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Sequential parallel comparison design with two coprimary endpoints

机译:与两个平行的平行比较设计,具有两个平行终点

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A placebo‐controlled randomized clinical trial is required to demonstrate that an experimental treatment is superior to its corresponding placebo on multiple coprimary endpoints. This is particularly true in the field of neurology. In fact, clinical trials for neurological disorders need to show the superiority of an experimental treatment over a placebo in two coprimary endpoints. Unfortunately, these trials often fail to detect a true treatment effect for the experimental treatment versus the placebo owing to an unexpectedly high placebo response rate. Sequential parallel comparison design (SPCD) can be used to address this problem. However, the SPCD has not yet been discussed in relation to clinical trials with coprimary endpoints. In this article, our aim was to develop a hypothesis‐testing method and a method for calculating the corresponding sample size for the SPCD with two coprimary endpoints. In a simulation, we show that the proposed hypothesis‐testing method achieves the nominal type I error rate and power and that the proposed sample size calculation method has adequate power accuracy. In addition, the usefulness of our methods is confirmed by returning to an SPCD trial with a single primary endpoint of Alzheimer disease‐related agitation.
机译:需要进行安慰剂对照的随机临床试验,以证明实验治疗在多个主要终点上优于相应的安慰剂。在神经学领域尤其如此。事实上,神经系统疾病的临床试验需要证明实验治疗在两个主要终点优于安慰剂。不幸的是,由于安慰剂应答率出人意料地高,这些试验往往无法检测到实验治疗与安慰剂的真正治疗效果。顺序并行比较设计(SPCD)可以用来解决这个问题。然而,SPCD尚未与具有主要终点的临床试验进行讨论。在这篇文章中,我们的目标是开发一种假设检验方法和一种计算具有两个主要终点的SPCD相应样本量的方法。在一个模拟中,我们证明了所提出的假设检验方法达到了标称I型错误率和功率,并且所提出的样本量计算方法具有足够的功率精度。此外,我们的方法的有效性通过回到一项SPCD试验得到证实,该试验的一个主要终点是阿尔茨海默病相关的躁动。

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