Designing phase II studies in cancer with time-to-event endpoints

Clinical Trials

Volumn 5, Issue 3, 2008, Pages 209-221

  Owzar, Kouros ^a   Jung, Sin Ho ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; ARTICLE; BINOMIAL DISTRIBUTION; CANCER SURVIVAL; CLINICAL RESEARCH; COMPUTER SIMULATION; MALIGNANT NEOPLASTIC DISEASE; MATHEMATICAL COMPUTING; NONPARAMETRIC TEST; PARAMETRIC TEST; PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL MODEL; BIOASSAY; HUMAN; METHODOLOGY; NEOPLASM; PHASE 2 CLINICAL TRIAL; SURVIVAL;

CLINICAL TRIALS, PHASE II AS TOPIC; COMPUTER SIMULATION; ENDPOINT DETERMINATION; HUMANS; MODELS, STATISTICAL; NEOPLASMS; RESEARCH DESIGN; SURVIVAL ANALYSIS;

EID: 54549105379     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774508091748     Document Type: Article

References (26)

1. Nelson W. Theory and applications of hazard plotting for censored failure data. Technometrics 1972; 14: 945-66.
2. Aalen O. Nonparametric inference for a family of counting processes. The Annals of Statistics. 1978; 6: 701-26.
3. Brown BW, Brauner C., Chan A., et al. DSTPLAN: Calculations for Sample Sizes and Related Problems User's Guide. 2005; Available from: http://biostatistics.mdanderson.org/SoftwareDownload/
4. Brookmeyer R., Crowley JJ A confidence interval for the median survival time. Biometrics 1982; 28: 29-41.
5. R Development Core Team. R Foundation for Statistical Computing. R: A Language and Environment for Statistical Computing. 2007; ISBN 3-900051-07-0. Available from: http://www.R-project.org
6. Armitage P. Numerical studies in the sequential estimation of a binomial parameter. Biometrika 1958; 45(1-2): 1-15.
7. Fleming TR One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38(1): 143-51.
8. Simon R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989; 10(1): 1-10.
9. Jung SH, Carey M., Kim K. Graphical search for two-stage designs for phase II clinical trials. Controlled Clinical Trials 2001; 22(4): 367-72.
10. Jung SH, Kim KM On the estimation of the binomial probability in multistage clinical trials. Statistics in Medicine 2004; 23(6): 881-96.
11. Jung SH, Owzar K., George SL, Lee T. P-value calculation for multistage phase II cancer clinical trials. Journal of Biopharmaceutical Statistics 2006; 16(6): 765-75; discussion 777-83.
12. Lin DY, Shen L., Ying Z., Breslow NE Group sequential designs for monitoring survival probabilities. Biometrics 1996; 52(3): 1033-41.
13. Case DL, Morgan TM Design of Phase II cancer trials evaluating survival probabilities. BMC Medical Research Methodology 2003; 3(6).
14. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemotherapy Reports 1966; 50(3): 163-70.
15. Cantor AB Sample size calculations for the log rank test: A gompertz model approach. Journal of Clinical Epidemiology 1992; 45(11): 1131-36.
16. Cantor AB Power calculation for the log rank test using historical data. Controlled Clinical Trials 1996; 17(2): 111-16.
17. Jennrich RI A note on the behavior of the log rank permutation test under unequal censoring. Biometrika 1983; 70: 133-37.
18. Jennrich RI Some exact tests for comparing survival curves in the presence of unequal right censoring. Biometrika 1984; 71: 57-64.
19. Heinze G., Gnant M., Schemper M. Exact log-rank tests for unequal follow-up. Biometrics 2003; 59(4): 1151-57.
20. Ratain MJ, Karrison TG Testing the wrong hypothesis in phase II oncology trials: There is a better alternative. Clinical Cancer Research 2007; 13(3): 781-82. AvaHlable from: http://dx.doi.org/10.1158/ 1078-0432.CCR-06-2533
21. Jung SH Randomized phase II trials with prospective control. Technical Report. Department of Biostatistics and Bioinformatics, Duke University, 2007.
22. ox DR, Oakes D. Analysis of Survival Data. Chapman & Hall Ltd, 1984.
23. Sprott DA Normal likelihoods and their relation to large sample theory of estimation. Biometrika 1973; 60: 457-65.
24. Lawless JF Statistical Models and Methods For Lifetime Data. John Wiley & Sons, New York, 1982.
25. Abramowitz M., Stegun IA Handbook of Mathematical Functions with Formulas, Graphs, and Mathematical Tables. Dover, New York, 1964.
26. Brookmeyer R., Crowley JJ A confidence interval for the median survival time. Biometrics 1982; 28: 29-41.