Design of group sequential clinical trials with multiple endpoints

Journal of the American Statistical Association

Volumn 84, Issue 407, 1989, Pages 775-779

  Tang, Dei In ^a   Gnecco, Clare ^b   Geller, Nancy L ^b  

^a NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Clinical trial design; Interim analysis; Multiplicity; O Brien s statistic; Repeated significance testing

Indexed keywords

EID: 84950421583     PISSN: 01621459     EISSN: 1537274X     Source Type: Journal    
DOI: 10.1080/01621459.1989.10478836     Document Type: Article

References (11)

1. Fleiss, J. (1981), Statistical Methods for Rates and Proportions (2nd ed.), New York: John Wiley.
2. Fleming, T. R., Harrington, D. R, and O’Brien, P. C. (1984), “Designs for Group Sequential Tests,” Controlled Clinical Trials, 5, 348–361.
3. Geller, N. L., and Pocock, S. J. (1987), “Interim Analyses in Randomized Clinical Trials: Ramifications and Guidelines for Practitioners,” Biometrics, 43, 213–224.
4. —— (1988), “Design and Analysis of Clinical Trials With Group Sequential Stopping Rules,” in Biopharmaceutical Statistics for Drug Development, ed. K. E. Peace, New York: Marcel Dekker, pp. 489–508.
5. Lan, K. K. G., and DeMets, D. L. (1983), “Discrete Sequential Boundaries for Clinical Trials,” Biometrika, 70, 659–663.
6. O’Brien, P. C. (1984), “Procedures for Comparing Samples With Multiple Endpoints,” Biometrics, 40, 1079–1087.
7. O’Brien, P. C., and Fleming, T. R. (1979), “A Multiple Testing Procedure for Clinical Trials,” Biometrics, 35, 549–556.
8. Pocock, S. J. (1977), “Group Sequential Methods in the Design and Analysis of Clinical Trials,” Biometrika, 64, 191–199.
9. —— (1982), “Interim Analyses for Randomized Clinical Trials: The Group Sequential Approach,” Biometrics, 38, 153–162.
10. Pocock, S. J., Geller, N. L., and Tsiatis, A. A. (1987), “The Analysis of Multiple Endpoints in Clinical Trials,” Biometrics, 43, 487–498.
11. Press, S. J. (1972), Applied Multivariate Analysis, New York: Holt, Rinehart & Winston.