2021年10月21日FDA发布了真实世界数据指导原则,题目为Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry。 www.fda.com 指导原则(征求意见稿)的核心内容是 Challenges in Real-World Data StandardizationDocumentation of Processes for Managing Real-World DataConsiderations for Conforming Real-World Data to Currently Supported FDA Study Data StandardsConsiderations for Mapping Real-World Data to Study Data Submission StandardsConsiderations for Data Transformations 说实话大叔没有细看,也看不懂,这里摘录一段Derrick Gingery的评论,了解一二。 标准化真实世界的数据以符合美国食品和药物管理局的要求可能很困难,而新的指南表明,当信息旨在显示安全性或有效性时,劳动密集度较低(less-labor intensive)的解决方
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