使用真实世界证据支持全球医疗器械监管决策现状

Use of Real-World Evidence to Support Global Regulatory Decision-Making for Medical Devices

医疗器械的监管审批传统上主要依赖于被称为临床研究金标准的随机对照试验(RCT)。快速发展的真实世界数据(RWD)和真实世界证据(RWE)领域在以数据为驱动的创新方面为监管机构和医疗行业带来了巨大的希望。在适当的条件下,充分利用高质量的RWD,作为RCT数据的补充,可以实现更高效地医疗器械开发,并优化产品全生命周期的监管决策。然而,在全世界范围内,监管部门对于RWD/RWE的可接受性和适用性仍然存在差异。本文回顾了RWD和RWE的现有全球指南,并总结了美国系统性地使用RWE支持医疗器械监管决策的宏观政策要素和相关考虑因素。

Traditionally,regulatory approval for medical products has predominately relied on randomized controlled trial(RCT),the gold standard for clinical research.The fast-evolving field of real-world data(RWD)and real-world evidence(RWE)holds great promise in data-driven innovation for both regulatory authorities and industry.Under the right conditions,unleashing the power of high-quality RWD,as a complement to RCT-derived data,enables more efficient medical device development and streamlines regulatory decision-making across the product life cycle.However,there remains a gap in the acceptability and applicability of RWD/RWE for regulatory use worldwide.The current report reviews the existing global guidance on RWD and RWE and summarizes the principal elements and considerations associated with the systematic use of RWE in support of regulatory decision-making for medical devices in the United States(U.S.).