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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.

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概括
此摘要是机器生成的。

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.

关键词:
临床研究协议 临床研究协议临床研究的设计.临床试验成本临床试验成本临床试验周期时间临床试验的设计分散的临床试验 (DCT)协议复杂性 协议复杂性协议设计 协议设计网站负荷负担 网站负担

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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.