Group sequential designs for monitoring survival probabilities

Biometrics

Volumn 52, Issue 3, 1996, Pages 1033-1041

  Lin, D Y ^a   Shen, L ^a   Ying, Z ^b   Breslow, N E ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b RUTGERS UNIVERSITY   (United States)

Author keywords

Censoring; Clinical trial; Data monitoring; Interim analysis; Kaplan Meier estimator; Nelson Aalen estimator

Indexed keywords

PROBABILITY DISTRIBUTIONS; STATISTICS;

ASYMPTOTIC JOINT DISTRIBUTIONS; CENSORING; CLINICAL TRIAL; DATA MONITORING; INTERIM ANALYSIS; KAPLAN-MEIER ESTIMATORS; NELSON-AALEN ESTIMATOR; SEQUENTIAL DESIGN; SURVIVAL PROBABILITIES; TIME POINTS;

MEDICAL APPLICATIONS;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; COVARIANCE; HUMAN; MAJOR CLINICAL STUDY; NEPHROBLASTOMA; PROBABILITY; RELAPSE; STATISTICAL ANALYSIS; SURVIVAL; TREATMENT FAILURE;

EID: 0029795144     PISSN: 0006341X     EISSN: None     Source Type: Journal    
DOI: 10.2307/2533064     Document Type: Article

References (25)

1. Bie, O., Borgan, Ø., and LiestØl, K. (1987), Confidence intervals and confidence bands for the cumulative hazard rate function and their small sample properties. Scandinavian Journal of Stattstics 14, 221-233.
2. Bilias. Y., Gu, M., and Ying, Z. (1996). Towards a general asymptotic theory for Cox model with staggered entry. The Annals of Statistics, in press.
3. Breslow, N. and Crowley, J. (1974). A large sample study of the life table and product limit estimates under random censorship. The Annals of Statistics 2, 437-453.
4. Connor, E. M., Sperling, R. S., Gelber, R., et al. (1994). Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. New England Journal of Medicine 331, 1173-1180.
5. D'Angio, G. J., Breslow, N., Beckwith, J. B., et al. (1989). The treatment of Wilms' tumor: Results of the Third National Wilms Tumor Study. Cancer 64, 349-360.
6. Fleming, T. R. and Harrington, D. P. (1991). Counting Processes and Survival Analysis. New York: Wiley.
7. Gu, M. G. and Lai, T. L. (1991). Weak convergence of time-sequential censored rank statistics with applications to sequential testing in clinical trials. The Annals of Statistics 19, 1403-1433.
8. Harris, J. R. and Hellman, S. (1986). Observations on survival curve analysis with particular reference to breast cancer treatment. Cancer 57, 925-928.
9. Jones, D. and Whitehead, J. (1979). Sequential forms of the log rank and modified Wilcoxon tests for censored data. Biometrika 66, 105-113. Corrections, 68, 576.
10. Kalbfleisch, J. D. and Prentice, R. L. (1980). The Statistical Analysts of Failure Time Data. New York: Wiley.
11. Kim, K. and DeMets, D. L. (1937). Design and analysis of group sequential tests based on the type I error spending rate function. Biometrika 74, 149-154.
12. Lan, K. K. G. and DeMets, D. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70, 659-663.
13. Lee, J. W. and Sather, H. N. (1995). Group sequential methods for comparison of cure rates in clinical trials. Biometrics 51, 756-763.
14. Lin, D. Y. (1991). Nonparametric sequential testing in clinical trials with incomplete multivariate observations. Biometrika 78, 123-131.
15. Lin, D. Y., Fleming, T. R., and Wei, L. J. (1994). Confidence bands for survival curves under the proportional hazards model. Biometrika 81, 73-81.
16. O'Brien, P. C. and Fleming, T. R. (1979). A multiple testing procedure for clinical trials. Biometrics 35, 549-556.
17. Pocock, S. J. (1977). Group sequential methods in the design and analysis of clinical trials. Biometrika 64, 191-199.
18. Pollard, D. (1990). Empirical Processes: Theory and Applications. Hayward, California: Institute of Mathematical Statistics.
19. Schervish, M. J. (1984). Multivariate normal probabilities with error bound. Applied Statistics 33, 81-94. Corrections, 34, 103-104.
20. Siegmund, D. (1985). Sequential Analysts: Tests and Confidence Intervals. New York: Springer-Verlag.
21. Slud, E. V. (1984). Sequential linear rank tests for two-sample censored survival data. The Annals of Statistics 12, 551-571.
22. Slud, E. and Wei, L. J. (1982). Two-sample repeated significance tests based on the modified Wilcoxon statistic. Journal of the American Statistical Association 77, 862-868.
23. Su, J. Q. and Lachin, J. M. (1992). Group-sequential distribution-free methods for the analysis of multivariate observations. Biometrics 48, 1033-1042.
24. 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.
25. Whitehead, J. (1983). The Design and Analysis of Sequential Clinical Trials. New York: Ellis Horwood.