How can biomarkers become surrogate endpoints?

European Journal of Cancer, Supplement

Volumn 5, Issue 9, 2007, Pages 37-40

  Berns, B ^a   Demolis P ^b   Scheulen, M E ^c  

^a Centocor Ltd   (United Kingdom)

^b AFSSaPS Saint Denis   (France)

^c UNIVERSITY HOSPITAL ESSEN   (Germany)

Author keywords

Biomarker; Drug approval; Drug registration; Endpoint; Surrogate; Targeted agents

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CANCER RESEARCH; CLINICAL RESEARCH; DRUG APPROVAL; DRUG INDUSTRY; DRUG TARGETING; HEALTH CARE; HUMAN; PHARMACEUTICAL CARE; PRIORITY JOURNAL;

EID: 36549000244     PISSN: 13596349     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejcsup.2007.09.003     Document Type: Article

References (7)

1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69 (2001) 89-95.
2. Downing G.J. Biomarkers and surrogate endpoints: clinical research and applications (2000), Elsevier Scientific, Amsterdam p. 1-7
3. European Medicines Agency (EMEA). Report on the EMEA/CHMP biomarkers workshop. 16 Feb, London, UK: EMEA; 2006. .
4. Temple R. Defining surrogate endpoints and biomarkers for drug action in trials with pediatric subjects. In: Yaffe S. (Ed). Rational therapeutics for infants and children: workshop summary (2000), National Academy Press, Washington (DC) 64.
5. 57 Federal Register 1992;13234-42.
6. Zwierzina H., and Ellis M. Is cancer research missing an opportunity? A call for cooperation. Cancer Futures 3 (2004) 87-88.
7. European Medicines Agency (EMEA). Guideline on clinical trials in small populations. London, UK. 2006. http://www.emea.europa.eu/pdfs/human/ewp/8356105en.pdf>.