Between-arm comparisons in randomized phase ii trials

Journal of Biopharmaceutical Statistics

Volumn 19, Issue 3, 2009, Pages 456-468

  Jung, Sin Ho ^a   George, Stephen L ^a  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Pick the winner; Two stage design; Type I error; Type II error; Uniformly minimum variance unbiased estimator

Indexed keywords

ARTICLE; BETWEEN ARM COMPARISON METHOD; CLINICAL EVALUATION; DRUG EFFICACY; EXPERIMENTAL DESIGN; HUMAN; METHODOLOGY; PRIORITY JOURNAL; PROBABILITY; SAMPLE SIZE; STATISTICS; COMPARATIVE STUDY; CONTROL GROUP; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

CLINICAL TRIALS, PHASE II AS TOPIC; CONTROL GROUPS; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 67651024031     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400902802391     Document Type: Article

References (16)

1. Beckhofer, R. E. (1954). A single-sample multiple decision procedure for ranking means of normal populations with known variances. Ann. Math. Stat. 25:16-39.
2. Berger, R., Boos, D. D. (1994). P values maximized over a confidence set for the nuisance parameter. J. Am. Stat. A. 89:1012-1016.
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. Cheung, Y. K. (2008). Simple sequential boundaries for treatment selection in multi-armed randomized clinical trials with a control. Biometrics 64:940-949.
5. Jung, S. H. (2007). Randomized Phase II trials with a prospective control. Stat. Med. 27: 568-583.
6. Jung, S. H., Carey, M., Kim, K. M. (2001). Graphical search for two-stage designs for Phase II clinical trials. Contr. Clin. Trials 22:367-372.
7. Jung, S. H., Kim, K. M. (2004). On the estimation of the binomial probability in multistage clinical trials. Stat. Med. 23:881-896.
8. Jung, S. H., Lee, T. Y., Kim, K. M., George, S. L. (2004). Admissible two-stage designs for Phase II cancer clinical trials. Stat. Med. 23:561-569.
9. Liu, P. Y., LeBlanc, M., Desai, M. (1999). False positive rates of randomized Phase II designs. Contr. Clin. Trials 20:343-352.
10. Palmer, C. R. (1991). A comparative Phase II clinical trials procedure for choosing the best of three treatments. Stat. Med. 10:1327-1340.
11. Sargent, D. J., Goldberg, R. M. (2001). A flexible design for multiple armed screening trials. Stat. Med. 20:1051-1060.
12. Simon, R. (1989). Optimal two-stage designs for Phase II clinical trials. Contr. Clin. Trials 10:1-10.
13. Simon, R., Wittes, R. E., Ellenberg, S. S. (1985). Randomized Phase II clinical trials. Cancer Treatment Reports 69:1375-1381.
14. Spiegelhalter, D. J., Freedman, L. S., Blackburn, P. R. (1986). Monitoring clinical trials: Conditional or predictive power? Contr. Clin. Trials 7:8-17.
15. Steinberg, S. M., Venzon, D. J. (2002). Early selection in a randomized Phase II clinical trial. Stat. Med. 21:1711-1726.
16. Thall, P. F., Simon, R., Ellenburg, S. S. (1989). A two-stage design for choosing among severval experimental treatments and a control in clinical trials. Biometrics 45:537-547.