A Bayesian design for phase II clinical trials with delayed responses based on multiple imputation

Statistics in Medicine

Volumn 33, Issue 23, 2014, Pages 4017-4028

  Cai, Chunyan ^a   Liu, Suyu ^b   Yuan, Ying ^b  

^a UNIVERSITY OF TEXAS   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

continuous monitoring; delayed responses; multiple imputation

Indexed keywords

CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; EXPERIMENTAL THERAPY; HUMAN; MONITORING; PHASE 2 CLINICAL TRIAL; STUDY DESIGN;

EID: 85007042063     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6200     Document Type: Article

References (28)

1. Gehan EA. The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases 1961; 13: 346–353.
2. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143–151.
3. Simon RM. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989; 10: 1–10.
4. Green SJ, Dahlberg S. Planned versus attained design in phase II clinical trials. Statistics in Medicine 1992; 11: 853–862.
5. Chen TT. Optimal three-stage designs for phase II cancer clinical trials. Statistics in Medicine 1997; 16: 2701–2711.
6. Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Statistics in Medicine 1994; 13: 1727–1736.
7. Hanfelt JJ, Slack RS, Gehan EA. A modification of Simon's optimal design for phase II trials when the criterion is median sample size. Controlled Clinical Trials 1999; 20: 555–566.
8. Jung S-H, Carey M, Kim KM. Graphical search for two-stage designs for phase II clinical trials. Controlled Clinical Trials 2001; 22: 367–372.
9. Shuster J. Optimal two-stage designs for single arm phase II cancer trials. Journal of Biopharmaceutical Statistics 2002; 12: 39–51.
10. Lin Y, Shih WJ. Adaptive two-stage designs for single-arm phase IIA cancer clinical trials. Biometrics 2004; 60: 482–490.
11. Tan S-B, Machin D. Bayesian two-stage designs for phase II clinical trials. Statistics in Medicine 2002; 21: 1991–2012.
12. Sambucini V. A Bayesian predictive two-stage design for phase II clinical trials. Statistics in Medicine 2008; 27: 1199–1224.
13. Thall PF, Simon RM. Practical Bayesian guidelines for phase IIB clinical trials. Biometrics 1994; 50: 337–349.
14. Thall PF, Simon RM, Estey EH. Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Statistics in Medicine 1995; 14: 357–379.
15. Heitjan DF. Bayesian interim analysis of phase II cancer clinical trials. Statistics in Medicine 1997; 16: 1791–1802.
16. Lee JJ, Liu DD. A predictive probability design for phase II cancer clinical trials. Clinical Trials 2008; 5: 93–106.
17. Johnson VE, Cook JD. Bayesian design of single-arm phase II clinical trials with continuous monitoring. Clinical Trials 2009; 6: 217–226.
18. Wathen JK, Thall PF, Cook JD, Estey EH. Accounting for patient heterogeneity in phase II clinical trials. Statistics in Medicine 2008; 27: 2802–2815.
19. Zohar S, Teramukai S, Zhou Y. Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: a tutorial. Contemporary Clinical Trials 2008; 29: 608–616.
20. Yuan Y, Yin G. Robust EM continual reassessment method in oncology dose finding. Journal of the American Statistical Association 2011; 106: 818–831.
21. Follmann DA, Albert PS. Bayesian monitoring of event rates with censored data. Biometrics 1999; 55: 603–607.
22. Zhao L, Taylor JMG, Schuetze SM. Bayesian decision theoretic two-stage design in phase II clinical trials with survival endpoint. Statistics in Medicine 2012; 31: 1804–1820.
23. Cheung YK, Thall PF. Monitoring the rates of composite events with censored data in phase II clinical trials. Biometrics 2002; 58: 89–97.
24. Rubin DB. Multiple Imputation for Nonresponse in Surveys. John Wiley & Sons: New York, 1987.
25. Arjas E, Gasbarra D. Nonparametric Bayesian inference from right censored survival data, using the Gibbs sampler. Statistica Sinica 1994; 4: 505–524.
26. Aslanidou H, Dey DK, Sinha D. Bayesian analysis of multivariate survival data using Monte Carlo methods. Canadian Journal of Statistics 1998; 26: 38–48.
27. Agresti A. Categorical Data Analysis 3rd edition. John Wiley & Sons, Inc.: Hoboken, New Jersey, 2012.
28. Nelsen R. An Introduction to Copulas. Springer: New York, 1999.