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Editorials

Research Outcomes and Recommendations for the Assessment of Progression in Cancer Clinical Trials

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Pages 949-950 | Published online: 19 Aug 2013

REFERENCES

  • Amit , O. , Mannino , F. , Stone , A. M. , Bushnell , W. , Denne , J. , Helterbrand , J. , Burger , H. U. ( 2011 ). Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis and recommendations from a PhRMA working group . European Journal of Cancer 47 : 1772 – 1778 .
  • CHMP . ( 2008 ). EMEA/CHMP/EWP/27994/2008. Methodological considerations for using progression-free survival (PFS) as primary endpoint in confirmatory trials for registration. Available at: http://www.emea.europa.eu/pdfs/human/ewp/2799408en.pdf
  • Food and Drug Administration. ( 2007 ). FDA Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics . Available at : http://www. fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm071590.pdf, accessed May 2007 .
  • Stone , A. M. , Bushnell , W. , Denne , J. , Sargent , D. J. , Amit , O. , Chen , C. , Bailey-lacona , R. , Helterbrand , J. , Williams , G. ( 2011 ). Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group . European Journal of Cancer 47 : 1763 – 1771 .
  • Sun , X. , Chen , C. ( 2010 ). Comparison of Finkelstein's method with the conventional approach for interval-censored data analysis . Statistics in Biopharmaceutical Research 2 ( 1 ): 97 – 108 .

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