在瘤学临床试验中的协议修订经验的新基准
Emily Botto1, Zachary Smith2, Kenneth Getz2
1Tufts University School of Medicine, 145 Harrison Ave, Boston, MA, 02111, USA. Emily.botto@tufts.edu.
Therapeutic innovation & regulatory science
|March 26, 2024
概括
瘤学临床试验经历了比非瘤学试验更多的协议修正,导致参与者完成率较低. 试图在癌症药物开发中减少这些修正案的努力是无效的.
科学领域:
- 临床试验 临床试验
- 药物开发 药物开发
- 在瘤学瘤学.
背景情况:
- 瘤药物开发的复杂性正在增加,这是由狭窄的患者群体和复杂的程序所驱动的.
- 这项研究调查了瘤学和非瘤学临床试验之间的差异,以确定性能优化机会.
研究的目的:
- 在瘤学与非瘤学临床试验中比较协议修订的影响和原因.
- 识别导致瘤学试验复杂性和性能因素.
主要方法:
- 分析了来自16家公司的950个协议和2,188个修正案的数据.
- 在249个瘤学和701个非瘤学协议之间进行了比较分析.
主要成果:
- 瘤学协议显示更高的流行率 (91.1%) 和数量 (4.0) 的修订与非瘤学 (72.1%,3.0) 相比.
- 有修正的瘤学试验的参与者完成率明显较低.
- 在瘤学试验中,COVID-19大流行加剧了修正数量,完成率较低,瘤学试验中学率较高.
结论:
- 在瘤学试验中防止可避免的协议修改仍然是一个重大挑战.
- 越来越复杂的瘤学试验设计有助于不可预测的时间表,招聘/保留障碍,以及更多的修正.
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