Fleming T R, Prentice R L, Pepe M S, Glidden D
Department of Biostatistics, University of Washington, Seattle 98195.
Stat Med. 1994 May 15;13(9):955-68. doi: 10.1002/sim.4780130906.
Surrogate endpoints have been defined by Prentice as response variables that can substitute for a 'true' endpoint for the purpose of comparing specific interventions or treatments in a clinical trial. The applicability of this definition, and of related surrogate endpoint criteria, is discussed, with emphasis on cancer and AIDS research settings. Auxiliary endpoints are defined as response variables, or covariates, that can strengthen true endpoint analyses. Specifically, such response variables provide some additional information on true endpoint occurrence times for study subjects having censored values for such times. Auxiliary variables will very frequently be available, and they may be able to be used without making additional strong assumptions. Approaches to the use of auxiliary variables using ideas based on augmented score and augmented likelihood methods are described.
普伦蒂斯将替代终点定义为在临床试验中可替代“真实”终点以比较特定干预措施或治疗方法的反应变量。本文讨论了该定义及相关替代终点标准的适用性，重点关注癌症和艾滋病研究领域。辅助终点被定义为可加强真实终点分析的反应变量或协变量。具体而言，此类反应变量为真实终点发生时间被截尾的研究对象提供了关于真实终点发生时间的一些额外信息。辅助变量通常很容易获得，并且在无需做出额外强假设的情况下即可使用。本文描述了基于增强得分和增强似然方法使用辅助变量的方法。
