Bayesian phase II adaptive randomization by jointly modeling time-to-event efficacy and binary toxicity

Lifetime Data Analysis

Volumn 17, Issue 1, 2011, Pages 156-174

  Lei, Xiudong ^a   Yuan, Ying ^a   Yin, Guosheng ^b  

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

^b UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

Adaptive randomization; Efficacy; Phase II trial; Survival analysis; Time to event endpoint; Toxicity

Indexed keywords

EID: 78651428711     PISSN: 13807870     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10985-010-9163-z     Document Type: Article

References (21)

1. Albert JH, Chib S (1993) Bayesian analysis of binary and polychotomous response data. J Am Stat Assoc 88: 669-679.
2. Berry DA, Eick SG (1995) Adaptive assignment versus balanced randomization in clinical trials: a decision analysis. Stat Med 14: 231-246.
3. Chang MN, Therneau TM, Wieand HS, Cha SS (1987) Designs for group sequential phase II clinical trials. Biometrics 43: 865-874.
4. Conaway MR, Petroni GR (1996) Designs for phase II trials allowing for a trade-off between response and toxicity. Biometrics 52: 1375-1386.
5. Cox DR (1972) Regression models and life-tables (with discussion). J R Stat Soc Ser B 34: 187-220.
6. Eick SG (1988) The two-armed bandit with delayed responses. Ann Stat 16: 254-264.
7. Eisele J (1994) The doubly adaptive biased coin design for sequential clinical trials. J Stat Plan Inference 38: 249-262.
8. Fleming TR (1982) One-sample multiple testing procedure for phase II clinical trials. Biometrics 38: 143-151.
9. Gehan EA (1961) The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chronic Dis 13: 346-353.
10. Hu F, Rosenberger WF (2006) The theory of response-adaptive randomization in clinical trials. Wiley, New York.
11. Louis TA (1977) Sequential allocation in clinical trials comparing two exponential survival curves. Biometrics 33: 627-634.
12. Ratain MJ, Sargent DJ (2009) Optimising the design of phase II oncology trials: the importance of randomisation. Eur J Cancer 45: 275-280.
13. Rosenberger WF (1996) New directions in adaptive designs. Stat Sci 11: 137-149.
14. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Controll Clin Trials 10: 1-10.
15. Thall PF, Cook JD (2004) Dose-finding based on efficacy-toxicity trade-offs. Biometrics 60: 684-693.
16. Thall PF, Wathen JK (2007) Practical Bayesian adaptive randomisation in clinical trials. Eur J Cancer 43: 859-866.
17. Wei LJ, Durham S (1978) The randomized play-the-winner rule in medical trials. J Am Stat Assoc 73: 840-843.
18. Yin G, Li Y, Ji Y (2006) Bayesian dose-finding in phase I/II clinical trials using toxicity and efficacy odds ratios. Biometrics 62: 777-787.
19. Yuan Y, Yin G (2009) Bayesian dose finding by jointly modeling toxicity and efficacy as time-to-event outcomes. J R Stat Soc Ser C 58: 719-736.
20. Zelen M (1969) Play the winner rule and the controlled clinical trial. J Am Stat Assoc 64: 131-146.
21. Zhang L, Rosenberger WF (2007) Response-adaptive randomization for survival trials: the parametric approach. Appl Stat 56: 153-165.