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

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

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. …