Surrogate endpoints: do they really contribute in therapeutic decision making?

Abstract

Surrogate endpoints are substitutes for the true endpoints and measured in any clinical research to relate in some way to the outcome of primary interest. Inappropriate selection of surrogate markers may lead to controversies during clinical trials or therapeutic interventions. Use of surrogate markers depends upon thorough understanding of the pathophysiology of the disease and pharmacology of drugs. Results obtained with surrogates should be regarded as preliminary and necessitates definitive studies.