“Clinical surrogate end-points”

This presentation reflected a personal opinion about the role of surrogates as clinical end-points. According to the Biomarkers Definitions Working Group, a surrogate is ‘a biomarker that is intended to substitute for a clinical end-point and is expected to predict clinical benefit (or harm or lack of clinical benefit) based on epidemiologic, therapeutic, pathophysiologic or other scientific evidence’.1 Although overall survival is the gold standard recognised by both the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) as a basis for conditional (EMEA) or accelerated (FDA) approval of new anticancer agents, surrogate end-points are often considered to be reasonably likely to predict clinical benefit.