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Survival analysis more than meets the eye

机译:生存分析超越眼界

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摘要

The log-rank test is a cornerstone of phase III oncology clinical trials. However, there are at least three different mathematical procedures that can be named the log-rank test and two of them are widely used by commercial statistical programs. Consequently, different P values can be obtained. In the case of a borderline statistical significance, this can mean the difference between the evidence (significant P value) and merely an observation. Since all three methods can be reported under the same name, space for possible data manipulation occurs. This should be of a particular concern in a drug regulatory context. Randomized clinical trials with borderline significant results should perhaps be required to report P values calculated by all three methods, in order to properly evaluate drug efficacy. An interactive MS Excel spreadsheet that uses all three logrank test variants is prepared as a supplementary file accompanying this article. Association of high grade of bone marrow fibrosis with poor outcome in patients with myelofibrosis is used as an example.
机译:对数秩检验是III期肿瘤学临床试验的基础。但是,至少有三种不同的数学程序可以称为对数秩检验,其中两种被商业统计程序广泛使用。因此,可以获得不同的P值。在具有统计学显着性的情况下,这可能意味着证据(显着的P值)与观察值之间的差异。由于可以使用相同的名称报告所有这三种方法,因此会出现用于可能的数据操作的空间。在药品监管方面,这应该是一个特别令人关注的问题。为了正确评估药物疗效,可能应要求随机临床试验报告明显的临界结果,以报告通过所有三种方法计算出的P值。随附了使用所有三个logrank测试变体的交互式MS Excel电子表格,作为本文的补充文件。以骨髓纤维化患者中高级别的骨髓纤维化与不良预后的关联为例。

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