A unified procedure for meta-analytic evaluation of surrogate end points in randomized clinical trials

Posted by National Health Index Clinical Trial News Tuesday, April 3rd, 2012

Biostatistics.oxfordjournals.org: March 6th, 2012.

The meta-analytic approach to evaluating surrogate end points assesses the predictiveness of treatment effect on the surrogate toward treatment effect on the clinical end point based on multiple clinical trials. Definition and estimation of the correlation of treatment effects were developed in linear mixed models and later extended to binary or failure time outcomes on a case-by-case basis. In a general regression setting that covers nonnormal outcomes, we discuss in this paper several metrics that are useful in the meta-analytic evaluation of surrogacy. We propose a unified 3-step procedure to assess these metrics in settings with binary end points, time-to-event outcomes, or repeated measures.  Read More