Suppr超能文献

多中心临床试验样本量的优化分配

Optimal allocation of sample sizes to multicenter clinical trials.

作者信息

Lai Dejian, Chang Kuang-Chao, Rahbar Mohammad H, Moye Lemuel A

机构信息

Division of Biostatistics, University of Texas School of Public Health, Houston, TX 77030, USA.

出版信息

J Biopharm Stat. 2013;23(4):818-28. doi: 10.1080/10543406.2013.789884.

Abstract

In this article, we discuss an approach for optimal sample size allocation in designing multicenter clinical trials. The method we studied was adapted from a stratified sampling survey design. The sample size allocated to centers is a function of the center's treatment cost, the standard deviation of the endpoint, and the availability of patients. We illustrate our approach using two hypothetical scenarios derived from our experiences in designing and conducting multicenter clinical trials. Simulation results are also presented.

摘要

在本文中,我们讨论了一种在多中心临床试验设计中进行最优样本量分配的方法。我们研究的方法改编自分层抽样调查设计。分配给各中心的样本量是该中心治疗成本、终点指标标准差以及患者可得性的函数。我们通过从设计和开展多中心临床试验的经验中得出的两个假设情景来说明我们的方法。同时还给出了模拟结果。

相似文献

7
Sample size allocation to regions in a multiregional trial.多区域试验中各区域的样本量分配
J Biopharm Stat. 2009 Jul;19(4):580-94. doi: 10.1080/10543400902963185.
9
How to design a clinical trial.如何设计一项临床试验。
Methods Mol Med. 2003;86:475-89. doi: 10.1385/1-59259-392-5:475.

本文引用的文献

2
An issue of statistical analysis in controlled multi-centre studies: how shall we weight the centres?
Stat Med. 1999 Feb 28;18(4):365-73. doi: 10.1002/(sici)1097-0258(19990228)18:4<365::aid-sim46>3.0.co;2-2.
3
Some controversies in planning and analysing multi-centre trials.多中心试验规划与分析中的一些争议。
Stat Med. 1998;17(15-16):1753-65; discussion 1799-800. doi: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1753::aid-sim977>3.0.co;2-x.
4
Sizing clinical trials with variable endpoint event rates.
Stat Med. 1997 Oct 30;16(20):2267-82. doi: 10.1002/(sici)1097-0258(19971030)16:20<2267::aid-sim671>3.0.co;2-1.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验