量化站点负担以优化协议性能
Maria Florez1, Zachary Smith2, Zachary Olah3
1Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, USA. maria.florez@tufts.edu.
Therapeutic innovation & regulatory science
|January 9, 2024
概括
分散临床试验 (DCT) 可能会增加站点负担,一半的受访站点发现它们比传统试验更负担. 远程操作任务的负担较小,但在DCT中面向患者的临床程序更为繁重.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 药物开发 药物开发
背景情况:
- 协议的复杂性增加了调查现场的工作量.
- 目前对现场负荷的测量是不完整的.
- 分散临床试验 (DCT) 对现场负担的影响没有系统测量.
研究的目的:
- 与传统的临床试验相比,评估分散的临床试验 (DCT) 的负担.
- 评估DCT对临床研究现场人员的影响.
主要方法:
- 在全球临床研究网站中进行了一项在线调查.
- 收集了355个回复,评估不同试验活动的现场负担.
- 评估了传统和分散的方法.
主要成果:
- 超过50%的网站没有使用DCT解决方案的经验;只有6.6%的网站进行了完全分散的试验.
- 一半的受访者认为DCT解决方案比传统试验更加繁重.
- 远程操作/管理任务的负担较小,而面向患者的临床程序在DCT中更为繁重.
结论:
- DCT对现场负担产生了不同的影响.
- 远程执行有利于操作方面,但在患者互动程序中存在挑战.
- 需要进一步的研究来优化DCT的实施和减轻现场负担.
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