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Volumn 19, Issue 10, 2013, Pages 2613-2620

Missing data and measurement variability in assessing progression-free survival endpoint in randomized clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; LAPATINIB;

EID: 84878070728     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-2938     Document Type: Article
Times cited : (34)

References (24)
  • 1
    • 77649244511 scopus 로고    scopus 로고
    • Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007
    • Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, et al. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst 2010;102:230-43.
    • (2010) J Natl Cancer Inst , vol.102 , pp. 230-243
    • Sridhara, R.1    Johnson, J.R.2    Justice, R.3    Keegan, P.4    Chakravarty, A.5
  • 3
    • 84878090287 scopus 로고    scopus 로고
    • The imaging viewpoint: How imaging affects determination of progression-free survival
    • Sullivan DC, Schwartz LH, Zhao B. The imaging viewpoint: how imaging affects determination of progression-free survival. Clin Cancer Res 2013;19:2621-8.
    • (2013) Clin Cancer Res , vol.19 , pp. 2621-2628
    • Sullivan, D.C.1    Schwartz, L.H.2    Zhao, B.3
  • 4
    • 49249111441 scopus 로고    scopus 로고
    • Blinded independent central review of progression-free survival in phase III clinical trials: Important design element or unnecessary expense?
    • Dodd LE, Korn EL, Freidlin B, Jaffe CC, Rubinstein LV, Dancey J, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008;26:3791-6.
    • (2008) J Clin Oncol , vol.26 , pp. 3791-3796
    • Dodd, L.E.1    Korn, E.L.2    Freidlin, B.3    Jaffe, C.C.4    Rubinstein, L.V.5    Dancey, J.6
  • 5
    • 78650359532 scopus 로고    scopus 로고
    • Measurement error in the timing of events: Effect on survival analyses in randomized clinical trials
    • Korn EL, Dodd LE, Freidlin B. Measurement error in the timing of events: effect on survival analyses in randomized clinical trials. Clin Trials 2010;7:626-33.
    • (2010) Clin Trials , vol.7 , pp. 626-633
    • Korn, E.L.1    Dodd, L.E.2    Freidlin, B.3
  • 8
    • 21744452231 scopus 로고    scopus 로고
    • A hybrid algorithm for computation of the nonparametric maximum likelihood estimator from censored data
    • Wellner JA, Zhan Y. A hybrid algorithm for computation of the nonparametric maximum likelihood estimator from censored data. J Am Stat Assoc 1997;92:945-59.
    • (1997) J Am Stat Assoc , vol.92 , pp. 945-959
    • Wellner, J.A.1    Zhan, Y.2
  • 9
    • 84867864337 scopus 로고    scopus 로고
    • Impact of disease progression date determination on progression-free survival estimates in advanced lung cancer
    • Qi Y, Allen Ziegler KL, Hillman SL, Redman MW, Schild SE, Gandara DR, et al. Impact of disease progression date determination on progression-free survival estimates in advanced lung cancer. Cancer 2012;118:5358-65.
    • (2012) Cancer , vol.118 , pp. 5358-5365
    • Qi, Y.1    Allen Ziegler, K.L.2    Hillman, S.L.3    Redman, M.W.4    Schild, S.E.5    Gandara, D.R.6
  • 10
    • 80051550977 scopus 로고    scopus 로고
    • Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group
    • Stone Am, Bushnell W, Denne J, Sargent DJ, Amit O, et al. Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group. Eur J Cancer 2011;47:1763-71.
    • (2011) Eur J Cancer , vol.47 , pp. 1763-1771
    • Stone, A.1    Bushnell, W.2    Denne, J.3    Sargent, D.J.4    Amit, O.5
  • 11
    • 14644420151 scopus 로고    scopus 로고
    • Generalized log-rank tests for interval-censored failure time data
    • Sun J, Zhao Q, Zhao X. Generalized log-rank tests for interval-censored failure time data. Scandinavian J Stat 2005;32:49-57.
    • (2005) Scandinavian J Stat , vol.32 , pp. 49-57
    • Sun, J.1    Zhao, Q.2    Zhao, X.3
  • 12
    • 79952576381 scopus 로고    scopus 로고
    • The prevention and treatment of missing data in clinical trials
    • National Research Council. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press
    • National Research Council. The prevention and treatment of missing data in clinical trials. Panel on handling missing data in clinical trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press; 2010.
    • (2010) Panel on Handling Missing Data in Clinical Trials
  • 13
    • 84878036665 scopus 로고    scopus 로고
    • Section 14.1
    • Lapatinib product label, Section 14.1. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/022059s013lbl.pdf
    • Lapatinib Product Label
  • 14
    • 84860671874 scopus 로고    scopus 로고
    • Discordance between BICR readers
    • Borradaile K, Ford R, O'Neal M, Byme K. Discordance between BICR readers. Applied Clin Trials 2010. Available from: http://www. appliedclinicaltrialsonline.com/appliedclinicaltrials/Labs/Discordance-Between- BICR-Readers/ArticleStandard/Article/detail/693554
    • (2010) Applied Clin Trials
    • Borradaile, K.1    Ford, R.2    O'Neal, M.3    Byme, K.4
  • 15
    • 80051550048 scopus 로고    scopus 로고
    • Blinded independent central review of progression in cancer clinical trials: Results from a meta-analysis
    • Amit O, Mannino F, Stone AM, Bushnell W, Denne J, Helterbrand J, et al. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur J Cancer 2011;47: 1772-8.
    • (2011) Eur J Cancer , vol.47 , pp. 1772-1778
    • Amit, O.1    Mannino, F.2    Stone, A.M.3    Bushnell, W.4    Denne, J.5    Helterbrand, J.6
  • 16
    • 84877630674 scopus 로고    scopus 로고
    • Evaluation of blinded independent central review of tumor progression in oncology clinical trials: A meta-analysis
    • Zhang JJ, Chen H, He K, Tang S, Justice R, Keegan P, et al. Evaluation of blinded independent central review of tumor progression in oncology clinical trials: a meta-analysis. Drug Inf J 2013;47:167-74.
    • (2013) Drug Inf J , vol.47 , pp. 167-174
    • Zhang, J.J.1    Chen, H.2    He, K.3    Tang, S.4    Justice, R.5    Keegan, P.6
  • 17
    • 84878099564 scopus 로고    scopus 로고
    • Oncologic Drug Advisory Committee. July 24
    • Oncologic Drug Advisory Committee. July 24, 2012 Meeting. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeeting-Materials/Drugs/ OncologicDrugsAdvisoryCommittee/ucm285400. htm
    • (2012) Meeting
  • 18
    • 84878031625 scopus 로고    scopus 로고
    • Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials
    • Zhang JJ, Zhang L, Chen H, Murgo AJ, Dodd LE, Pazdur R, et al. Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials. Clin Cancer Res 2013;19:2637-45.
    • (2013) Clin Cancer Res , vol.19 , pp. 2637-2645
    • Zhang, J.J.1    Zhang, L.2    Chen, H.3    Murgo, A.J.4    Dodd, L.E.5    Pazdur, R.6
  • 20
    • 84866428422 scopus 로고    scopus 로고
    • Attenuation of treatment effect due to measurement variability in assessment of progression-free survival
    • Hong S, Schmitt N, Stone A, Denne J. Attenuation of treatment effect due to measurement variability in assessment of progression-free survival. Pharm Statistics; 11:394-402.
    • Pharm Statistics , vol.11 , pp. 394-402
    • Hong, S.1    Schmitt, N.2    Stone, A.3    Denne, J.4
  • 22
    • 79959280313 scopus 로고    scopus 로고
    • Overall survival as the outcome for randomized clinical trials with effective subsequent therapies
    • Korn EL, Freidlin B, Abrams JS. Overall survival as the outcome for randomized clinical trials with effective subsequent therapies. J Clin Oncol 2011;29:2439-42.
    • (2011) J Clin Oncol , vol.29 , pp. 2439-2442
    • Korn, E.L.1    Freidlin, B.2    Abrams, J.S.3
  • 23
    • 73349111952 scopus 로고    scopus 로고
    • Role of sensitivity analyses in assessing progression-free survival in late-stage oncology trials
    • Bhattacharya S, Fyfe G, Gray RJ, Sargent DJ. Role of sensitivity analyses in assessing progression-free survival in late-stage oncology trials. J Clin Oncol 2009:27:5958-64.
    • (2009) J Clin Oncol , vol.27 , pp. 5958-5964
    • Bhattacharya, S.1    Fyfe, G.2    Gray, R.J.3    Sargent, D.J.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.