Planning and analyzing adaptive group sequential survival trials

Biometrical Journal

Volumn 48, Issue 4, 2006, Pages 714-729

  Wassmer, Gernot ^a  

^a UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

Author keywords

Adaptive design; Clinical trial; Group sequential test; Interim analysis; Log rank test; Survival analysis

Indexed keywords

MEDICAL APPLICATIONS;

ADAPTIVE DESIGNS; ADAPTIVE METHODS; AMOUNT OF INFORMATION; CLINICAL TRIAL; GROUP SEQUENTIAL TEST; INTERIM ANALYSIS; LOG-RANK TEST; RANK TEST; SEQUENTIAL TESTS; SURVIVAL ANALYSIS;

INVERSE PROBLEMS;

EID: 33748570462     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200510190     Document Type: Article

References (38)

1. Armitage, P., McPherson, C. K., and Rowe, B. C. (1969). Repeated significance tests on accumulating data. Journal of the Royal Statistical Society A 132, 235-244.
2. Bauer, P. (1989). Multistage testing with adaptive designs. Biometrie und Informatik in Medizin und Biologie 20, 130-148.
3. Bauer, P. and Posch, M. (2004). Letter to the Editor: Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 23, 1333-1335.
4. Brannath, W., Posch, M., and Bauer, P. (2002). Recursive combination tests. Journal of the American Statistical Association 97, 236-244.
5. Cui, L., Hung, H. M. J., and Wang, S.-J. (1999). Modification of sample size in group sequential clinical trials. Biometrics 55, 853-857.
6. Fairbanks, K. and Madsen, R. (1982). p-values for tests using a repeated significance test design. Biometrika 69, 69-74.
7. Fisher, L. D. (1998). Self-designing clinical trials. Statistics in Medicine 17, 1551-1562.
8. Freedman, L. S. (1982). Tables of the number of patients required in clinical trials using the logrank test. Statistics in Medicine 1, 121-129.
9. Hartung, J. and Knapp, G. (2003). A new class of completely self-designing clinical trials. Biometrical Journal 45, 3-19.
10. Hommel, G. (2001). Adaptive modifications of hypotheses after an interim analysis. Biometrical Journal 43, 581-589.
11. Houvelingen, v. H. C., Velde, v. d. C. J. H., and Stijnen, T. (2005). Interim analysis on survival data: Its potential bias and how to repair it. Statistics in Medicine 24, 2823-2835.
12. Hsieh, F. Y. (1992). Comparing sample size formulae for trials with unbalanced allocation using the logrank test. Statistics in Medicine 11, 1091-1098.
13. Jennison, C. and Turnbull, B. W. (1989). Interim analysis: the repeated confidence interval approach. Journal of the Royal Statistical Society B 51, 305-361.
14. Jennison, C. and Turnbull, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials. Chapman & Hall/CRC, Boca Raton, London, New York, Washington, D.C.
15. Jennison, C., and Turnbull, B. W. (2003). Mid-course sample size modification in clinical trial. Statistics in Medicine 22, 971-993.
16. Jones, D. and Whitehead, J. (1979). Sequential forms of the logrank and modified Wilcoxon tests for censored data. Biometrika 66, 105-133.
17. Kim, K. and Tsiatis, A. A. (1990). Study duration for clinical trials with survival response and early stopping rule. Biometrics 46, 81-92.
18. Lan, K. K. G. and DeMets, D. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70, 659-663.
19. Lawrence, J. (2002). Strategies for changing the test statistic during a clinical trial. Journal Biopharmaceutical Statistics 12, 193-205.
20. Lehmacher, W. and Wassmer, G. (1999). Adaptive sample size calculations in group sequential trials. Biometrics 55, 1286-1290.
21. Müller, H.-H. and Schäfer, H. (2001). Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches. Biometrics 57, 886-891.
22. Olschewski, M. and Schumacher, M. (1986). Sequential analysis of survival times in clinical trials. Biometrical Journal 28, 273-293.
23. Posch, M. and Bauer, P. (1999). Adaptive two stage designs and the conditional error function. Biometrical Journal 41, 689-696.
24. Posch, M., Timmesfeld, N., König, F., and Müller, H.-H. (2004). Conditional rejection probabilities of Student's t-test and design adaptation. Biometrical Journal 46, 389-403.
25. Proschan, M. A. and Hunsberger, S. A. (1995). Designed extension of studies based on conditional power. Biometrics 51, 1315-1324.
26. Schäfer, H. and Müller, H. H. (2001). Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 20, 3741-3751.
27. Schoenfeld, D. A. (1981). The asymptotic properties of nonparametric tests for comparing survival distributions. Biometrika 68, 316-319.
28. Sellke, T. and Siegmund, S. (1982). Sequential analysis of the proportional hazards model. Biometrika 70, 315-326.
29. Shen, Y. and Cai, J. (2003). Sample size re-estimation for clinical trials with censored survival data. Journal of the American Statistical Association 98, 418-426.
30. Shen, Y. and Fisher, L. (1999). Statistical inference for self-designing clinical trials with a one-sided hypothesis. Biometrics 55, 190-197.
31. Tsiatis, A. A. (1981). The asymptotic joint distribution of the efficient scores test for the proprtional hazards model calculated over time. Biometrika 68, 311-315.
32. Tsiatis, A. A. (1982). Repeated significance testing for a general class of statistics used in censored survival analysis. Journal of the American Statistical Association 77, 855-861.
33. Tsiatis, A. A., Rosner, G. L., and Mehta, C. R. (1984). Exact confidence intervals following a group sequential test. Biometrics 40, 797-803.
34. Wang, S. K. and Tsiatis, A. A. (1987). Approximately optimal one-parameter boundaries for group sequential trials. Biometrics 43, 193-199.
35. Wassmer, G. (1999). Statistische Testverfahren für gruppensequentielle und adaptive Pläne in klinischen Studien. Theoretische Konzepte und deren praktische Umsetzung mit SAS. Verlag Alexander Mönch, Köln.
36. Wassmer, G. (2003). Data-driven analysis strategies for proportion studies in adaptive group sequential test designs. Journal of Biopharmaceutical Statistics 13, 585-603.
37. Wassmer, G. and Eisebitt, R. (2005). ADDPLAN: Adaptive Designs - Plans and Analyses. Release 3. Software Documentation, http://www.addplan.com.
38. Wassmer, G., Eisebitt, R., and Coburger, S. (2001). Flexible interim analyses in clinical trials using multistage adaptive test designs. Drug Information Journal 35, 1131-1146.