1,306
Views
10
CrossRef citations to date
0
Altmetric
Original Articles

Missing Data and Censoring in the Analysis of Progression-Free Survival in Oncology Clinical Trials

, , &
Pages 951-970 | Received 17 Feb 2011, Accepted 19 Oct 2011, Published online: 19 Aug 2013

REFERENCES

  • Amit , O. , Mannino , F. , et al. ( 2011 ). Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis . European Journal of Cancer. 47 : 1772 – 1778 .
  • Carroll , K. J. ( 2007 ). Analysis of progression free survival in oncology trials: Some common statistical issues . Pharmaceutical Statististics 6 : 99 – 111 .
  • Chakravarty , A. , Sridhara , R. ( 2008 ). Use of progression-free survival as a surrogate marker in oncology trials: Some regulatory issues . Statistical Methods in Medical Research 17 : 515 – 518 .
  • CHMP (2012a). EMA/CHMP/205/95/Rev.4. Guideline on the evaluation of anticancer medicinal products in man. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137128.pdf
  • CHMP (2012b). EMA/CHMP/27994/2008/Rev.1. Methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137126.pdf
  • CNSTAT (Committee on National Statistics) . ( 2010 ). The Prevention and Treatment of Missing Data in Clinical Trials . National Academies Press. Available at : http://www. nap.edu/openbook.php?record_id=12955&page=1 .
  • Collett , D. ( 1994 ). Modelling Survival Data in Medical Research . London , UK : Chapman & Hall .
  • Dancey , J. E. , Dodd , L. E. , Ford , R. , Kaplan , R. , Mooney , M. , Rubinstein , L. , Schwartz , L. H. , Shankar , L. , Therasse , P. ( 2009 ). Recommendations for the assessment of progression in randomised cancer treatment trials . European Journal of Cancer 45 : 281 – 289 .
  • Di Rienzo , A. G. ( 2003 ). Non parametric comparison of two survival-time distributions in the presence of dependent censoring . Biometrics 59 : 497 – 504 .
  • Dodd , L. E. , Korn , E. L. , et al. ( 2008 ). Blinded independent central review of progression-free-survival in Phase III clinical trials: Important design element or unnecessary expense? Journal of Clinical Oncology 26 : 3791 – 3796 .
  • Finkelstein , D. M. ( 1986 ). A proportional hazards model for interval-censored failure time data . Biometrics 42 : 845 – 854 .
  • Fleming , T. R. , Rothmann , M. D. , Lu , H. L. ( 2009 ). Issues when using progression-free-survival when evaluating oncology products . Journal of Clinical Oncology 27 : 2874 – 2880 .
  • Flyer , P. , Hirman , J. ( 2009 ). Missing data in confirmatory clinical trials . Journal of Biopharmaceutical Statistics 19 : 969 – 979 .
  • 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 .
  • Freidlin , B. , Kom , E. L. ( 2005 ). Testing treatment effects in the presence of competing risks . Statistics in Medicine 24 : 1703 – 1712 .
  • Hertz-Picciotto , I. , Rockhill , B. ( 1997 ). Validity and efficiency of approximation methods for tied survival times in Cox regression . Biometrics 53 : 1151 – 1156 .
  • Huang , X. , Zhang , N. ( 2008 ). Regression survival analysis with an assumed copula for dependent censoring: A sensitivity analysis approach . Biometrics 64 : 1 – 10 .
  • Johnson , J. R. , Williams , G. , Pazdur , R. ( 2003 ). End points and United States Food and Drug Administration approval of oncology drugs . Journal of Clinical Oncology 21 : 1404 – 1411 .
  • Lee , S. Y. , Wolfe , R. A. ( 1998 ). A simple test for independent censoring under the proportional hazards model . Biometrics 54 : 1176 – 1182 .
  • Montgomery , D. C. , Peck , E. A. ( 1992 ). Introduction to Linear Regression Analysis . New York , NY : John Wiley & Sons .
  • Prentice , R. L. , Gloeckler , L. A. ( 1978 ). Regression analysis of grouped survival data with application to breast cancer data . Biometrics 34 : 57 – 67 .
  • Rothmann , M. , Kati , K. , Lee , K. Y. ( 2009 ). Examining the extent and impact of missing data in oncology clinical trials . Proceedings of the Joint Statistical Meetings 2009 : 4014 – 4019 .
  • Ruan , P. K. , Gray , R. J. ( 2008 ). Sensitivity analysis of progression free survival with dependent withdrawal . Statistics in Medicine 27 : 1180 – 1198 .
  • Stone , A. M. , Bushnell , W. , Denne , J. , Sargent , D. J. , Amit , O. , Chen , C. , Bailey-Iacona , 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.
  • Stone , A. M. , Wheeler , C. , Carroll , K. , Barge , A. ( 2007 ). Optimizing randomised Phase II trials assessing tumour progression . Contemporary Clinical Trials 28 : 146 – 152 .
  • Sun , X. , Chen , C. ( 2010 ). Comparison of Finkelstein's method with the conventional approach for interval-censored data analysis . Statistics in Biopharmaceutical Research 2 : 97 – 108 .
  • Williams , G. , He , K. , Chen , G. , Chi , G. , Pazdur , R. ( 2002 ). Operational bias in assessing time to progression (TTP). Proceedings of the American Society of Clinical Oncology 2002; abstract 975 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.