Surrogate endpoint validation: statistical elegance versus clinical relevance
Surrogate endpoint validation: statistical elegance versus clinical relevance
复制标题
DOI：
10.1177/0962280207081863
复制
发表时间：
2008-10-01
影响因子：
2.3
通讯作者：
Sargent, Daniel J.
中科院分区：
文献类型：
--
作者：
Green, E. M.;Yothers, G.;Sargent, Daniel J.
已经提出了各种方法来提供对所建议的替代标记的正式和非正式验证。为了达到真正的临床效果，验证必须说服统计和临床团体。在本文中，我们认为最好的方法不是单一的方法，而是多方面的探索，使用多种方法，包括那些直接吸引临床医生但统计学基础较少的方法，以及那些产生于统计学考虑但临床难以解释的方法。我们使用早期和晚期结直肠癌的临床试验数据来说明我们的方法。
A variety of approaches have been proposed to provide formal and informal validation of proposed surrogate markers. To achieve true clinical impact, the validation mast convince both the statistical and clinical communities. In this paper, we argue that the best approach is not a single method but a multi-faceted exploration, using multiple approaches, including those that directly appeal to clinicians but with less statistical foundation and those arising from statistical considerations but snore difficult to interpret clinically. We illustrate our approach using data from clinical trials in both early and advanced colorectal cancer.