Statistical Methods for Evaluation of Biomarkers

在过去的一年里，该项目的研究人员和工作人员开发了非参数序贯方法来评估诊断生物标志物。他们研究了选择最佳诊断生物标志物的两阶段程序，以控制错误选择的概率。在对生物标志物的敏感性和特异性进行分组序贯评价后，开发了二元诊断生物标志物准确性的点和区间估计方法。对于其测量值受检测限影响的生物标志物，该小组开发了最大似然比检验，用于比较受检测限影响的生物标志物的区分能力。为了设计比较诊断准确性研究，开发了一种自适应方法，以保持由于滋扰参数的错误指定而导致的研究功效。

In the past year investigators and staff on this project developed nonparametric sequential methods for evaluation of diagnostic biomarkers. They investigated a two-stage procedures for selecting the best diagnostic biomarkers to control the probability of incorrect selection. Methods for point and interval estimation of accuracies of a binary diagnostic biomarkers were developed following group sequential evaluation of the biomarkers' sensitivity and specificity. For biomarkers whose measurements are subject to limits of detection, the group developed maximum likelihood ratio tests for comparing the discriminatory ability of biomarkers subject to limit of detection. To design comparative diagnostic accuracy studies an adaptive approach was developed to maintain the study power due to misspecifications of nuisance parameters.