临床试验激活过程:意大利一家公共医院的案例研究
Carolina Pelazza1, Marta Betti2, Francesca Marengo2
1Research Training Innovation Infrastructure, Research and Innovation Department (DAIRI), Azienda Ospedaliero-Universitaria SS. Antonio E Biagio E Cesare Arrigo, Alessandria, Italy. carolina.pelazza@esterni.ospedale.al.it.
Trials
|April 5, 2024
概括
简化临床试验激活显著减少了研究启动时间. 研究与创新部 (DAIRI) 的重组流程将平均试验激活时间从218天缩短到56天.
科学领域:
- 临床研究管理 临床研究管理
- 医疗保健管理创新 医疗保健管理创新
- 医疗保健中的流程优化
背景情况:
- 全球的研究机构正在优化临床试验激活途径,以吸引赞助商.
- 亚历山大公共医院的研究和创新部门 (DAIRI) 旨在改善其试验激活流程.
- 重组工作重点是提高试验赞助的效率和吸引力.
研究的目的:
- 分析和重组DAIRI的试验启动阶段.
- 实施一个新的组织模式来激活试验.
- 减少临床试验启动所需的总体时间.
主要方法:
- 一个合作项目,涉及临床试验中心 (CTC),伦理委员会秘书处 (ESC) 和行政协调 (AC).
- 使用精益思维方法和A3报告工具进行流程分析.
- 在八个四个月期间监控关键绩效指标 (KPIs),以跟踪激活时间表.
主要成果:
- 平均试验激活时间从218天减少到56天.
- 观察到CTC (55至23天),ECS (25至8天) 和AC (29至10天) 的平均激活时间显著减少.
- 与没有 (46天) 相比,有协议的研究仍然具有更长的激活时间 (100天).
结论:
- 临床和行政人员的专业培训对于有效的试验激活至关重要.
- 该项目产生了一个标准操作程序和一个KPI监控工具.
- 开发的方法和工具可转移到其他临床中心以改进过程.
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