Abstract
This article discusses statistical approaches to the validation of surrogate biomarkers and endpoints. One approach that has been successfully used in oncology consists of estimating associations at two levels: the association between the surrogate and the clinical endpoint, called the individual-level association, and the association between the effects of treatment on the surrogate and the clinical endpoint, called the trial-level association. This approach requires data to be available from multiple randomized trials, such as in a meta-analysis of trials based on individual patient data. The approach is illustrated using randomized trials of first-line treatments for advanced tumors of the colon, breast, ovary, and prostate. Data from several meta-analyses suggest that progression-free survival is an acceptable surrogate in advanced colorectal and ovarian cancer, but not in breast and prostate cancer.
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