开发CDISC儿科用户指南:CDISC和connect4children的合作
John Owen1, Anando Sen2, Beate Aurich3
1CDISC Europe Foundation, Brussels, Belgium.
Frontiers in medicine
|July 5, 2024
概括
儿科用户指南 (PUG) 增强了对儿童临床试验数据的标准化. 本指南由connect4children (c4c) 和CDISC共同开发,旨在解决儿童特异性标准的缺乏问题,改善儿科研究中的数据互操作性和重用.
科学领域:
- 临床试验 临床试验
- 数据标准化数据标准化
- 儿科研究 儿科研究
背景情况:
- 儿科临床试验在数据标准化和重复使用方面面临挑战.
- 现有的临床数据交换标准联盟 (CDISC) 标准缺乏儿科特异性.
- 学术机构对CDISC标准的认识有限,阻碍了数据互操作性.
研究的目的:
- 为儿童临床试验数据制定标准化指南.
- 为了解决缺乏针对儿童的CDISC标准的问题.
- 促进数据的重复使用和儿科研究中的互操作性.
主要方法:
- 在Connect4Children (c4c) 和CDISC之间开展合作.
- 通过六个阶段开发儿科用户指南 (PUG).
- 包括在儿科试验中例行收集的横断数据项.
主要成果:
- 该PUG于2023年2月23日在CDISC网站上发表.
- 该指南包含了与所有儿科年龄段相关的概念.
- 纳入了CDISC内部和公共审查的反.
结论:
- PUG是朝着儿童特定的CDISC标准迈出的关键一步,特别是在学术界.
- 广泛采用PUG将使多个儿科试验的数据聚合成为可能.
- 这有助于研究罕见儿科疾病和小患者群体.
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