在白血病临床试验中分析试验过早中止的决定因素
Lara K Rotter1,2, Abdulrahman Alhajahjeh3,4, Jessica M Stempel1
1Department of Internal Medicine, Hematology Section, Yale School of Medicine, Yale Comprehensive Cancer Center, New Haven, CT, USA.
Leukemia & lymphoma
|October 23, 2024
概括
许多白血病临床试验提前结束,主要是由于患者积累缓慢. 这一趋势随着时间的推移而恶化,受影响最大的是学术赞助和早期阶段的试验.
科学领域:
- 血液学 血液学 血液学
- 临床试验管理 临床试验管理
- 瘤学研究研究
背景情况:
- 临床试验对于推进患者护理和治疗结果至关重要.
- 很大一部分临床试验在未完成之前就被停止,这影响了研究进展.
- 导致试验过早终止的因素,特别是在白血病研究中,需要进一步阐明.
研究的目的:
- 调查白血病临床试验中早产的频率和原因.
- 在20年期间,确定白血病试验终止率的趋势.
- 分析与早期试验终止相关的因素.
主要方法:
- 我们对ClinicalTrials.gov进行了系统的搜索,搜索了2000年至2020年期间注册的白血病试验.
- 数据提取是由两个独立的审查员进行的.
- 使用统计分析来确定终止率和相关因素.
主要成果:
- 在3522个确定的白血病试验中,28.4%被提前终止.
- 缓慢的患者积累是终止的主要原因,在38.2%的病例中被引用.
- 终止率显著增加,从17.0% (2000年至2005年) 增加到30.9% (2010至2015年).
- 与更高的终止率相关的因素包括学术赞助,早期试验阶段,顺序分配,单中心设计和非随机化.
- 与较小的试验相比,较大的试验的终止率较低.
结论:
- 早期终止是白血病临床试验中的一个重大挑战.
- 缓慢累积是早期停止试验的主要原因.
- 趋势表明随着时间的推移,终止率越来越高,突出显示需要改进试验设计和管理策略.
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