Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man - methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials - Scientific guideline
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This document is an appendix to the guideline on the evaluation of anticancer medicinal products in man. It provides a guidance on the use of progression-free survival or disease-free survival as endpoint in clinical efficacy trials.
Keywords: Cancer, malignancy, biomarker, targeted drugs, pharmacogenomics
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Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man (CHMP/EWP/205/95 REV. 3), methodological considerations for using Progression-Free Survival (PFS) as primary endpoint in confirmatory ... (PDF/40.63 KB)
Adopted
First published: 24/01/2008
Last updated: 24/01/2008
Legal effective date: 01/08/2008
EMEA/CHMP/EWP/27994/2008 -
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Draft appendix 1 to the guideline on the evaluation of anticancer medicinal products in man (CHMP/EWP/205/95 rev. 3), methodological considerations for using Progression-Free Survival (PFS) as primary endpoint in confirm... (PDF/35.9 KB)
Draft: consultation closed
First published: 27/07/2006
Last updated: 27/07/2006
EMEA/CHMP/EWP/267575/2006/Corr.