A Study on the Group Sequential Methods for Comparing Survival Distributions in Clinical Trials

  • Jae Won Lee (Department of Statistics, Korea University)
  • Published : 1998.08.01


In many clinical trials, we are interested in comparing the failure time distribution of different treatment groups. Because of ethical and economic reasons, clinical trials need to be monitored for early dramatic benefits or potential harmful effects. Prior knowledge, evolving knowledge, statistical considerations, medical judgment and ethical principles are all involved in the decision to terminate a trial early, and thus the monitoring is usually carried out by an independent scientific committee. This paper reviews the recently proposed group sequential testing procedures for clinical trials with survival data. Design considerations of such clinical trials are also discussed. This paper compares the characteristics of each of these methods and provides the biostatisticians with the guidelines for choosing the appropriate group sequential methods in a given situation.



  1. Biometrika v.66 Linear regression with censored data Buckley, J.;James, I.
  2. Biometrika v.62 Partial likelihood Cox, D. R.
  3. Survival Analysis, IMS Lecture Notes Monograph Series 2 Simulation studies on increments of the two-sample logrank score test for survival data, with application to group sequential boundaries Gail, M. H.;DeMets, D. L.;Slud, E. V.;Johnson(ed.);Crowley(ed.)
  4. Biometrics v.51 Sequential methods for comparison of cure rates in clinical trials Lee, J. W.;Sather, H. N.
  5. Journal of the Royal Statistical Society, Ser.A v.134 Repeated significance tests on accumulating data when the null hypothesis is not true McPherson, C. K.;Armitage, P.
  6. Biometrika v.81 A resampling method based on pivotal estimating functions Parze, M. I.;Wei, L. J.;Ying, Z.
  7. Biometrika v.64 Group sequential methods in the design and analysis of clinical trials Pocock, S. J.
  8. Biometrika v.65 Linear rank tests with right censored data Prentice, R. L.
  9. Biometrika v.70 Sequential analysis of the proportional hazard model Sellke, T.;Siegmund, D.
  10. Annals of Statistics v.21 A sequential clinical trial for comparing three treatments Siegmund, D.
  11. Journal of the American Statistical Association v.79 Two-sample asymptotically distribution-free tests for incomplete multivariate observations Wei, L. J.;Lachin, J. M.
  12. Biometrika v.72 Combining dependent tests with incomplete repeated measurements Wei, L. J.;Johnson, W. E.
  13. Sample size determination for stratified survival studies Kim, S. W.;Park, M.;Lee, J. W.
  14. Biometrics v.38 The use of mixture models for the analysis of survival data with long-term survivors Farewell, V. T.
  15. Biometrics v.42 Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification Lachin, J. M.;Foulkes, M. A.
  16. Statistics in Medicine v.11 Study duration for group sequential clinical trials with censored survival data adjusting for stratification Kim, K.
  17. Biometrika v.72 Group sequential tests with censored survival data adjusting for covariates Tsiatis, A. A.;Rosner, G. L.;Tritchler, D. L.
  18. Sequential Medical Trials(2nd edition) Armitage, P.
  19. Journal of the American Statistical Association v.77 Repeated significance testing for a general class of statistics used in censored survival analysis Tsiatis,m A. A.
  20. Biometrics v.39 Sample-size formula for the proportional-hazards regression model Schoenfeld, D. A.
  21. Biometrics v.41 Use of logrank tests and group sequential methods at fixed calendar times DeMets, D. L.;Gail, M. H.
  22. The Statistical Analysis of Failure Time Data Kalbfleisch, J. D.;Prentice, R. L.
  23. Biometrics v.35 A multiple testing procedure for clinical trials O'Brien, P. C.;Fleming, T. R.
  24. Biometrika v.79 Sequential logrank tests adjusting for covariates with covariates with the accelerated life nodel Lin, D. Y.
  25. Biometrics v.48 Effects of assumption violations on type I error rate in group sequential monitoring Proschan, M. A.;Follmann, D. A.;Waclawiw, M. A.
  26. Biometrics v.51 Design and analysis of group sequential logrank tests in maximum duration versus information trials Kim, K.;Boucher, H.;Tsiatis, A. A.
  27. Biometrics v.45 A linear rank test for use when the main interest is in differences in cure rates Gray, R. J.;Tsiatis, A. A.
  28. Annals of Statistics v.12 Sequential linear rank tests for two-sample censored survival data Slud, E. V.
  29. Journal of Applied Statistics Sample size determination for comparative Park, M.;Kim, S. W.;Lee, J. W.
  30. The Korean Journal of Applied Statistics v.7 no.2 An overview of group sequential procedures Lee, J. W.
  31. Biometrics v.52 Group sequential designs for monitoring survival probabilities Lin, D. Y.;Shen, L.;Ying, Z.;Breslow, N. E.
  32. Applied Statistics v.33 Multivariate normal probabilities with error bound (with corrections in 1985) Schervish, M. J.
  33. Controlled Clinical Trials v.2 Introduction to sample size determination and power analysis for clinical trials Lachin, J. M.
  34. Journal of Applied Probability v.6 On large sample sequential analysis with applications to survivalship data Breslow, N.
  35. Journal of Chronic Diseases v.38 Consideration of covariates and stratification in sample size determination for survival time studies Palta, M.;Amini, S.
  36. Biometrika v.82 Sequential methods for parametric survival models Tsiatis, A. A.;Boucher, H.;Kim, K.
  37. Biometrika v.81 Interim analyses based on median survival times Keaney, K. M.;Wei, L. J.
  38. Journal of Statistical Computing and Simulation v.8 Sample size and power determination for stratified clinical trials Bernstein, D.;Lagakos, S. W.
  39. Biometrika v.70 Discrete sequential boundaries for clinical trials Lan, K. K. G.;DeMets, D. L.
  40. Biometrics v.53 Sequential analysis of censored survival data from three treatment groups Betensky, R. A.
  41. Biometrics v.43 Approximately optimal one-parameter boundaries for group sequential approach Wang, S. K.;Tsiatis, A. A.
  42. Journal of Chronic Disease Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation Rubinstein, L. V.;Gail, M. H.;Santner, T. J.
  43. Biometrika v.78 Nonparametric sequential testing in clinical trials with incomplete multivariate observations Lin, D. Y.
  44. Biometrics v.51 Sequential monitoring of survival data with the Wilcoxon statistic Lan, K. K. G.;Rosenberger, W. F.;Lachin, J. M.
  45. Journal of the Royal Statistical Society, Ser. B v.51 Interim analysis: The repeated confidence interval approach Jennison, C.;Turnbull, B. W.
  46. Journal of the Royal Statistical Society, Ser. A v.135 Asymptotically efficient rank invariant procedures (with discussion) Peto, R.;Peto, J.
  47. Technical Report 60, University of Wisconsin-Madison, Biostatistics Center Programs for computing Lan-DeMets bounds Reboussin, D. M.;DeMets, D. L.;Kim, K.;Lan, K. K. L.
  48. Biometrika v.69 A class of rank test procedures for censored survival data Harrington, D. P.;Fleming, T. R.
  49. Biometrics v.46 Study duration and power consideration for clinical trials with survival response and early stopping Kim, K.;Tsiatis, A. A.
  50. Biometrics v.46 Implementation of group sequential logrank tests in a maximum duration trial Lan, K. K. G.;Lachin, J. M.
  51. Biometrics v.47 Repeated confidence intervals for a scale change in a sequential survival study Lin, D. Y.;Wei, L. J.
  52. Journal of Chronic Diseases v.27 Planning the size and duration of a clinical trial studying the time to some critical event George, S. L.;Desu, M. M.
  53. Journal of the Royal Statistical Society, Ser. B v.34 Regression models and life tables (with discussion) Cox, D. R.
  54. Statistics in Medicine v.6 Practical aspects in data monitoring: A brief review DeMets, D. L.
  55. Biometrika v.66 Sequential forms of the log rank and modified-Wilcoxon tests for censored data Jones, D.;Whitehead, J.
  56. Journal of the American Statistical Association v.88 Sequential analysis for censored regression data Gu, M.;Ying, Z.
  57. Biometrika v.72 Repeated confidence intervals for median survival time Jennison, C.;Turnbull, B. W.
  58. Journal of the American Statistical Association v.77 Two-sample repeated significance tests based on the modified Wilcoxon statistic Slud, E. V.;Wei, L. J.
  59. Statistics in Medicine v.13 Group sequential testing in clinical trials with multivariate observations: A review Lee, J. W.
  60. Controlled Clinical Trials v.5 Designs for group sequential tests Fleming, T. R.;Harrington, D. P.;O'Brien, P. C.
  61. Journal of Chronic Diseases v.24 Planning the duration of long-term survival time studies designed for accrual by cohorts Pasterack, B. S.;Gilbert, H. S.
  62. Counting Process and Survival Analysis Fleming, T. R.;Harrington, D. P.
  63. Statistics in Medicine v.1 Tables of the number of patients required in clinical trials using the logrank test Freedman, L. S.
  64. Journal of the Royal Statistical Society, Ser. A v.132 Repeated significance tests on accumulating data Armitage, P.;McPherson, C. K.;Rowe, B. C.