A method to assess the proportion of treatment effect explained by a surrogate endpoint
A method to assess the proportion of treatment effect explained by a surrogate endpoint
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DOI：
10.1002/sim.984
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发表时间：
2001-11-15
影响因子：
2
通讯作者：
Hoseyni, MS
中科院分区：
文献类型：
--
作者：
Li, ZQ;Meredith, MP;Hoseyni, MS
随机临床试验是评估新药、设备和程序的标准。传统的临床试验不仅需要大量的费用，而且需要相当长的时间才能完成。使用替代终点有助于控制临床试验的成本和完成时间。我们提出了一种基于包括常用的线性、Logistic和Cox回归模型的一般模型设置来量化由替代终点解释的治疗效果的比例的方法。通过图形显示，便于对这一定量测量进行解释。为了减少与估计相关的变异性，提出了一种基于随机效应模型的元分析方法。给出了一个使用实际临床试验数据的例子来说明所提出的步骤。版权所有(C)2001 John Wiley&Sons，Ltd.
Randomized clinical trials are the standard for evaluating new drugs, devices and procedures. Traditional clinical trials entail not only considerable expense, but require considerable time to complete. The use of surrogate endpoints constitates an effort to control cost and completion time for clinical trials. We propose a method to quantify the proportion of treatment effect explained by a surrogate endpoint based on a general model setting which includes the commonly used linear, logistic and Cox regression models. The interpretation of this quantitative measure is facilitated by graphical displays. To reduce the variability associated with the estimate, a meta-analytic approach is proposed based on random effects models. An example using real clinical trial data is given to illustrate the proposed procedures. Copyright (C) 2001 John Wiley & Sons, Ltd.