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抗癌药物的开放性试验中的检测偏差:一项超流行病学研究
Satoshi Funada1,2, Yan Luo3, Yuki Kataoka4,5,6,7
1Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine and Faculty of Medicine / School of Public Health, Kyoto, Japan sfunada@kuhp.kyoto-u.ac.jp.
BMJ evidence-based medicine
|August 16, 2023
概括
在癌症试验中的当地调查人员显示,对无进展生存期 (PFS) 和客观反应率 (ORR) 的估计过高. 建议中央审查员,但它们对偏见的影响需要进一步研究.
科学领域:
- 在瘤学瘤学.
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
背景情况:
- 在开放标签的抗癌试验中,建议中央审查人员减轻当地调查人员的检测偏见.
- 在评估无进展生存率 (PFS) 和客观反应率 (ORR) 中偏差的程度和一致性仍然不清楚.
研究的目的:
- 在瘤学开放标签试验中评估检测偏差.
- 确定与中央审查员相比,当地调查人员是否高估了PFS和ORR.
主要方法:
- 对开放标签,随机抗癌试验 (2010-2021) 的超流行病学研究.
- 由中央审查人员与当地调查人员裁决的PFS和ORR进行了比较.
- 使用随机效应模型计算PFS的危险比率比率 (RHR) 和ORR的几率比率比率 (ROR).
主要成果:
- 包括114项用于元分析的试验 (PFS: 92,ORR: 74).
- 对于PFS,危险比率 (RHR) 的比率为0.95 (95% CI为0.910.98),表明中央评审者略微低估了这一数字.
- ORR的几率比率 (ROR) 为1.00 (95% CI 0.911.09),没有显著差异.
结论:
- 当地调查人员的高估对在开放标签瘤学试验中对PFS和ORR评估的影响很小.
- 局限性包括不完整的数据,可能低估了检测偏差.
- 需要进一步的研究,以充分评估中央审查员的必要性.
关键词:
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