在瘤学临床试验实施过程中通过临床内容干预预防潜在的患者伤害
Vivian C Loo1, Sarah Kim1, Lisa M Johnson1
1From the Departments of Protocol Content Administration.
Journal of patient safety
|August 24, 2023
概括
对瘤学临床试验文件的集中审查在17.1%的病例中确定了潜在的患者安全干预措施 (PPSI),主要与药物剂量有关. 这凸显了专家审查的必要性,以确保临床试验中的患者安全.
科学领域:
- 在瘤学瘤学.
- 临床试验管理 临床试验管理
- 患者安全 患者安全
背景情况:
- 临床试验文件是复杂的,容易出现不一致.
- 这些不一致性可能导致试验实施中的错误,并危及参与者的安全.
研究的目的:
- 确定行政和潜在的患者安全干预 (PPSI) 的频率和类型.
- 在审查瘤学试验文件期间分析这些干预措施,以便由临床内容专家实施.
主要方法:
- 一个由集中临床内容专家组成的团队在一年内审查了试验文件 (协议,实验室手册,药房手册).
- 干预被归类为行政或PPSI (药物,实验室,程序相关或其他).
- 试验按研究阶段和赞助商类型进行分类.
主要成果:
- 在585项审查的试验中,有46%需要干预;在1001项干预中,有17.1%是PPSI.
- 与药物相关的PPSI是最常见的 (45.6%),特别是药物剂量错误 (53.8%).
- 第1阶段试验和研究人员发起的试验显示,每项试验的PPSI比例最高.
结论:
- 在临床试验文档评估过程中,患者安全存在重大差距.
- 利用临床专家的集中团队进行预防性审查可以提高患者的安全性.
- 积极审查临床试验文件对于安全进行临床试验至关重要.
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