Sequential meta-analysis of past clinical trials to determine the use of a new trial
Sequential meta-analysis of past clinical trials to determine the use of a new trial
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DOI：
10.1097/01.ede.0000239658.19288.22
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发表时间：
2006-11-01
期刊：
影响因子：
5.4
通讯作者：
van der Tweel, Ingeborg
中科院分区：
文献类型：
--
作者：
Bollen, Casper W.;Uiterwaal, Cuno S. P. M.;van der Tweel, Ingeborg
背景：临床试验可以根据中期分析或序贯分析提前停止。原则上，序贯分析还可用于确定在已完成的试验中是否收集了足够的证据，从而无需进行进一步的试验。我们通过对比较治疗早产新生儿的通气方法的临床试验进行回顾性分析来证明这种应用。方法：我们确定了最近 5 项比较高频通气与传统机械通气在早产儿治疗中的试验。死亡或慢性肺病以及幸存者的慢性肺病是主要的临床结果。我们对这 5 项研究进行了序贯荟萃分析。结果：在序贯荟萃分析中纳入最后 5 项试验的第一项研究后，两种结局（死亡或慢性肺病）都跨越了“无临床相关效应”的界限。使用减少假定的临床相关效应大小的敏感性分析在 2 项试验后显示出相同的结果。结论：序贯荟萃分析显示，在 5 项试验中的第一个试验后，已确定缺乏临床相关效应。如果这样的分析是在第一次或第二次临床试验之后进行的，则可能会导致后续试验的研究设计发生变化，甚至导致重新评估进一步试验的必要性。
Background: Clinical trials can be stopped early based on interim analyses or sequential analyses. In principle, sequential analyses can also be used to decide whether enough evidence has been gathered in completed trials to make further trials unnecessary. We demonstrate such an application through a retrospective analysis of clinical trials comparing ventilation methods for the treatment of preterm newborns.Methods: We identified 5 recent trials that compared high-frequency ventilation with conventional mechanical ventilation in the treatment of preterm newborns. Death or chronic lung disease and chronic lung disease in survivors were the primary clinical outcomes of interest. We applied sequential meta-analyses to these 5 studies.Results: After including the first study of the last 5 trials in a sequential meta-analysis, the boundary of "no clinically relevant effect" was crossed for both outcomes (death or chronic lung disease). A sensitivity analysis using a reduction in the size of assumed clinically relevant effect showed the same findings after 2 trials.Conclusions: Sequential meta-analyses showed that a lack of clinically relevant effect had been established after the first of the 5 trials. If such an analysis had been conducted after the first or second of these clinical trials, it might have led to changes in the study design of subsequent trials or even to a reassessment of the need for further trials.