评估研究启动延迟对癌症研究积累的影响
Isuru Ratnayake1, Anh-Tuan Do2, Daniel Gajewski3
1Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, USA.
Contemporary clinical trials communications
|November 10, 2025
概括
简化临床试验启动加速了患者获得癌症治疗的机会. 具有较高患者积累率的成功试验显示更短的激活时间,改善了整体项目成功.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药物开发 药物开发
背景情况:
- 癌症医学临床试验的成功取决于高效的设计,优化和执行.
- 研究启动的延迟,往往超过六个月,大大阻碍了进展.
- 监管障碍,合同谈判和现场激活效率低下导致这些延迟.
研究的目的:
- 分析临床试验累计成功和研究激活时间之间的关系.
- 确定影响试验激活时间表和项目成功的因素.
主要方法:
- 使用了堪萨斯大学癌症中心 (KUCC) 的数据,用于2018年至2022年期间启动的研究.
- 基于注册参与者与目标的计算累计百分比.
- 使用预定义的值 (50%,70%,90%) 和分析的中位激活时间来定义累积成功.
主要成果:
- 达到或超过70%积累值的研究的中位激活时间为140.5天,相比之下,不足的研究的激活时间为187天.
- 早期阶段的研究显示激活时间比后期阶段的研究要长得多 (Wilcoxon排列和试验,p=0.001).
- 在50%和90%的累计门上,调查结果保持一致.
结论:
- 较短的中位激活时间与更高的临床试验成功率相关.
- 减少审批过程中的障碍可以加快审批速度,并在所有阶段提高研究成功率.
- 优化研究启动对于患者及时获得新型癌症疗法至关重要.
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