与抗癌药物的临床试验参与相关的生存益处:系统性审查和元分析
Renata Iskander1, Hannah Moyer2, Karine Vigneault1
1Department of Equity, Ethics and Policy, McGill University, Montreal, Quebec, Canada.
JAMA
|May 20, 2024
概括
参与癌症临床试验可能不会提高存活率. 高质量的研究表明,与常规护理相比,试验中患者的生存没有显著的好处,这表明仅仅参与试验并不能改善结果.
科学领域:
- 癌症学
- 临床试验
- 生物统计学
背景情况:
- 许多瘤学家认为, 癌症临床试验与标准治疗相比,
- 然而,从参与试验 (参与效应) 直接证明生存益处的强有力的证据仍然难以捉摸.
研究的目的:
- 系统地审查和对参与癌症试验与改善整体存活率与常规临床护理相关的证据进行元分析.
- 评估研究质量和偏差对观察到的生存结果的影响.
主要方法:
- 使用PubMed和Embase数据库进行了系统的文献搜索,并补充了引用搜索.
- 包括比较癌症试验参与者和接受常规护理的患者的整体存活期的研究.
- 数据由独立编码人员提取并评估质量,并使用随机效应模型进行元分析,根据研究质量和偏差控制分层.
主要成果:
- 分析了39个出版物,其中包括85个比较.
- 所有研究的初始组合表明试验参与者的生存益处显著 (HR,0. 76).
- 然而,在匹配的队列研究中,这种益处减少了 (HR,0. 85) 在高质量的研究中消失了 (HR,0. 91) 和在调整出版偏差后 (HR,0. 94).
结论:
- 虽然许多研究表明癌症试验参与者的生存优势,但这些发现通常归因于偏见和混因素.
- 控制偏差和混的高质量研究不支持参与试验的独立生存益处.
- 这些结果挑战了参与试验本身会带来更好的生存结果的观点.
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