在学术早期临床试验中患者报告的电子不良事件监测:可行性研究
Leanne Shearsmith1, Sarah Danson2,3, Sarah Gelcich1
1Patient Reported Outcomes Group, Section of Patient-Centred Outcomes Research, Leeds Institute of Medical Research (LIMR) at St James's, University of Leeds, Leeds, UK.
Clinical trials (London, England)
|October 27, 2025
概括
电子患者报告的不良事件对于早期临床试验中的瘤病患者来说是可行的和可以接受的. 这种方法捕获的症状比临床医生记录的事件更多,增强了安全监测.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者安全 患者安全
- 数字健康数字健康
背景情况:
- 副作用监测对于早期瘤学临床试验中的患者安全至关重要.
- 电子患者报告不良事件 (ePRAE) 系统为传统的临床医生主导的记录提供了一种可行和补充的方法.
- 开发了一种新的ePRAE系统,并在早期试验阶段的患者中进行了测试.
研究的目的:
- 评估远程电子患者报告不良事件系统的可行性和可接受性.
- 评估ePRAE系统的合规性,招聘和退出率.
- 为了比较ePRAE记录的不良事件的覆盖率与临床医生记录的数据.
主要方法:
- 在两个医院进行了前性单臂可行性研究.
- 成年瘤学患者开始新型抗癌疗法在早期阶段的试验与互联网接入被录取.
- 参与者在12周内每周填写远程ePRAE问卷,主要结果是合规性.
主要成果:
- 23名参与者同意 (76.7%的同意率),其中18人完成了为期12周的研究.
- 观察到每周ePRAE问卷的高度遵守 (85.1%).
- ePRAE捕获的症状数量是临床记录 (n=50) 的三倍 (n=174),这表明不良事件覆盖范围更广泛.
结论:
- 对于早期瘤学试验中的患者来说,远程ePRAE报告是可行的和可以接受的.
- 与传统方法相比,ePRAE系统显著提高了不良事件的捕获.
- 后勤考虑对于未来的ePRAE实施至关重要,以确保全面记录不良事件.
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