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

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberCHMP/27994/2008 Rev. 1
Published11/01/2013
Effective from01/07/2013
KeywordsCancer, malignancy, biomarker, targeted drugs, pharmacogenomics
DescriptionThis 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.


Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/07/2013–present


Published: 22/12/2011

First version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/08/2008–30/06/2013


Published: 27/07/2006

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