“Clinical surrogate end-points”

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Abstract

This presentation reflected a personal opinion about the role ofsurrogates as clinical end-points. According to the BiomarkersDefinitions Working Group, a surrogate is ‘a biomarker that isintended to substitute for a clinical end-point and is expectedto predict clinical benefit (or harm or lack of clinical benefit) basedon epidemiologic, therapeutic, pathophysiologic or other scientificevidence’.1 Although overall survival is the gold standardrecognised by both the European Medicines Agency (EMEA) andthe US Food and Drug Administration (FDA) as a basis for conditional(EMEA) or accelerated (FDA) approval of new anticanceragents, surrogate end-points are often considered to be reasonablylikely to predict clinical benefit.
Lingua originaleUndefined/Unknown
pagine (da-a)44-45
RivistaEuropean Journal of Cancer
Volumen.9
Stato di pubblicazionePublished - 2007

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