Five criteria for using a surrogate endpoint to predict treatment effect based on data from multiple previous trials.

ABSTRACT: A surrogate endpoint in a randomized clinical trial is an endpoint that occurs after randomization and before the true, clinically meaningful, endpoint that yields conclusions about the effect of treatment on true endpoint. A surrogate endpoint can accelerate the evaluation of new treatments but at the risk of misleading conclusions. Therefore, criteria are needed for deciding whether to use a surrogate endpoint in a new trial. For the meta-analytic setting of multiple previous trials, each with the same pair of surrogate and true endpoints, this article formulates 5 criteria for using a surrogate endpoint in a new trial to predict the effect of treatment on the true endpoint in the new trial. The first 2 criteria, which are easily computed from a zero-intercept linear random effects model

SUBMITTER: Baker SG 

PROVIDER: S-EPMC5771803 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature