p-value calculation for multistage Phase II cancer clinical trials

Journal of Biopharmaceutical Statistics

Volumn 16, Issue 6, 2006, Pages 765-775

  Jung, Sin Ho ^a,c   Owzar, Kouros ^a   George, Stephen L ^a   Lee, Taiyeong ^b  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b SAS INSTITUTE INC   (United States)

^c CALGB Statistical Center   (United States)

Author keywords

Confidence interval; Likelihood ratio ordering; MLE; Stochastic ordering; UMVUE

Indexed keywords

ARTICLE; BINOMIAL DISTRIBUTION; CALCULATION; CANCER RESEARCH; METHODOLOGY; OUTCOME VARIABLE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RESEARCH ETHICS; STATISTICAL MODEL; STATISTICAL SIGNIFICANCE;

ALGORITHMS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE II; ENDPOINT DETERMINATION; HUMANS; LIKELIHOOD FUNCTIONS; NEOPLASMS; RESEARCH DESIGN; STOCHASTIC PROCESSES; TREATMENT OUTCOME;

EID: 33751084330     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400600825645     Document Type: Article

References (17)

1. Armitage, P. (1958). Numerical studies in the sequential estimation of a binomial parameter. Biometrika 45:1-15.
2. Chang, M. N., O'Brien, P. C. (1985). Confidence intervals following group sequential trials. Controlled Clinical Trials 7:18-26.
3. Chang, M. N., Therneau, T. M., Wieand, H. S., Cha, S. S. (1987). Designs for group sequential Phase II clinical trials. Biometrics 43:865-874.
4. Chang, M. N., Wieand, H. S., Chang, V. T. (1989). The bias of the sample proportion following a group sequential phase II clinical trials. Statistics in Medicine 8:563-570.
5. Chang, M. N., Gould, A. L., Snapinn, S. M. (1995). P-values for group sequential testing. Biometrika 82:650-654.
6. Cook, T. D. (2002). P-value adjustment in sequential clinical trials. Biometrics 58:1005-1011.
7. Emerson, S. S., Fleming, T. R. (1990). Parameter estimation following group sequential hypothesis testing. Biometrika 77:875-892.
8. Girshick, M. A., Mosteller, F., Savage, L. J. (1946). Unbiased estimates for certain binomial sampling problems with application. Annals of Mathematical Statistics 17:13-23.
9. Jennison, C., Turnbull, B. W. (1983). Confidence intervals for a binomial parameter following a multistage test with application to MIL-STD 105D and medical trials. Technometrics 25:49-58.
10. Jung, S. H., Kim, K. M. (2004). On the estimation of the binomial probability in multistage clinical trials. Statistics in Medicine 23:881-896.
11. Jung, S. H., Carey, M., Kim, K. M. (2001). Graphical search for two-stage designs for phase II clinical trials. Controlled Clinical Trials 22:367-372.
12. Jung, S. H., Lee, T. Y., Kim, K. M., George, S. (2004). Admissible two-stage designs for Phase II cancer clinical trials. Statistics in Medicine 23:561-569.
13. Lehmann, E. L. (1983). Theory of Point Estimation. New York: Wiley.
14. Schultz, J. R., Nichol, F. R., Elfring, G. L., Weed, S. D. (1973). Multistage procedures for drug screening. Biometrics 29:293-300.
15. Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 10:1-10.
16. Tsiatis, A. A., Rosner, G. L., Mehta, C. R. (1984). Exact confidence intervals following a group sequential test. Biometrics 40:797-803.
17. Whitehead, J. (1986). On the bias of maximum likelihood estimation following a sequential test. Biometrika 73:573-581.