中国实时基于风险的临床试验质量管理:开发数字监测平台
Min Jiang1, Shuhua Zhao2, Yun Mei3
1State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, 52 Fucheng Rd, Haidian District, Beijing, China, 86 01088196664.
JMIR medical informatics
|April 25, 2025
概括
一个新的数字平台使用大数据和人工智能来监测中国的临床试验质量,减少错误并提高准确性. 这种自动化系统可以实时检测风险,提高药物评估的效率和患者安全.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 数据科学数据科学数据科学
背景情况:
- 中国传统的临床试验质量管理依赖于手动监测,导致效率低下和潜在的错误.
- 对于在中国医院管理临床试验质量的先进,准确的系统有着至关重要的需求.
- 提高临床试验质量监测的效率和准确性对于药物评估至关重要.
研究的目的:
- 开发一个用于实时监控临床试验的数字平台.
- 在整个临床试验生命周期中检测和警告风险点.
- 将平台建立在历史临床试验质量控制结果的基础上.
主要方法:
- 开发了一个使用大数据分析和自动定量技术的数字动态监控平台.
- 利用历史临床试验质量控制 (QC) 报告 (2019-2023) 进行培训和验证.
- 采用自然语言处理 (NLP) 来自动分析QC报告文本和对风险评估进行层次分类.
主要成果:
- 根据1380份QC报告 (2019-2022) 建立了189个警告值.
- 对211个质量控制报告 (2023) 应用值,其中19.9%引发警告.
- 在培训数据和2023年报告之间观察到QC发现的一致模式.
结论:
- 数字工具可以在所有临床试验阶段实现自动,实时的风险检测.
- 它准确地确定了关键试验程序和需要注意的功能.
- 该平台有助于质量管理人员迅速采取行动,防止出现反复出现的问题.
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