How can biomarkers become surrogate endpoints?

European Journal of Cancer, Supplement - Tập 5 - Trang 37-40 - 2007
B. Berns1, P. Démolis2, M.E. Scheulen3
1Clinical Haematology & Oncology, Centocor Ltd., 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, UK
2Assesment Anticancer Drugs, AFSSaPS, Saint Denis 143, 147 Boulevard Anatole France, F-93285 Saint-Denis Cedex, Paris, France
3Innere Klinik und Poliklinik (Tumorforschung), Westdeutsches Tumorzentrum, Universitätsklinikum Essen, Hufelandstraße 55, D-45122 Essen, Germany

Tài liệu tham khảo

Biomarkers Definitions Working Group, 2001, Biomarkers and surrogate endpoints: preferred definitions and conceptual framework, Clin Pharmacol Ther, 69, 89, 10.1067/mcp.2001.113989 Downing, 2000 European Medicines Agency (EMEA). Report on the EMEA/CHMP biomarkers workshop. 16 Feb, London, UK: EMEA; 2006. <http://www.emea.europa.eu/pdfs/human/biomarkers/42720905en.pdf>. Temple, 2000, Defining surrogate endpoints and biomarkers for drug action in trials with pediatric subjects, 64 57 Federal Register 1992;13234–42. Zwierzina, 2004, Is cancer research missing an opportunity? A call for cooperation, Cancer Futures, 3, 87 European Medicines Agency (EMEA). Guideline on clinical trials in small populations. London, UK. 2006. http://www.emea.europa.eu/pdfs/human/ewp/8356105en.pdf>.
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European Journal of Cancer, Supplement

Tập 5

37-40

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