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Volumn 23, Issue 2, 2013, Pages 413-424

Evaluation of early efficacy endpoints for proof-of-concept trials

Author keywords

Benefit cost ratio; Decision analysis; Expected power; Oncology

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER;

EID: 84874491035     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2011.616969     Document Type: Article
Times cited : (26)

References (17)
  • 1
    • 0035100888 scopus 로고    scopus 로고
    • Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
    • Biomarker Definitions Working Group.
    • Biomarker Definitions Working Group. (2001). Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 69:89-95.
    • (2001) Clinical Pharmacology and Therapeutics , vol.69 , pp. 89-95
  • 3
    • 0031708453 scopus 로고    scopus 로고
    • The validation of surrogate endpoints in randomized experiments
    • Buyse, M., Molenberghs, G. (1998). The validation of surrogate endpoints in randomized experiments. Biometrics 54:1014-1029.
    • (1998) Biometrics , vol.54 , pp. 1014-1029
    • Buyse, M.1    Molenberghs, G.2
  • 4
    • 0030464206 scopus 로고    scopus 로고
    • On the relationship between response to treatment and survival time
    • Buyse, M., Piedbois, P. (1996). On the relationship between response to treatment and survival time. Statistics in Medicine 15:2797-2812.
    • (1996) Statistics in Medicine , vol.15 , pp. 2797-2812
    • Buyse, M.1    Piedbois, P.2
  • 5
    • 0001863948 scopus 로고    scopus 로고
    • The validation of surrogate endpoints in meta-analyses of randomized experiments
    • Buyse, M., et al. (2000). The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics 1:49-67.
    • (2000) Biostatistics , vol.1 , pp. 49-67
    • Buyse, M.1
  • 6
    • 67651027168 scopus 로고    scopus 로고
    • Optimal cost-effective designs of proof of concept trials and associated GoYNo Go decisions
    • Chen, C., Beckman, B. (2009a). Optimal cost-effective designs of proof of concept trials and associated GoYNo Go decisions. Journal of Biopharmaceutical Statistics 19(2):424-436.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , Issue.2 , pp. 424-436
    • Chen, C.1    Beckman, B.2
  • 7
    • 78650851915 scopus 로고    scopus 로고
    • Optimal cost-effective GoYNo Go decisions in late-stage oncology drug development
    • Chen, C., Beckman, R. A. (2009b). Optimal cost-effective GoYNo Go decisions in late-stage oncology drug development. Statistics in Biopharmaceutical Research 1:159-169.
    • (2009) Statistics in Biopharmaceutical Research , vol.1 , pp. 159-169
    • Chen, C.1    Beckman, R.A.2
  • 9
    • 24644506259 scopus 로고    scopus 로고
    • Objective response rate as a surrogate endpoint: A commentary
    • Fleming, T. R. (2005). Objective response rate as a surrogate endpoint: A commentary. Journal of Clinical Oncology 23:4845-4846.
    • (2005) Journal of Clinical Oncology , vol.23 , pp. 4845-4846
    • Fleming, T.R.1
  • 10
    • 23744479628 scopus 로고    scopus 로고
    • Using categorical markers as auxiliary variables in log-rank test and hazard ratio estimation
    • Mackenzie, T., Abrahamowicz, M. (2005). Using categorical markers as auxiliary variables in log-rank test and hazard ratio estimation. Canadian Journal of Statistics 33:201-219.
    • (2005) Canadian Journal of Statistics , vol.33 , pp. 201-219
    • Mackenzie, T.1    Abrahamowicz, M.2
  • 11
    • 0036916785 scopus 로고    scopus 로고
    • Statistical challenges in the evaluation of surrogate endpoints in randomized trials
    • Molenberghs, G., et al. (2002). Statistical challenges in the evaluation of surrogate endpoints in randomized trials. Controlled Clinical Trials 23:607-625.
    • (2002) Controlled Clinical Trials , vol.23 , pp. 607-625
    • Molenberghs, G.1
  • 12
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: Definitions and operational criteria
    • Prentice, R. L. (1989). Surrogate endpoints in clinical trials: Definitions and operational criteria. Statistics in Medicine 8:431-440.
    • (1989) Statistics in Medicine , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 13
    • 0002903432 scopus 로고
    • Information recovery and bias adjustment in proportional hazards regression analysis of randomized trials using surrogate markers
    • Robins, J. M. (1993). Information recovery and bias adjustment in proportional hazards regression analysis of randomized trials using surrogate markers. Proceedings of Biopharmaceutical Section, American Statistical Association. pp. 24-33.
    • (1993) Proceedings of Biopharmaceutical Section, American Statistical Association. , pp. 24-33
    • Robins, J.M.1
  • 14
    • 0033864536 scopus 로고    scopus 로고
    • Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests
    • Robins, J. M., Finkelstein, D. M. (2000). Correcting for noncompliance and dependent censoring in an AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics 56:779-788.
    • (2000) Biometrics , vol.56 , pp. 779-788
    • Robins, J.M.1    Finkelstein, D.M.2
  • 15
    • 33644834827 scopus 로고    scopus 로고
    • Disease-free survival (DFS) vs. overall survival (OS) as a primary endpoint for adjuvant colon cancer studies: Individual patient data from 20, 898 patents on 18 randomized trials
    • Sargent, D., Wieand, S., Haller, D. G., et al. (2005). Disease-free survival (DFS) vs. overall survival (OS) as a primary endpoint for adjuvant colon cancer studies: Individual patient data from 20, 898 patents on 18 randomized trials. Journal of Clinical Oncology 23:8664-8670.
    • (2005) Journal of Clinical Oncology , vol.23 , pp. 8664-8670
    • Sargent, D.1    Wieand, S.2    Haller, D.G.3
  • 16
    • 35649022759 scopus 로고    scopus 로고
    • Surrogate end points for median overall survival in metastatic colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy
    • Tang, P. A., Bentzen, S. M., Chen, E. X., Siu, L. L. (2007). Surrogate end points for median overall survival in metastatic colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. Journal of Clinical Oncology 25:4562-4568.
    • (2007) Journal of Clinical Oncology , vol.25 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3    Siu, L.L.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.