测试癌症查是否拯救生命:对多种癌症查随机临床试验的含义
H Gilbert Welch1, Tanujit Dey1
1Center for Surgery & Public Health, Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
JAMA internal medicine
|August 28, 2023
概括
多种癌症查血液检查可能会降低全因死亡率,但需要大型试验来证实. 研究人员计算了癌症查试验的样本大小,发现多种癌症查需要更少的参与者来评估整体生存益处.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 癌症查旨在降低死亡率,新的多种癌症检测血液测试 (液体活检) 越来越引起人们的兴趣.
- 以往针对个体癌症查的随机临床试验 (RCT) 通常需要超过10万名参与者来显示癌症特异性死亡率的降低.
- 在个别癌症查RCT中评估全因死亡率需要超过100万名参与者,这带来了重大可行性挑战.
研究的目的:
- 探索推动研究的可行性,以评估癌症查中的癌症特异性与全因死亡率.
- 确定随机临床试验的样本大小要求,评估多种癌症查对死亡率的影响.
主要方法:
- 对选定个别癌症 (乳腺癌,结肠直肠癌,肝癌,胰腺癌,前列腺癌) 和所有癌症进行了样本大小计算.
- 在单个和多种癌症查场景中,比较了测试癌症特异性死亡率与所有原因死亡率的样本大小需求.
主要成果:
- 个别癌症查试验需要大样本大小 (≥100,000对于癌症特异性,>100万对于全因死亡率).
- 多种癌症查试验可以评估不到10万名参与者的全因死亡率,因为癌症死亡对整体死亡率的重大贡献.
- 关于癌症查效果的观察数据被认为是误导性的;RCT对于有效性和危害评估都至关重要.
结论:
- 在多种癌症查中,可以进行评估全因死亡率的RCT,而不是单个癌症查.
- 多种癌症查虽然有希望,但会带来潜在的成本和危害,需要通过RCT进行严格的评估.
- 随机临床试验是强制性的,以确定多种癌症查的救命潜力和安全性.
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