跨国随机临床试验的交付障碍
Denise van Hout1, Paul Mouncey2, David Harrison2
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
JAMA network open
|July 2, 2025
概括
伦理,行政,监管和后勤 (EARL) 程序显著延迟了临床试验. 与其他欧洲国家相比,英国的合同完成和批准时间要快得多,特别是在COVID-19大流行期间.
科学领域:
- 临床试验操作临床试验操作
- 监管科学是一种监管科学.
- 公共卫生准备 公共卫生准备
背景情况:
- 伦理,行政,监管和后勤 (EARL) 程序经常阻碍临床试验的交付.
- 量化这些障碍对于确定改善试验效率的领域至关重要.
研究的目的:
- 识别和量化临床试验交付中的EARL障碍.
- 为了在欧洲国家中比较COVID-19大流行前和期间的这些障碍.
主要方法:
- 一项队列研究分析了社区获得肺炎随机嵌入式多因素适应性平台试验的数据.
- 对欧洲19个国家的多个协议进行了EARL程序的比较,这些程序是在大流行前和大流行期间.
- 分析了合同和协议提交数据,以合同完成的时间,监管和伦理审批 (TTA) 的时间和首位患者入院 (FPI) 的时间作为关键指标.
主要成果:
- 在英国,在大流行期间,合同完成时间减少了97% (中位数为5天,而大流行前为196天).
- 非英国国家在合同完成方面表现的改善较小 (183天与224天的流行前).
- 在大流行期间,英国的TTA比非英国国家 (中位数为115天) 快得多 (中位数为8天),英国试验也在3个月内更快地到达第一个患者.
结论:
- 由于不同的监管解释,EARL程序是漫长的,并且在欧洲国家之间存在很大差异.
- 与其他欧洲国家相比,英国的试验启动过程明显更快.
- 简化欧洲的EARL流程对于提高临床试验效率至关重要,特别是在公共卫生紧急情况下.
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