现代化临床研究数据基础设施以满足不断变化的证据需求
Joseph B Franklin1, Caroline Marra1, Kaleab Z Abebe2
1Verily Life Sciences, South San Francisco, California.
JAMA
|August 5, 2024
概括
临床试验数据基础设施仍然低效,限制了证据的产生. 一个现代化的系统将整合多样化的数据来源,并使数据可用于更好的临床试验结果.
科学领域:
- 临床研究信息学
- 健康数据科学
背景情况:
- 临床试验数据获取,获取和使用系统的演变极小,导致碎片化和低效.
- 目前的临床试验数据基础设施成本高,劳动密集,限制了生成证据的数量和质量.
- 尽管电子健康记录和数据标准化取得了进展,但临床试验数据基础设施缺乏统一的方法.
研究的目的:
- 提出一个现代化的临床试验数据基础设施的愿景.
- 解决临床试验当前数据收集方法的局限性.
- 为了满足随机临床试验的强有力的证据需求.
主要方法:
- 以收集和评估多个数据来源和类型为中心的现代化基础设施的概念化.
- 设想一个系统,使健康数据可用于各种目的.
- 强调基础设施发展需要多学科合作.
主要成果:
- 提出了一个现代化临床试验数据基础设施的框架.
- 拟议的基础设施支持多种数据流的整合.
- 重点是使数据能够在不同的研究和临床应用中重复使用.
结论:
- 现代化临床试验数据基础设施对于增强证据生成至关重要.
- 拟议的愿景有助于对多个数据源进行严格的评估,并促进数据的重复使用.
- 实现这一现代化基础设施的关键是多学科合作和进度测量.
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