Baseline and treatment effect heterogeneity for survival times between centers using a random effects accelerated failure time model with flexible error distribution

Statistics in Medicine

Volumn 26, Issue 30, 2007, Pages 5457-5472

  Komárek, Arnošt ^a,c   Lesaffre, Emmanual ^a   Legrand, Catherine ^b,d  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b European Organisation of Research and Treatment of Cancer   (Belgium)

^c CHARLES UNIVERSITY   (Czech Republic)

^d UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

Author keywords

Multi center study; Penalized Gaussian mixture; Regression; Survival analysis

Indexed keywords

ANTINEOPLASTIC AGENT;

ADULT; BAYES THEOREM; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL STUDY; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; HEALTH CENTER; HUMAN; MAJOR CLINICAL STUDY; MASTECTOMY; MATHEMATICAL COMPUTING; MONTE CARLO METHOD; MULTICENTER STUDY; NORMAL DISTRIBUTION; OUTCOME ASSESSMENT; PROBABILITY; RANDOM ERROR; REFERENCE VALUE; STATISTICAL ANALYSIS; STATISTICAL MODEL; SURVIVAL TIME; TREATMENT RESPONSE;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BAYES THEOREM; BIAS (EPIDEMIOLOGY); BIOMETRY; BREAST NEOPLASMS; EUROPE; HUMANS; LONGITUDINAL STUDIES; MARKOV CHAINS; MONTE CARLO METHOD; MULTICENTER STUDIES AS TOPIC; MULTIVARIATE ANALYSIS; PERIOPERATIVE CARE; REFERENCE VALUES; RESEARCH DESIGN; SOUTH AFRICA; SPACE-TIME CLUSTERING; STATISTICAL DISTRIBUTIONS; SURVIVAL ANALYSIS; TIME; TREATMENT OUTCOME;

EID: 38849203072     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3083     Document Type: Conference Paper

References (29)

1. Clahsen PC, van de Velde CJ, Julien JP, Floiras JL, Delozier T, Mignolet FY, Sahmoud TM. Improved local control and disease-free survival after perioperative chemotherapy for early-stage breast cancer. A European Organization for Research and Treatment of Cancer Breast Cancer Cooperative Group Study. Journal of Clinical Oncology 1996; 14:745-753.
2. van der Hage JA, van de Velde CJH, Julien J-P, Floiras J-L, Delozier T, Vandervelden C, Duchateau L. Improved survival after one course of perioperative chemotherapy in early breast cancer patients: long-term results from the European Organization for Research and Treatment of Cancer (EORTC) Trial 10854. European Journal of Cancer 2001; 37:2184-2193.
3. Anello C, O'Neill RT, Dubey S. Multicenter trials: a US regulatory perspective. Statistical Methods in Medical Research 2005; 14:303-318.
4. Cox DR. Regression models and life-tables (with Discussion). Journal of the Royal Statistical Society, Series B 1972; 34:187-220.
5. Cox DR. Partial likelihood. Biometrika 1975; 62:269-276.
6. Kalbfleisch JD, Prentice RL.The Statistical Analysis of Failure Time Data (2nd edn). Wiley: Chichester, 2002.
7. Reid N. A conversation with Sir David Cox. Statistical Science 1994; 9:439-455.
8. Komárek A, Lesaffre E, Hilton JF. Accelerated failure time model for arbitrarily censored data with smoothed error distribution. Journal of Computational and Graphical Statistics 2005; 14:726-745.
9. Komárek A, Lesaffre E. Bayesian accelerated failure time model with multivariate doubly-interval-censored data and flexible distributional assumptions. Journal of the American Statistical Association 2007, in press.
10. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982; 38:963-974.
11. Pan W, Louis TA. A linear mixed-effects model for multivariate censored data. Biometrics 2000; 56:160-166.
12. Pan W, Connett JE. A multiple imputation approach to linear regression with clustered censored data. Lifetime Data Analysis 2001; 7:111-123.
13. Komárek A, Lesaffre E. Bayesian accelerated failure time model for correlated censored data with a normal mixture as an error distribution. Statistica Sinica 2007; 17:549-569.
14. Làmbert P, Eilers PHC. Bayesian proportional hazards model with time-varying regression coefficients: a penalized Poisson regression approach. Statistics in Medicine 2005; 24:3977-3989.
15. Kneib T. Mixed model based inference in geoadditive hazard regression for interval censored survival times. Computational Statistics and Data Analysis 2006; 51:777-792.
16. Kneib T, Fahrmeir L. A mixed model approach for geoadditive hazard regression. Scandinavian Journal of Statistics 2007; 34:207-228.
17. Keiding N, Andersen PK, Klein JP. The role of frailty models and accelerated failure time models in describing heterogeneity due to omitted covariates. Statistics in Medicine 1997; 16:215-225.
18. Lambert P, Collett D, Kimber A, Johnson R. Parametric accelerated failure time models with random effects and an application to kidney transplant survival. Statistics in Medicine 2004; 23:3177-3192.
19. Eilers PHC, Marx BD. Flexible smoothing with B-splines and penalties (with Discussion). Statistical Science 1996; 11:89-121.
20. Wahba G. Bayesian 'confidence intervals' for the cross-validated smoothing spline. Journal of the Royal Statistical Society, Series B 1983; 45:133-150.
21. Robert CP, Casella G. Monte Carlo Statistical Methods (2nd edn). Springer: New York, 2004.
22. Rue H, Held L. Gaussian Markov Random Fields: Theory and Applications. Chapman & Hall/CRC: Boca Raton, FL, 2005.
23. Tanner MA, Wong WH. The calculation of posterior distributions by data augmentation. Journal of the American Statistical Association 1987; 82:528-550.
24. Geman S, Geman D. Stochastic relaxation, Gibbs distributions and the Bayes restoration of image. IEEE Transactions on Pattern Analysis and Machine Intelligence 1984; 6:721-741.
25. R Development Core Team. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing: Vienna, Austria, 2007. ISBN: 3-900051-07-0.
26. Hougaard P. Fundamentals of survival data. Biometrics 1999; 55:13-22.
27. Legrand C, Duchateau L, Sylvester R, Janssen P, van der Hage JA, van de Velde CJH, Therasse P. Heterogeneity in disease free survival between centers: lessons learned from an EORTC breast cancer trial. Clinical Trials 2006; 3:10-18.
28. Glidden DV, Vittinghoff E. Modelling clustered survival data from multicentre clinical trials. Statistics in Medicine 2004; 23:369-388.
29. Committee for Proprietary Medicinal Products. Points to Consider on Adjustment for Baseline Covariates. The European Agency for the Evaluation of Medical Products, Evaluation of Medicines for Human Use, London, May 2003. CPMP/EWP/2863/99.