在癌症试验中的入学成功,因素和预测模型 (2008-2019)
Siqi Zhang1,2,3, Jianrong Zhang4,5, Sida Liu6
1Duke Cancer Institute, Duke University, Durham, NC.
JCO oncology practice
|October 4, 2023
概括
自2008年以来,癌症临床试验入学成功率一直在下降. 试验阶段和赞助商类型等因素影响成功,为癌症试验的未来招聘策略提供信息.
科学领域:
- 在瘤学瘤学.
- 临床试验管理 临床试验管理
- 生物统计学 生物统计学
背景情况:
- 招生成功对于推动癌症研究和药物开发至关重要.
- 了解影响入学率的因素是优化临床试验设计和执行的关键.
研究的目的:
- 调查2008年至2019年间癌症临床试验的入学成功率.
- 确定与这些试验中入学成功率较低相关的因素.
主要方法:
- 一项横截面研究分析了在ClinicalTrials.gov.gov上注册的4,004项癌症临床试验 (乳腺癌,肺癌,结直肠癌).
- 招生成功定义为达到预计招生目标的≥85%.
- 多变量逻辑回归用于评估试验特征与入学成功之间的关联.
主要成果:
- 总体入学成功率为49.1%,从2014-2019年显著下降.
- 与较低成功率相关的因素包括晚期激活年,早期阶段试验 (I,I/II,II与III),政府赞助,没有健康的志愿者,以及更大的招生目标.
- 使用安慰剂比较剂,多个位置 (≥5) 和更多次要终点 (≥5) 的试验显示出更高的成功率.
结论:
- 在研究期间,癌症临床试验入学成功率有所下降.
- 识别影响注册的关键因素可以指导为未来的癌症试验开发改进的招聘策略.
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