受规模和功率限制的临床试验的精确样本量

Pub Date : 2024-08-29 DOI:10.1111/anzs.12424
Chris J. Lloyd
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引用次数: 0

摘要

摘要 本文首先介绍了为临床试验提供所需的样本量以保证 1 型和 2 型误差控制所面临的困难。所需的样本量显然取决于所采用的检验,在本研究中,我们采用了所谓的 E 检验,众所周知,该检验具有极其有利的样本量特性,且比其他检验具有更高的功率。实时计算该测试的精确幂目前并不可行,因此我们创建了一个预先计算精确幂(和大小)的语料库,涵盖的样本量最高可达 500 个。当语料库中没有解决方案时,就会使用一种新颖的外推法。在提取样本大小后,可以计算精确大小;不过,对于 E 测试,精确大小几乎总是非常接近标称目标。所有代码都已转换成 R 包,可在 CRAN 上获取,并附有图解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Exact samples sizes for clinical trials subject to size and power constraints

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Exact samples sizes for clinical trials subject to size and power constraints

This paper first describes the difficulties in providing the required sample sizes for clinical trials that guarantee type 1 and type 2 error control. The required sample sizes obviously depend on the test employed, and in this study we use the so-called E-test, which is known to have extremely favourable size properties and higher power than alternatives. To compute exact powers for this test in real time is not currently feasible, so a corpus of pre-computed exact powers (and sizes) was created, covering sample sizes up to 500. When there are no solutions within the corpus, a novel extrapolation technique is used. Exact size can be computed after the sample sizes have been extracted; however, for the E-test the exact size is virtually always very close to the nominal target. All the code has been converted into an R-package, which is available on CRAN and illustrated.

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