据在体外诊断试剂临床研究领域应用的价值和难点,尚缺少系统性的论述。本文通过介绍体外诊断试剂临床研究的特点,美国食品药品监督管理局基于真实世界证据批准体外诊断试剂上市的案例,以及探讨真实世界研究用于体外诊断试剂临床评价的条件、研究设计和获益,提出关于体外诊断试剂真实世界研究的思考和建议。

Real-world evidence is used to support clinical evaluation and regulatory decision-making for drug and medical devices.Drug and medical devices have been approved for marketing both at home and abroad based on real-world evidence.Domestic and foreign regulators have successively issued a number of guidelines to guide and standardize real-world research.As a special class of medical devices,in vitro diagnostics differ in the characteristics and needs of clinical research from general medical devices.There has been little systematic discussion on the values and difficulties of applying real-world research and evidence to the clinical research of in vitro diagnostics.This paper puts forward considerations and suggestions on real-world research of in vitro diagnostics by introducing the characteristics of clinical research on in vitro diagnostics,presenting case study of the U.S.FDA’s approval of in vitro diagnostics based on real-world evidence,and exploring the conditions,research design and benefits of real-world research for clinical evaluation of in vitro diagnostics.