Modelling clustered survival data from multicentre clinical trials

Statistics in Medicine

Volumn 23, Issue 3, 2004, Pages 369-388

  Glidden, David V ^a   Vittinghoff, Eric ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Centre effects; Frailty models; Multicentre trials; Survival analysis; treatment by centre interaction

Indexed keywords

PLACEBO; RALOXIFENE;

AGED; ANKLE FRACTURE; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MONTE CARLO METHOD; MULTICENTER STUDY; NONBIOLOGICAL MODEL; OUTCOMES RESEARCH; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; REVIEW; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS; STATISTICAL MODEL; SURVIVAL;

HUMANS; MODELS, STATISTICAL; MULTICENTER STUDIES; RANDOMIZED CONTROLLED TRIALS; SURVIVAL ANALYSIS; UNITED STATES;

EID: 0842303548     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1599     Document Type: Review

References (54)

1. Agresti A, Hartzel J. Strategies for comparing treatment on a binary response with multicentre data. Statistics in Medicine 2000; 19(8):1115-1139.
2. Localio AR, Berlin JA, Ten Have TR, Kimmel SE. Adjustments for centre in multicentre studies: an overview. Annals of Internal Medicine 2001; 135(2):112-123.
3. Gould AL. Multi-centre trial analysis revisited. Statistics in Medicine 1998; 17(15, 16):1779-1797.
4. Jones B, Teather D, Wang J, Lewis JA. A comparison of various estimators of a treatment difference for a multi-centre clinical trial. Statistics in Medicine 1998; 17(15-16):1767-1777.
5. Senn S. Some controversies in planning and analysing multi-centre trials. Statistics In Medicine 1998; 17 (15-16):1753-1765.
6. Beitler PJ, Landis JR. A mixed-effects model for categorical data (correction 42: 1009). Biometrics 1985; 41(4):991-1000.
7. Fleiss JL. Analysis of data from multiclinic trials. Controlled Clinical Trials 1986; 7(4):267-275.
8. Grizzle JE. Letter to the editor. Controlled Clinical Trials 1987; 8(4):392-393.
9. Neuhaus JM, Kalbfleisch JD, Hauck WW. A comparison of cluster-specific and population-averaged approaches for analyzing correlated binary data. International Statistical Review 1991; 59(1):25-35.
10. Lindsey JK, Lambert P. On the appropriateness of marginal models for repeated measurements in clinical trials. Statistics in Medicine 1998; 17(4):447-469.
11. Wei LJ, Glidden DV. An overview of statistical methods for multiple failure time data in clinical trials. Statistics in Medicine 1997; 16(8):833-839.
12. Lin DY. Cox regression analysis of multivariate failure time data - the marginal approach. Statistics in Medicine 1994; 13(21):2233-2247.
13. Wei LJ, Lin DY, Weissfeld L. Regression analysis of multivariate incomplete failure time data by modelling marginal distributions. Journal of the American Statistical Association 1989; 84(408):1065-1079.
14. Lee EW, Wei LJ, Amato DA. Cox-type regression analysis for large number of small groups of correlated failure time observations. In Survival Analysis: State of the Art, Klein JP, Goel PK (eds). Kluwer: Dordrecht, 1992.
15. Nielsen GG, Gill RD, Andersen PK, Sørensen TIA. A counting process approach to maximum likelihood estimation in frailty models. Scandinavian Journal of Statistics 1992; 19(1):25-43.
16. Aalen OO. Heterogeneity in survival analysis. Statistics in Medicine 1988; 7(1):1109-1120.
17. Henderson R, Oman P. Effect of frailty on marginal regression estimates in survival analysis. Journal of the Royal Statistical Society, Series B 1999; 61(2):367-379.
18. Holt JD, Prentice RL. Survival analyses in twin studies and matched pair experiments. Biometrika 1974; 61(1):17-30.
19. Clayton DG. Model for association in bivariate life tables and its application in epidemiological studies of familial tendency in chronic disease incidence. Biometrika 1978; 65(1):141-151.
20. Hougaard P. Survival models for heterogeneous populations derived from stable distributions. Biometrika 1986; 73(3):387-396.
21. McGilchrist CA. REML estimation for survival models with frailty. Biometrics 1993; 49(1):221-225.
22. Ripatti S, Palmgren J. Estimation of multivariate frailty models using penalized partial likelihood. Biometrics 2000; 56(4):1016-1022.
23. Vaida F, Xu RH. Proportional hazards model with random effects. Statistics in Medicine 2000; 19(24): 3309-3324.
24. Heinze G, Schemper L. A solution to the problem of monotone likelihood in Cox regression. Biometrics 2001; 57(1):114-119.
25. Murphy SA. Consistency in a proportional hazards model incorporating a random effect. Annals of Statistics 1994; 22(2):712-731.
26. Murphy SA. Asymptotic theory for the frailty model. Annals of Statistics 1995; 23(1):182-198.
27. Parner E. Asymptotic theory for the correlated gamma-frailty model. Annals of Statistics 1998; 26(1):183-214.
28. Klein JP. Semiparametric estimation of random effects using the Cox model based on the EM algorithm. Biometrics 1992; 48(3):795-806.
29. Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. Springer: New York, 2000.
30. Gray RJ. Tests for variation over groups in survival data. Journal of the American Statistical Association 1995; 90(429):198-203.
31. Gray RJ. On tests for group variation with a small to moderate number of groups. Lifetime Data Analysis 1998; 4(2):139-148.
32. Commenges D, Andersen PK. Score test of homogeneity for survival data. Lifetime Data Analysis 1995; 1(2):145-160.
33. Andersen PK, Klein JP, Zhang MJ. Testing for centre effects in multi-centre survival studies: a Monte Carlo comparison of fixed and random effects tests. Statistics in Medicine 1999; 18(12):1489-1500.
34. Louis TA. Using empirical Bayes methods in biopharmaceutical research. Statistics in Medicine 1991; 10(6):811-829.
35. Gail M, Simon R. Testing for qualitative interaction between treatment effects and patient subsets. Biometrics 1985; 41(2):361-372.
36. Raghunathan TE, Ii Y. Analysis of binary data from a multicentre clinical-trial. Biometrika 1993; 80(1):127-139.
37. Petersen JH. An additive frailty model for correlated life times. Biometrics 1998; 54(2):646-661.
38. Gray RJ. A Bayesian analysis of institutional effects in a multicentre cancer clinical-trial. Biometrics 1994; 50(1):244-253.
39. Yamaguchi T, Ohashi Y. Investigating centre effects in a multicentre clinical trial of superficial bladder cancer. Statistics in Medicine 1999; 18(3):1961-1971.
40. Potthoff RF, Peterson BL, George SL. Detecting treatment-by-centre interaction in multicentre clinical trials. Statistics in Medicine 2001; 20(2):193-213.
41. Liang K-Y, Self SG. Testing for homogeneity of odds ratio when the data are sparse. Biometrika 1985; 72(2):353-358.
42. Zelen M. The analysis of several 2 × 2 contingency tables. Biometrika 1971; 58(1):129-137.
43. Lipsitz SR, Dear KBG, Laird NM, Molenberghs G. Tests for homogeneity of the risk difference when data are sparse. Biometrics 1998; 54(1):148-160.
44. Cai JW, Sen PK, Zhou HB. A random effects model for multivariate failure time data from multicentre clinical trials. Biometrics 1999; 55(1):182-189.
45. Cai JW, Zhou HB, Davis CE. Estimating the mean hazard ratio parameters for clustered survival data with random clusters. Statistics in Medicine 1997; 16(17):2009-2020.
46. DerSimonian R, Laird N. Metaanalysis in clinical trials. Controlled Clinical Trials 1986; 7(3):177-188.
47. Norman SLT. Meta analysis: formulating, evaluating, combining and reporting. Statistics in Medicine 1999; 18(3):321-359.
48. James W, Stein C. Estimation with quadratic loss. Proceeding of the 4th Berkeley Symposium on Mathematical Statistics and Probabilities, vol. 1. University of California Press: California, 1961; 361-379.
49. Morris C. Parametric empirical Bayes inference: theory and applications. Journal of the American Statistical Association 1983; 78(381):47-59.
50. Cummings SR, Eckert S, Krueger KA, Grady D, Powles TJ, Cauley JA, Norton L, Nickelsen T, Bjarnason NH, Morrow M, Lippman ME, Black D. Glusman JE, Costa A, Jordan VC. The effect of raloxifene on risk of breast cancer in postmenopausal women - results from the MORE randomized trial. Journal of the American Medical Association 1999; 281(23):2189-2197.
51. Hougaard P. Analysis of Multivariate Survival Data. Springer: New York, 2000.
52. Shih JH, Louis TA. Inferences on the association parameter in copula models for bivariate survival data. Biometrics 1995; 51(4):1384-1399.
53. Glidden DV. Checking the adequacy of the gamma frailty model for multivariate failure times. Biometrika 1999; 86(2):381-393.
54. Neuhaus JM, Hauck WW, Kalbfleisch JD. The effects of mixture distribution misspecification when fitting mixed-effects logistic-models. Biometrika 1992; 79(4):755-762.