Ethical issues in stopping randomized trials early because of apparent benefit
Ethical issues in stopping randomized trials early because of apparent benefit
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DOI：
10.7326/0003-4819-146-12-200706190-00009
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发表时间：
2007-06-19
影响因子：
39.2
通讯作者：
Guyatt, Gordon H.
中科院分区：
文献类型：
--
作者：
Mueller, Paul S.;Montori, Victor M.;Guyatt, Gordon H.
因为一个明显的好处而提前停止随机试验变得越来越普遍。为了保护和促进试验参与者的利益，研究者可能会因为研究治疗的明显获益（与安慰剂或其他治疗相比）而感到有义务提前停止试验。然而，这样做存在严重的道德问题。截断试验系统性地高估了治疗效果;在累积结局事件数量较少的情况下，高估可能非常大。产生严重夸大的治疗效果估计违反了科学有效性的伦理研究要求。随后使用夸大的估计来告知临床决策和实践指南，违反了社会价值和有利的风险受益比的伦理要求。研究人员应该确保在停止试验之前积累大量的结果事件，然后继续招募以评估积极的趋势是否继续。这可以平衡保护研究参与者的需要与科学有效性，社会价值和有利的风险效益比的伦理要求。
Stopping randomized trials early because of an apparent benefit is becoming more common. To protect and promote the interests of trial participants, investigators may feel obligated to stop a trial early because of the apparent benefit of a study treatment (compared with placebo or other treatment). There are, however, serious ethical problems with doing so. Truncated trials systematically overestimate treatment effects; in cases where the number of accrued outcome events is small, the overestimation may be very large. Generating seriously inflated estimates of treatment effect violates the ethical research requirement of scientific validity. Subsequent use of inflated estimates to inform clinical decision making and practice guidelines violates the ethical requirements of social value and a favorable risk-benefit ratio. Researchers should ensure that a large number of outcome events accrues before stopping a trial and then continue recruitment to assess whether positive trends continue. This can balance the need to protect research participants with the ethical requirements of scientific validity, social value, and a favorable risk-benefit ratio.