Mid-trial design reviews for sequential clinical trials.
Mid-trial design reviews for sequential clinical trials.
复制标题
序贯临床试验的中期试验设计审查。
DOI：
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发表时间：
2001
影响因子：
2
通讯作者：
M. Sooriyarachchi
中科院分区：
文献类型：
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作者：
J. Whitehead;A. Whitehead;S. Todd;K. Bolland;M. Sooriyarachchi
当通过绘制测量治疗差异的统计数据与另一测量信息的曲线来进行连续临床试验时，无论干扰参数如何，都能保证功效。然而，为了获得样本量分布的印象，需要将值分配给滋扰参数。每次中期分析都提供了重新评价样本量与信息之间关系的机会。在本文中，我们讨论这样的中期试验设计审查。在招募阶段相对较短，随后随访时间较长的试验以及回复呈正态分布的特殊情况下，试验中期设计审查尤为重要。例子给出的各种情况下考虑，和广泛的模拟报告证明的情况下，正态分布的响应的审查程序的有效性。
When sequential clinical trials are conducted by plotting a statistic measuring treatment difference against another measuring information, power is guaranteed regardless of nuisance parameters. However, values need to be assigned to nuisance parameters in order to gain an impression of the sample size distribution. Each interim analysis provides an opportunity to re-evaluate the relationship between sample size and information. In this paper we discuss such mid-trial design reviews. In the special cases of trials with a relatively short recruitment phase followed by a longer period of follow-up, and of normally distributed responses, mid-trial design reviews are particularly important. Examples are given of the various situations considered, and extensive simulations are reported demonstrating the validity of the review procedure in the case of normally distributed responses.