利用真实世界数据推进儿童传染病的循证治疗：机遇与挑战。
Advancing evidence-based treatment of infectious diseases in children with real-world data: Opportunities and challenges.
作者信息
Radtke Kendra K, Butte Atul J
机构信息
Bakar Computational Health Science Institute, University of California, San Francisco, San Francisco, CA, United States.
Department of Pediatrics, University of California, San Francisco, San Francisco, CA, United States.
出版信息
Front Pharmacol. 2023 Jan 12;13:1054688. doi: 10.3389/fphar.2022.1054688. eCollection 2022.
There is an increased interest in utilizing real-world data (RWD) for pharmaceutical research and regulatory decision-making. The development and use of pediatric medicines could benefit greatly from real-world data studies given nearly half of drugs prescribed to children are "off-label", meaning there is a lack of pediatric-specific evidence from controlled trials, while there is an abundance of data from routine clinical practice. Currently, the use of real-world data, such as data from electronic health records, is lacking in pediatric research, especially within infectious diseases. Here, we discuss opportunities and challenges for real-world data to generate evidence on the optimal treatment and management of infectious diseases in children.
利用真实世界数据（RWD）进行药物研究和监管决策越来越受到关注。鉴于近一半给儿童开的药都是“超说明书用药”，即缺乏来自对照试验的儿科特异性证据，而常规临床实践中有大量数据，儿科药物的开发和使用可以从真实世界数据研究中大大受益。目前，儿科研究中缺乏对真实世界数据的使用，如电子健康记录中的数据，尤其是在传染病领域。在此，我们讨论利用真实世界数据为儿童传染病的最佳治疗和管理提供证据的机遇与挑战。
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