CE_23C: Methods to Evaluate Surrogate Markers (Added Fee)

Novel biomarkers have great potential to dramatically change the decision making process of modern medicine. Recently there has been increased interest in using markers as a surrogate for assessing a treatment effect, for diagnosing disease or for predicting the risk of future clinical events. In the first part of the short course, we will introduce robust measures to assess the value of a potential surrogate marker. We will discuss the estimation procedure, inference, advantages over previously proposed model-dependent approaches, and use of these measures to identify valid surrogate markers in settings with both censored and noncensored primary outcomes. In the second part of the course, we will present, discuss, and illustrate methods to evaluate multiple surrogate markers. We will discuss existing methods, a two-stage extension from the single marker setting (Part 1), and an approach to identify and evaluate the optimal combination of the markers where optimality is defined with respect to the ability to predict the treatment effect on the primary outcome. Lastly, Part 3 will briefly cover two additional topics 1) using a surrogate marker to test for a treatment effect in a future study, and 2) testing for heterogeneity in the utility of a surrogate marker, both will be presented via an application to a diabetes clinical study.