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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。

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本文引用的文献

1
Sample size calculation for multicenter randomized trial: taking the center effect into account.
Contemp Clin Trials. 2007 Jul;28(4):451-8. doi: 10.1016/j.cct.2006.11.003. Epub 2006 Nov 17.
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.
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.
5
Sample size determination for group sequential clinical trials with immediate response.
Stat Med. 1992 Jul;11(10):1391-9. doi: 10.1002/sim.4780111012.

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