期刊
STATISTICS IN MEDICINE
卷 27, 期 23, 页码 4758-4778出版社
JOHN WILEY & SONS LTD
DOI: 10.1002/sim.3122
关键词
clinical trial; counterfactual; immune correlate; meta-analysis; potential outcomes; principal surrogate; statistical surrogate
类别
资金
- NIAID NIH HHS [2 R01 AI54165-04, R37 AI029168, R01 AI054165-05, R01 AI054165] Funding Source: Medline
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 its 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 its 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 I 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. Copyright (C) 2007 John Wiley & Sons. Ltd.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据