A Bayesian predictive two-stage design for phase II clinical trials

Statistics in Medicine

Volumn 27, Issue 8, 2008, Pages 1199-1224

  Sambucini, Valeria ^a  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

Analysis and design priors; Bayesian approach; Prior predictive distributions; Sample size determination; Two stage design

Indexed keywords

GEMCITABINE;

ARTICLE; BAYES THEOREM; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DATA ANALYSIS; DRUG EFFICACY; HUMAN; INFORMATION PROCESSING; MATHEMATICAL ANALYSIS; MATHEMATICAL COMPUTING; MEDICAL LITERATURE; METHODOLOGY; NASOPHARYNX CANCER; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PREDICTION; PROBABILITY; SAMPLE SIZE; TREATMENT OUTCOME;

BAYES THEOREM; CLINICAL TRIALS, PHASE II AS TOPIC; HUMANS; MODELS, STATISTICAL; NASOPHARYNGEAL NEOPLASMS; PREDICTIVE VALUE OF TESTS; PROBABILITY; RESEARCH DESIGN; SAMPLE SIZE; UNCERTAINTY;

EID: 40849145660     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3021     Document Type: Article

References (17)

1. Gehan EA. The determination of the number of patients required in a preliminary and follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases 1961; 13:346-353.
2. Simon R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989; 10:1-10.
3. Sylvester RJ. A Bayesian approach to the design of phase II clinical trials. Biometrics 1988; 44:823-836.
4. Stallard N. Sample size determination for phase II clinical trials based on Bayesian decision theory. Biometrics 1998; 54:279-294.
5. Stallard N, Thall PF, Whitehead J. Decision theoretic designs for phase II clinical trials with multiple outcomes. Biometrics 1999; 55:971-977.
6. Jung SH, Lee T, Kim KM, George SL. Admissible two-stage designs for phase II cancer clinical trials. Statistics in Medicine 2004; 23:561-569. DOI: 10.1002/sim.1600.
7. Herson J. Predictive probability early termination for phase II clinical trials. Biometrics 1979; 35:775-783.
8. Heitjan DF. Bayesian interim analysis of phase II cancer clinical trials. Statistics in Medicine 1997; 16:1791-1802.
9. Tan SB, Machin D. Bayesian two-stage designs for phase II clinical trials. Statistics in Medicine 2002; 21: 1991-2012. DOI: 10.1002/sim.1176.
10. Mayo MS, Gajewski BJ. Bayesian sample size calculations in phase II clinical trials using informative conjugate priors. Controlled Clinical Trials 2004; 25:157-167.
11. Gajewski BJ, Mayo MS. Bayesian sample size calculations in phase II clinical trials using a mixture of informative priors. Statistics in Medicine 2006; 25:2554-2566. DOI: 10.1002/sim.2450.
12. Wang YG, Leung DH, Li M, Tan SB. Bayesian designs with frequentist and Bayesian error rate considerations. Statistical Methods in Medical Research 2005; 14(5):445-456.
13. Wang F, Gelfand AE. A simulation-based approach to Bayesian sample size determination for performance under a given model and for separating models. Statistical Science 2002; 17(2):193-208.
14. De Santis F Sample size determination for robust Bayesian analysis. Journal of the American Statistical Association 2006; 101(473):278-291.
15. Gelman A, Carlin JB, Stern HS, Rubin DB. Bayesian Data Analysis. Chapman & Hall: New York, 2000.
16. Sahu SK, Smith TMF. A Bayesian method of sample size determination with practical applications. Journal of the Royal Statistical Society, Series A 2006; 169:235-253.
17. Foo KF, Tan EH, Leong SS, Wee JTS, Tan T, Fong KW, Koh L, Tai BC, Lian LG, Machin D. Gemcitabine in metastatic nesopharyngeal carcinoma of the undifferentiate type. Annals of Oncology 2002; 13(1): 150-156.