仿真作为成功启动临床试验的潜在工具
Rita Dadiz1, Rachel Jones1, Ronnie Guillet1
1Division of Neonatology, Department of Pediatrics, Golisano Children's Hospital, University of Rochester Medical Center, Rochester, NY, USA.
Journal of clinical and translational science
|December 10, 2024
概括
模拟练习通过在影响研究结果之前识别潜在的挑战来增强临床试验准备. 在随机临床试验中的这种主动方法可以减少协议偏差和违规.
科学领域:
- 临床药房 临床药房
- 神经学 神经学
- 儿科 儿科 儿科
背景情况:
- 临床试验是复杂的,涉及许多利益相关者和潜在的不可预见的挑战.
- 经验丰富的研究人员可能无法预见可能危及研究完成的所有问题.
研究的目的:
- 描述模拟的应用在准备一个随机临床试验的新抗发作药物在新生儿.
- 通过模拟识别利益相关者,开发场景,并确定潜在的挑战.
主要方法:
- 利益相关者识别和角色定义.
- 基于试验程序的场景开发.
- 模拟练习以识别障碍和复杂性.
主要成果:
- 模拟突出了试验准备的潜在好处.
- 确定了模拟过程中固有的挑战.
- 发现了在程序手册中没有明显的研究特异性复杂性.
结论:
- 模拟练习可以主动识别临床试验中的障碍和复杂性.
- 这种方法可能会导致更少的协议偏差和违规.
- 模拟提供了一种实际的方法来提高临床试验准备.
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