Evaluating a surrogate endpoint at three levels, with application to vaccine development.
Evaluating a surrogate endpoint at three levels, with application to vaccine development.
复制标题
在三个级别上评估替代端点，并应用于疫苗开发。
DOI：
10.1002/sim.3122
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发表时间：
2008-10-15
影响因子：
2
通讯作者：
Self, Steven G.
中科院分区：
文献类型：
--
作者：
Gilbert, Peter B.;Qin, Li;Self, Steven G.
关键词：
Identification of an immune response to vaccination that reliably predicts protection from clinically significant infection, i.e. an immunological surrogate endpoint, is a primary goal of vaccine research. Using this problem of evaluating an immunological surrogate as an illustration, we describe a hierarchy of three criteria for a valid surrogate endpoint and statistical analysis frameworks for evaluating them. Based on a placebo-controlled vaccine efficacy trial, the first level entails assessing the correlation of an immune response with a study endpoint in the study groups, and the second level entails evaluating an immune response as a surrogate for the study endpoint that can be used for predicting vaccine efficacy for a setting similar to that of the vaccine trial. We show that baseline covariates, innovative study design, and a potential outcomes formulation can be helpful for this assessment. The third level entails validation of a surrogate endpoint via meta-analysis, where the goal is to evaluate how well the immune response can be used to predict vaccine efficacy for new settings (building bridges). A simulated vaccine trial and two example vaccine trials are presented, one supporting that certain anti-influenza antibody levels are an excellent surrogate for influenza illness and another supporting that certain anti-HIV antibody levels are not useful as a surrogate for HIV infection.
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影响因子：
2
作者：
Chan, ISF;Li, S;Heyse, J
通讯作者：
Heyse, J
影响因子：
3.8
作者：
ENNIS, FA;QI, YH;SCHILD, GC
通讯作者：
SCHILD, GC
影响因子：
1.9
作者：
Frangakis, CE;Rubin, DB
通讯作者：
Rubin, DB
DOI：
10.1198/016214505000000970
发表时间：
2006-03-01
影响因子：
3.7
作者：
Hudgens, MG;Halloran, ME
通讯作者：
Halloran, ME
影响因子：
1.9
作者：
Follmann, Dean
通讯作者：
Follmann, Dean