Simple Methods for Evaluating 4 Types of Biomarkers: Surrogate Endpoint, Prognostic, Predictive, and Cancer Screening

被引：6

作者：

Baker, Stuart G. ^{[1
]}

Kramer, Barnett S. ^{[1
]}

机构：

[1] NCI, Biometry Res Grp, Div Canc Prevent, Bethesda, MD 20892 USA

来源：

BIOMARKER INSIGHTS | 2020年 / 15卷

关键词：

Decision curve; net benefit; relative utility curve; risk prediction; risk-based decision-making; CLINICAL-TRIALS; MODEL; VALIDATION; CONFIDENCE; SUBSETS; CURVES; MARKER;

D O I：

10.1177/1177271920946715

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

We review simple methods for evaluating 4 types of biomarkers. First, we discuss the evaluation of surrogate endpoint biomarkers (to shorten a randomized trial) using 2 statistical and 3 biological criteria. Second, we discuss the evaluation of prognostic biomarkers (to predict the risk of disease) by comparing data collection costs with the anticipated net benefit of risk prediction. Third, we discuss the evaluation of predictive markers (to search for a promising subgroup in a randomized trial) using a multivariate subpopulation treatment effect pattern plot involving a risk difference or responders-only benefit function. Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.

引用

页数：8

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