外部控制的临床试验中的信息审查:一种潜在的偏见来源
T Rudra Gupta1, D E Schwartz1, R Saha1
1Dana-Farber Cancer Institute, Boston, USA; Harvard School of Public Health, Boston, USA.
ESMO open
|January 4, 2025
概括
外部控制数据中的信息审查可能会导致癌症临床试验结果偏差,影响统计能力和错误率. 研究人员在试验设计中使用外部数据时必须考虑这种偏差.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 癌症研究 癌症研究
背景情况:
- 在癌症临床试验中使用外部数据是常见的,但可能会引入偏见.
- 信息审查,审查和生存时间之间的统计依赖,是一个经常被忽视的偏见来源.
研究的目的:
- 研究外部控制的信息审查对癌症临床试验结果的影响.
- 评估信息审查如何影响模拟癌症试验中的偏见,I型错误和权力.
主要方法:
- 单臂和随机对照癌症临床试验的模拟.
- 包括基于模型的复制品和in silico质母细胞瘤试验.
- 信息审查的建模与审查和生存时间之间的积极或消极关联.
主要成果:
- 对外部对照数据的信息审查显然会影响癌症临床试验结果.
- 偏差的方向和大小取决于特定的审查机制.
- 信息审查可以导致通货膨胀或降低I型错误和统计能力.
结论:
- 结合外部数据的临床试验设计必须解决信息审查带来的偏见风险.
- 检测信息审查的分析对于使用外部控制数据的试验至关重要.
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