메뉴 건너뛰기




Volumn 138, Issue 2, 2008, Pages 432-449

The meta-analytic framework for the evaluation of surrogate endpoints in clinical trials

Author keywords

Hierarchical model; Likelihood reduction factor; Meta analysis; Random effects model; Surrogate endpoint; Surrogate threshold effect

Indexed keywords


EID: 35348845780     PISSN: 03783758     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jspi.2007.06.005     Document Type: Article
Times cited : (16)

References (40)
  • 1
    • 34247258392 scopus 로고    scopus 로고
    • Surrogate marker evaluation from an information theoretic perspective
    • Alonso A., and Molenberghs G. Surrogate marker evaluation from an information theoretic perspective. Biometrics 63 (2006) 180-186
    • (2006) Biometrics , vol.63 , pp. 180-186
    • Alonso, A.1    Molenberghs, G.2
  • 2
    • 0347022252 scopus 로고    scopus 로고
    • Validation of surrogate markers in multiple randomized clinical trials with repeated measurements
    • Alonso A., Geys H., Molenberghs G., and Vangeneugden T. Validation of surrogate markers in multiple randomized clinical trials with repeated measurements. Biometrical J. 45 (2003) 931-945
    • (2003) Biometrical J. , vol.45 , pp. 931-945
    • Alonso, A.1    Geys, H.2    Molenberghs, G.3    Vangeneugden, T.4
  • 3
    • 4444354104 scopus 로고    scopus 로고
    • Prentice's approach and the meta analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints
    • Alonso A., Molenberghs G., Burzykowski T., Renard D., Geys H., Shkedy Z., Tibaldi F., Abrahantes J., and Buyse M. Prentice's approach and the meta analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints. Biometrics 60 (2004) 724-728
    • (2004) Biometrics , vol.60 , pp. 724-728
    • Alonso, A.1    Molenberghs, G.2    Burzykowski, T.3    Renard, D.4    Geys, H.5    Shkedy, Z.6    Tibaldi, F.7    Abrahantes, J.8    Buyse, M.9
  • 4
    • 31344445418 scopus 로고    scopus 로고
    • A unifying approach for surrogate marker validation based on Prentice's criteria
    • Alonso A., Molenberghs G., Geys H., and Buyse M. A unifying approach for surrogate marker validation based on Prentice's criteria. Statist. Med. 25 (2005) 205-211
    • (2005) Statist. Med. , vol.25 , pp. 205-211
    • Alonso, A.1    Molenberghs, G.2    Geys, H.3    Buyse, M.4
  • 5
    • 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. 69 (2001) 89-95
    • (2001) Clin. Pharmacol. Ther. , vol.69 , pp. 89-95
  • 6
    • 33748751897 scopus 로고    scopus 로고
    • Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation
    • Burzykowski T., and Buyse M. Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation. Pharm. Statist. 5 (2006) 173-186
    • (2006) Pharm. Statist. , vol.5 , pp. 173-186
    • Burzykowski, T.1    Buyse, M.2
  • 7
    • 0035648331 scopus 로고    scopus 로고
    • Validation of surrogate endpoints in multiple randomized clinical trials with failure-time endpoints
    • Burzykowski T., Molenberghs G., Buyse M., Renard D., and Geys H. Validation of surrogate endpoints in multiple randomized clinical trials with failure-time endpoints. Appl. Statist. 50 (2001) 405-422
    • (2001) Appl. Statist. , vol.50 , pp. 405-422
    • Burzykowski, T.1    Molenberghs, G.2    Buyse, M.3    Renard, D.4    Geys, H.5
  • 8
    • 1542403912 scopus 로고    scopus 로고
    • The validation of surrogate endpoints using data from randomized clinical trials: a case-study in advanced colorectal cancer
    • Burzykowski T., Molenberghs G., and Buyse M. The validation of surrogate endpoints using data from randomized clinical trials: a case-study in advanced colorectal cancer. J. Roy. Statist. Soc. Ser. A 167 (2004) 103-124
    • (2004) J. Roy. Statist. Soc. Ser. A , vol.167 , pp. 103-124
    • Burzykowski, T.1    Molenberghs, G.2    Buyse, M.3
  • 10
    • 0031708453 scopus 로고    scopus 로고
    • The validation of surrogate endpoints in randomized experiments
    • Buyse M., and Molenberghs G. The validation of surrogate endpoints in randomized experiments. Biometrics 54 (1998) 1014-1029
    • (1998) Biometrics , vol.54 , pp. 1014-1029
    • Buyse, M.1    Molenberghs, G.2
  • 11
    • 0001863948 scopus 로고    scopus 로고
    • The validation of surrogate endpoints in meta-analyses of randomized experiments
    • Buyse M., Molenberghs G., Burzykowski T., Renard D., and Geys H. The validation of surrogate endpoints in meta-analyses of randomized experiments. Biostatistics 1 (2000) 49-67
    • (2000) Biostatistics , vol.1 , pp. 49-67
    • Buyse, M.1    Molenberghs, G.2    Burzykowski, T.3    Renard, D.4    Geys, H.5
  • 12
    • 0024321898 scopus 로고
    • Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infraction
    • Cardiac Arrhythmia Suppression Trial (CAST) Investigators
    • Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infraction. N. Engl. J. Med. 321 (1989) 406-412
    • (1989) N. Engl. J. Med. , vol.321 , pp. 406-412
  • 13
    • 0017883262 scopus 로고
    • A model for association in bivariate life tables and its application in epidemiological studies of familial tendency in chronic disease incidence
    • Clayton D.G. A model for association in bivariate life tables and its application in epidemiological studies of familial tendency in chronic disease incidence. Biometrika 65 (1978) 141-151
    • (1978) Biometrika , vol.65 , pp. 141-151
    • Clayton, D.G.1
  • 16
    • 0023021371 scopus 로고
    • Global cross ratio models for bivariate, discrete, ordered responses
    • Dale J.R. Global cross ratio models for bivariate, discrete, ordered responses. Biometrics 42 (1986) 909-917
    • (1986) Biometrics , vol.42 , pp. 909-917
    • Dale, J.R.1
  • 17
    • 0030777744 scopus 로고    scopus 로고
    • Meta-analysis for the evaluation of potential surrogate markers
    • Daniels M.J., and Hughes M.D. Meta-analysis for the evaluation of potential surrogate markers. Statist. Med. 16 (1997) 1515-1527
    • (1997) Statist. Med. , vol.16 , pp. 1515-1527
    • Daniels, M.J.1    Hughes, M.D.2
  • 18
    • 0028627762 scopus 로고
    • Modelling progression of CD-4 lymphocyte count and its relationship to survival time
    • DeGruttola V., and Tu X.M. Modelling progression of CD-4 lymphocyte count and its relationship to survival time. Biometrics 50 (1994) 1003-1014
    • (1994) Biometrics , vol.50 , pp. 1003-1014
    • DeGruttola, V.1    Tu, X.M.2
  • 19
    • 0036020644 scopus 로고    scopus 로고
    • Integrating pharmacogenomics into drug development
    • Ferentz A.E. Integrating pharmacogenomics into drug development. Pharmacogenomics 3 (2002) 453-467
    • (2002) Pharmacogenomics , vol.3 , pp. 453-467
    • Ferentz, A.E.1
  • 20
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate endpoints in clinical trials: are we being misled?
    • Fleming T.R., and DeMets D.L. Surrogate endpoints in clinical trials: are we being misled?. Ann. Intern. Med. 125 (1996) 605-613
    • (1996) Ann. Intern. Med. , vol.125 , pp. 605-613
    • Fleming, T.R.1    DeMets, D.L.2
  • 21
    • 0026573094 scopus 로고
    • Statistical validation of intermediate endpoints for chronic diseases
    • Freedman L.S., Graubard B.I., and Schatzkin A. Statistical validation of intermediate endpoints for chronic diseases. Statist. Med. 11 (1992) 167-178
    • (1992) Statist. Med. , vol.11 , pp. 167-178
    • Freedman, L.S.1    Graubard, B.I.2    Schatzkin, A.3
  • 23
    • 0001067751 scopus 로고
    • General class of covariance structures for two or more repeated factors in longitudinal data analysis
    • Galecki A. General class of covariance structures for two or more repeated factors in longitudinal data analysis. Comm. Statist. Theory Methods 23 (1994) 3105-3119
    • (1994) Comm. Statist. Theory Methods , vol.23 , pp. 3105-3119
    • Galecki, A.1
  • 24
    • 84953078660 scopus 로고
    • The joy of copulas: bivariate distributions with uniform marginals
    • Genest C., and McKay J. The joy of copulas: bivariate distributions with uniform marginals. Amer. Statist. 40 (1986) 280-283
    • (1986) Amer. Statist. , vol.40 , pp. 280-283
    • Genest, C.1    McKay, J.2
  • 25
    • 0001586998 scopus 로고
    • Survival models for heterogeneous populations derived from stable distributions
    • Hougaard P. Survival models for heterogeneous populations derived from stable distributions. Biometrika 73 (1986) 387-396
    • (1986) Biometrika , vol.73 , pp. 387-396
    • Hougaard, P.1
  • 26
    • 0000936017 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. Fed. Regist. 63 179 (1998) 49583
    • (1998) Fed. Regist. , vol.63 , Issue.179 , pp. 49583
  • 27
    • 0023606101 scopus 로고
    • The positive and negative syndrome scale (PANSS) for schizophrenia
    • Kay S.R., Fiszbein A., and Opler L.A. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bull. 13 (1987) 261-276
    • (1987) Schizophrenia Bull. , vol.13 , pp. 261-276
    • Kay, S.R.1    Fiszbein, A.2    Opler, L.A.3
  • 28
    • 0023858453 scopus 로고
    • Reliability and validity of the positive and negative syndrome scale for schizophrenics
    • Kay S.R., Opler L.A., and Lindenmayer J.P. Reliability and validity of the positive and negative syndrome scale for schizophrenics. Psychiatr. Res. 23 (1988) 99-110
    • (1988) Psychiatr. Res. , vol.23 , pp. 99-110
    • Kay, S.R.1    Opler, L.A.2    Lindenmayer, J.P.3
  • 29
    • 0026591512 scopus 로고
    • Surrogate markers in AIDS: where are we? Where are we going?
    • Lagakos S.W., and Hoth D.F. Surrogate markers in AIDS: where are we? Where are we going?. Ann. Intern. Med. 116 (1992) 599-601
    • (1992) Ann. Intern. Med. , vol.116 , pp. 599-601
    • Lagakos, S.W.1    Hoth, D.F.2
  • 30
    • 0035037328 scopus 로고    scopus 로고
    • Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria validation strategies
    • Lesko L.J., and Atkinson A.J. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria validation strategies. Annu. Rev. Pharmacol. Toxicol. 41 (2001) 347-366
    • (2001) Annu. Rev. Pharmacol. Toxicol. , vol.41 , pp. 347-366
    • Lesko, L.J.1    Atkinson, A.J.2
  • 31
    • 0035975996 scopus 로고    scopus 로고
    • Evaluation of surrogate end-points in randomized experiments with mixed discrete and continuous outcomes
    • Molenberghs G., Geys H., and Buyse M. Evaluation of surrogate end-points in randomized experiments with mixed discrete and continuous outcomes. Statist. Med. 20 (2001) 3023-3038
    • (2001) Statist. Med. , vol.20 , pp. 3023-3038
    • Molenberghs, G.1    Geys, H.2    Buyse, M.3
  • 32
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: definitions and operational criteria
    • Prentice R.L. Surrogate endpoints in clinical trials: definitions and operational criteria. Statist. Med. 8 (1989) 431-440
    • (1989) Statist. Med. , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 33
    • 0036921290 scopus 로고    scopus 로고
    • Validation of surrogate endpoints in multiple randomized clinical trials with discrete outcomes
    • Renard D., Geys H., Molenberghs G., Burzykowski T., and Buyse M. Validation of surrogate endpoints in multiple randomized clinical trials with discrete outcomes. Biometrical J. 44 (2002) 1-15
    • (2002) Biometrical J. , vol.44 , pp. 1-15
    • Renard, D.1    Geys, H.2    Molenberghs, G.3    Burzykowski, T.4    Buyse, M.5
  • 34
    • 0043172579 scopus 로고    scopus 로고
    • Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer
    • Royston P., Parmar M.K.B., and Qian W. Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer. Statist. Med. 22 (2003) 2239-2256
    • (2003) Statist. Med. , vol.22 , pp. 2239-2256
    • Royston, P.1    Parmar, M.K.B.2    Qian, W.3
  • 35
    • 0036372284 scopus 로고    scopus 로고
    • The promise and peril of surrogate end points in cancer research
    • Schatzkin A., and Gail M. The promise and peril of surrogate end points in cancer research. Natur. Rev. Cancer 2 (2002) 19-27
    • (2002) Natur. Rev. Cancer , vol.2 , pp. 19-27
    • Schatzkin, A.1    Gail, M.2
  • 36
    • 0029785607 scopus 로고    scopus 로고
    • Explained variation in survival analysis
    • Schemper M., and Stare J. Explained variation in survival analysis. Statist. Med. 15 (1996) 1999-2012
    • (1996) Statist. Med. , vol.15 , pp. 1999-2012
    • Schemper, M.1    Stare, J.2
  • 37
    • 84856043672 scopus 로고
    • A mathematical theory of communication
    • 623-656
    • Shannon C. A mathematical theory of communication. Bell Syst. Tech. J. 27 (1948) 379-423 623-656
    • (1948) Bell Syst. Tech. J. , vol.27 , pp. 379-423
    • Shannon, C.1
  • 38
    • 0029597951 scopus 로고
    • Inferences on association parameter in copula models for bivariate survival data
    • Shih J.H., and Louis T.A. Inferences on association parameter in copula models for bivariate survival data. Biometrics 51 (1995) 1384-1399
    • (1995) Biometrics , vol.51 , pp. 1384-1399
    • Shih, J.H.1    Louis, T.A.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.