远程和半自动化方法进行分散的随机临床试验
Teresa Cafaro1,2,3, Patrick J LaRiccia3,4, Brigid Bandomer3
1Department of Anesthesiology, Cooper University Health Care, Camden, NJ, USA.
Journal of clinical and translational science
|August 2, 2023
概括
远程和自动化方法能够有效地管理临床试验,改善受试者招募,坚持和数据完整性. 这种方法提高了效率,而不会影响研究的安全性或质量.
科学领域:
- 临床研究方法论临床研究方法论
- 数字卫生技术数字卫生技术
- 医疗保健创新 医疗保健创新
背景情况:
- 临床试验在时间和人力资源方面面临挑战.
- 远程和自动化方法为高效的试验进行提供了潜在的解决方案.
研究的目的:
- 描述使用远程和自动化过程进行随机临床试验的方法.
- 在现实环境中证明这些方法的可行性和有效性.
主要方法:
- 使用了一种涉及医疗保健工作者的随机临床试验模型.
- 招聘,查,知情同意和数据收集都是远程和自动执行的.
- 研究产品的分发和遵守监测是通过邮件和电子调查进行的.
主要成果:
- 一个小团队远程选了406名受试者,并在3个月内招募了299名受试者.
- 在9个月内实现了87%的研究产品遵守率和98.5%的数据完整性.
- 报告的可用性得分很高 (93.8%的参与者,90%的员工).
结论:
- 远程和自动化方法提高了临床试验的效率,招聘,坚持和数据质量.
- 这些方法保持安全和质量标准.
- 提供了一个XML模板,以促进未来远程临床试验的设计.
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