Guideline on the evaluation of anticancer medicinal products in man; 2006. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017748.
Guidance for industry, clinical trial endpoints for the approval of cancer drugs and biologics; 2007. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf.
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Guideline on the evaluation of anticancer medicinal products in man; 2006. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017748.
Guidance for industry, clinical trial endpoints for the approval of cancer drugs and biologics; 2007. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf.
- New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).Eur J Cancer. 2009; 45: 228-247
- Progression-free survival remains debatable endpoint in cancer trials.J Natl Cancer Inst. 2009; 101: 1439-1441
- Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group.Eur J Cancer. 2011;
- Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis.Eur J Cancer. 2011;
- Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?.J Clin Oncol. 2008; 26: 3791-3796
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 trials for registration; 2008. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500017749.
- Interval censoring.Stat Methods Med Res. 2010; 19: 53-70