Individual- and trial-level surrogacy in colorectal cancer:

作者: Marc Buyse , Tomasz Burzykowski , Stefan Michiels , Kevin Carroll

DOI: 10.1177/0962280207081864

关键词:

摘要: Two conditions must be fulfilled for an intermediate endpoint to acceptable surrogate a true clinical endpoint: (1) there strong association between the and endpoint, (2) effects of treatment on endpoint. We test whether these are disease-free survival (DFS) progression-free (PFS) data from 20 trials comparing experimental treatments with standard early advanced colorectal cancer. The DFS (or PFS in disease) OS were quantified through log hazard ratios (log HR), estimated Weibull model stratified trial. rank correlation coefficients OS, trial-specific effects, using bivariate copula distribution endpoints. A linear regression was used compute “surrogate thresho...

参考文章(15)
David R. Cox, Regression Models and Life-Tables Springer Series in Statistics. ,vol. 34, pp. 527- 541 ,(1992) , 10.1007/978-1-4612-4380-9_37
Marc Buyse, Geert Molenberghs, Criteria for the validation of surrogate endpoints in randomized experiments Biometrics. ,vol. 54, pp. 1014- 1029 ,(1998) , 10.2307/2533853
Tomasz Burzykowski, Surrogate endpoints: wishful thinking or reality? Statistical Methods in Medical Research. ,vol. 17, pp. 463- 466 ,(2008) , 10.1177/0962280207081866
Tomasz Burzykowski, Marc Buyse, Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation. Pharmaceutical Statistics. ,vol. 5, pp. 173- 186 ,(2006) , 10.1002/PST.207
Thomas R. Fleming, Surrogate End Points in Clinical Trials: Are We Being Misled? Annals of Internal Medicine. ,vol. 125, pp. 605- 613 ,(1996) , 10.7326/0003-4819-125-7-199610010-00011
Tomasz Burzykowski, Geert Molenberghs, Marc Buyse, Helena Geys, Didier Renard, Validation of surrogate end points in multiple randomized clinical trials with failure time end points Journal of The Royal Statistical Society Series C-applied Statistics. ,vol. 50, pp. 405- 422 ,(2001) , 10.1111/1467-9876.00244
Marc Buyse, Pierre Thirion, Robert W Carlson, Tomasz Burzykowski, Geert Molenberghs, Pascal Piedbois, Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis The Lancet. ,vol. 356, pp. 373- 378 ,(2000) , 10.1016/S0140-6736(00)02528-9
M. Buyse, G. Molenberghs, T. Burzykowski, D. Renard, H. Geys, The validation of surrogate endpoints in meta-analyses of randomized experiments Biostatistics. ,vol. 1, pp. 49- 67 ,(2000) , 10.1093/BIOSTATISTICS/1.1.49
P. J. Rousseeuw, A. M. Leroy, Robust Regression and Outlier Detection ,(1987)