Prentice's approach and the meta-analytic paradigm: A reflection on the role of statistics in the evaluation of surrogate endpoints
Prentice's approach and the meta-analytic paradigm: A reflection on the role of statistics in the evaluation of surrogate endpoints
复制标题
DOI：
10.1111/j.0006-341x.2004.00222.x
复制
发表时间：
2004-09-01
期刊：
影响因子：
1.9
通讯作者：
Buyse, M
中科院分区：
文献类型：
--
作者：
Alonso, A;Molenberghs, G;Buyse, M
我们对替代终点评价的统计方法的优势和局限性进行了展望。尽管使用多项试验克服了单项试验框架的一些局限性（普伦蒂斯，1989，《医学统计学》8，431-440），但可以说，替代终点的评价永远不能仅使用统计学证据，但此类证据应被视为决策过程中的一个组成部分，其中涉及许多临床和生物学考虑因素。我们简要地提出了一个分层的框架，结合普伦蒂斯的工作的想法，是统一适用于不同类型的替代和真正的临床结果。
We put a perspective on the strengths and limitations of statistical methods for the evaluation of surrogate endpoints. Whereas using several trials overcomes some of the limitations of a single-trial framework (Prentice, 1989, Statistics in Medicine 8, 431-440), arguably the evaluation of surrogate endpoints can never be done using only statistical evidence but such evidence should be seen as but one component in a decision-making process that involves, among others, a number of clinical and biological considerations. We briefly present a hierarchical framework that incorporates ideas from Prentice's work and is uniformly applicable to different types of surrogate and true clinical outcomes.