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Volumn 38, Issue 4, 2011, Pages 598-604

Statistical considerations for the next generation of clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; BIOLOGICAL MARKER; CETUXIMAB; CISPLATIN; CYTOTOXIC AGENT; FLUOROPYRIMIDINE; FLUOROURACIL; GEMCITABINE; OXALIPLATIN; SORAFENIB;

EID: 79961006796     PISSN: 00937754     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.seminoncol.2011.05.014     Document Type: Article
Times cited : (10)

References (38)
  • 5
    • 33845382806 scopus 로고
    • Non parametric estimation from incomplete observations
    • Kaplan EL, Meier P. Non parametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-81.
    • (1958) J Am Stat Assoc , vol.53 , pp. 457-481
    • Kaplan, E.L.1    Meier, P.2
  • 6
    • 0013886333 scopus 로고
    • Evaluation of survival data and two new rank order statistics arising in its consideration
    • Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep. 1966;50:163-70.
    • (1966) Cancer Chemother Rep , vol.50 , pp. 163-170
    • Mantel, N.1
  • 7
    • 37549040613 scopus 로고    scopus 로고
    • Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer
    • Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357:2666-76.
    • (2007) N Engl J Med , vol.357 , pp. 2666-2676
    • Miller, K.1    Wang, M.2    Gralow, J.3
  • 10
    • 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, 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;26:3791-96.
    • (2008) J Clin Oncol , vol.26 , pp. 3791-3796
    • Dodd, L.E.1    Korn, E.L.2    Freidlin, B.3
  • 11
    • 42949149159 scopus 로고    scopus 로고
    • Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: A randomized phase III study
    • Saltz LB, Clarke S, Diaz-Rubio E, et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008;26:2013-19.
    • (2008) J Clin Oncol , vol.26 , pp. 2013-2019
    • Saltz, L.B.1    Clarke, S.2    Diaz-Rubio, E.3
  • 12
    • 73349111952 scopus 로고    scopus 로고
    • Role of sensitivity analysis in assessing progression-free survival in late-stage oncology trials
    • Bhattacharya S, Fyfe G, Gray RJ, Sargent DJ. Role of sensitivity analysis 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
  • 13
    • 71549143528 scopus 로고    scopus 로고
    • Detecting an overall survival benefit that is derived from progression-free survival
    • Brogilo KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst. 2009;101:1642-9.
    • (2009) J Natl Cancer Inst , vol.101 , pp. 1642-1649
    • Brogilo, K.R.1    Berry, D.A.2
  • 14
    • 68949094312 scopus 로고    scopus 로고
    • Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy
    • Kopetz S, Chang GJ, Overman MJ, et al. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin. Oncol. 2009;27:3677-83.
    • (2009) J Clin. Oncol , vol.27 , pp. 3677-3683
    • Kopetz, S.1    Chang, G.J.2    Overman, M.J.3
  • 15
    • 0035100888 scopus 로고    scopus 로고
    • Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
    • Biomarkers Definitions Working Group
    • Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89-95.
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 89-95
  • 16
    • 65349191398 scopus 로고    scopus 로고
    • Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials
    • Shi Q, Sargent DJ. Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials. Int J Clin Oncol. 2009;14:102-111.
    • (2009) Int J Clin Oncol , vol.14 , pp. 102-111
    • Shi, Q.1    Sargent, D.J.2
  • 19
    • 42949145995 scopus 로고    scopus 로고
    • Evaluation of tumor response, disease control, progressionfree survival, and time to progression as potential surrogate endpoints in metastatic breast cancer
    • Burzykowski T, Buyse M, Piccart-Gehart MJ, et al. Evaluation of tumor response, disease control, progressionfree survival, and time to progression as potential surrogate endpoints in metastatic breast cancer. J Clin Oncol. 2008;26:1987-92.
    • (2008) J Clin Oncol , vol.26 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gehart, M.J.3
  • 20
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate endpoints in clinical trials: Are we being misled?
    • Fleming TR, DeMets DL. Surrogate endpoints in clinical trials: are we being misled? Ann Intern Med. 1996;125:605-13.
    • (1996) Ann Intern Med , vol.125 , pp. 605-613
    • Fleming, T.R.1    DeMets, D.L.2
  • 21
    • 17644412369 scopus 로고    scopus 로고
    • Surrogate end points in clinical research: Hazardous to your health
    • DOI 10.1097/01.AOG.0000157445.67309.19
    • Grimes DA, Schulz KF. Surrogate endpoints in clinical research: hazardous to your health. Obstet Gynecol. 2005;105:1114-18. (Pubitemid 40571032)
    • (2005) Obstetrics and Gynecology , vol.105 , Issue.5 I , pp. 1114-1118
    • Grimes, D.A.1    Schulz, K.F.2
  • 23
    • 79953674770 scopus 로고    scopus 로고
    • Two or three year disease free survival (DFS) as a primary endpoint in stage III adjuvant colon cancer trails with fluoropyrimidines with or without oxaliplatin or irinotecan: Data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07, and C89803
    • Adjuvant Colon Cancer Endpoints (ACCENT) Group In press
    • Sargent DJ, Shi Q, Yothers G, et al. Adjuvant Colon Cancer Endpoints (ACCENT) Group. Two or three year disease free survival (DFS) as a primary endpoint in stage III adjuvant colon cancer trails with fluoropyrimidines with or without oxaliplatin or irinotecan: data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07, and C89803. Eur J Cancer. In press.
    • Eur J Cancer
    • Sargent, D.J.1    Shi, Q.2    Yothers, G.3
  • 25
    • 0025148278 scopus 로고
    • Continual reassessment method: A practical design for phase 1 clinical trials in cancer
    • DOI 10.2307/2531628
    • O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics. 1990;46:33-48. (Pubitemid 20245604)
    • (1990) Biometrics , vol.46 , Issue.1 , pp. 33-48
    • O'Quigley, J.1    Pepe, M.2    Fisher, L.3
  • 26
    • 0041833622 scopus 로고    scopus 로고
    • Dose-finding with two agents in Phase I oncology trials
    • DOI 10.1111/1541-0420.00058
    • Thall PF, Millikan RE, Mueller P, Lee S. Dose-finding with two agents in phase I oncology trials. Biometrics. 2003;59:487-96. (Pubitemid 37093387)
    • (2003) Biometrics , vol.59 , Issue.3 , pp. 487-496
    • Thall, P.F.1    Millikan, R.E.2    Mueller, P.3    Lee, S.-J.4
  • 27
    • 33745956991 scopus 로고    scopus 로고
    • An adaptive dose-finding design incorporating both toxicity and efficacy
    • DOI 10.1002/sim.2325
    • Zhang W, Sargent DJ, Mandrekar S. An adaptive dosefinding design incorporating both toxicity and efficacy. Stat Med. 2006;25:2365-83. (Pubitemid 44057044)
    • (2006) Statistics in Medicine , vol.25 , Issue.14 , pp. 2365-2383
    • Zhang, W.1    Sargent, D.J.2    Mandrekar, S.3
  • 28
    • 77956823500 scopus 로고    scopus 로고
    • A hierarchical Bayesian design for phase I trials of novel combinations of cancer therapeutic agents
    • Braun TM, Wang SA. A hierarchical Bayesian design for phase I trials of novel combinations of cancer therapeutic agents. Biometrics. 2010;66:805-12.
    • (2010) Biometrics , vol.66 , pp. 805-812
    • Braun, T.M.1    Wang, S.A.2
  • 29
  • 30
  • 32
    • 0037186407 scopus 로고    scopus 로고
    • A flexible design for multiple armed screening trials
    • Sargent DJ, Goldberg RM. A flexible design for multiple armed screening trials. Stat Med. 2002;21:625-28.
    • (2002) Stat Med , vol.21 , pp. 625-628
    • Sargent, D.J.1    Goldberg, R.M.2
  • 34
    • 70449420123 scopus 로고    scopus 로고
    • Use of archived specimens in evaluation of prognostic and predictive biomarkers
    • Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009;101:1446-52.
    • (2009) J Natl Cancer Inst , vol.101 , pp. 1446-1452
    • Simon, R.M.1    Paik, S.2    Hayes, D.F.3
  • 35
    • 69849108427 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges
    • Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol. 2009;27:4027-34.
    • (2009) J Clin Oncol , vol.27 , pp. 4027-4034
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 36
    • 15744374441 scopus 로고    scopus 로고
    • Clinical trial designs for predictive marker validation in cancer treatment trials
    • DOI 10.1200/JCO.2005.01.112
    • Sargent DJ, Conley BA, Allegra C, Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol. 2005;23:2020-27. (Pubitemid 46211382)
    • (2005) Journal of Clinical Oncology , vol.23 , Issue.9 , pp. 2020-2027
    • Sargent, D.J.1    Conley, B.A.2    Allegra, C.3    Collette, L.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.