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.

PALMERI S (2007). “Clinical surrogate end-points”. EUROPEAN JOURNAL OF CANCER, n.9, 44-45 [10.1016/j.ejcsup.2007.09.026].

“Clinical surrogate end-points”

PALMERI, Sergio
2007-01-01

Abstract

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.
2007
PALMERI S (2007). “Clinical surrogate end-points”. EUROPEAN JOURNAL OF CANCER, n.9, 44-45 [10.1016/j.ejcsup.2007.09.026].
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10447/15714
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? 1
social impact