A Bayesian dose finding design for dual endpoint phase I trials

Statistics in Medicine

Volumn 25, Issue 1, 2006, Pages 3-22

  Loke, Yee Chong ^a,b   Tan, Say Beng ^a,c   Cai, YiYu ^b   Machin, David ^a,c,d,e  

^a DIVISION OF MEDICAL ONCOLOGY   (Singapore)

^b NANYANG TECHNOLOGICAL UNIVERSITY   (Singapore)

^c Research Unit   (Singapore)

^d UNIVERSITY OF LEICESTER   (United Kingdom)

^e UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

Bayesian; Dirichlet distribution; Dose finding clinical trial; Utility

Indexed keywords

ANTIRETROVIRUS AGENT;

ALGORITHM; ARTICLE; BAYES THEOREM; CHILD; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE CALCULATION; DOSE RESPONSE; DRUG RESEARCH; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MULTIVARIATE ANALYSIS; OPTIMAL DRUG DOSE; PHASE 1 CLINICAL TRIAL; PROBABILITY; RELIABILITY; SENSITIVITY ANALYSIS; SIDE EFFECT; SIMULATION; STATISTICAL DISTRIBUTION; STATISTICAL MODEL;

ANTI-HIV AGENTS; BAYES THEOREM; CHILD; CLINICAL TRIALS, PHASE I; COMPUTER SIMULATION; HIV INFECTIONS; HUMANS; MAXIMUM TOLERATED DOSE; RESEARCH DESIGN; VIRAL LOAD;

EID: 31344433744     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2303     Document Type: Article

References (20)

1. Carter SK. Study design principles for the clinical evaluation of new drugs as developed by the chemotherapy programme of the National Cancer Institute. In The Design of Clinical Trials in Cancer Therapy, Staquet MJ (ed.). Futara Pub. Co.: Brussels, 1973; 242-289.
2. Lin Y, Shih WJ. Statistical properties of the traditional algorithm-based for phase I cancer clinical trials. Biostatistics 2001; 2:203-215.
3. Storer B. Design and analysis of phase I clinical trials. Biometrics 1989; 45:925-937.
4. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics 1990; 46:33-38.
5. Whitehead J, Brunier H. Bayesian decision procedures for dose determining experiments. Statistics in Medicine 1995; 14:885-893.
6. Whitehead J. Bayesian decision procedures with application to dose-finding studies. International Journal of Pharmaceutical Medicine 1997; 11:201-208.
7. Whitehead J, Williamson D. Bayesian decision procedures base on logistic regression models for dose-finding studies. Journal of Biopharmaceutical Statistics 1998; 8:445-467.
8. Zhou Y, Whitehead J. Practical implementation of Bayesian dose-escalation procedures. Drug Information Journal 2003; 37:45-59.
9. Thall PF, Russell KE. A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 1998; 54:251-264.
10. O'Quigley J, Hughes MD, Fenton T. Dose-finding design for HIV studies. Biometrics 2001; 57:1018-1029.
11. Braun T. The bivariate continual reassessment method: extending the CRM to phase I trials of two competing outcomes. Controlled Clinical Trials 2002; 23:240-256.
12. Gooley TA, Martin PJ, Fisher LD, Pettinger M. Simulation as a design tool for phase I/II clinical trials: an example from bone marrow transplantation. Controlled Clinical Trials 1994; 15:450-462.
13. Hardwick J, Meyer MC, Stout QF. Directed walk designs for dose-response problems with competing failure modes. Biometrics 2003; 59:229-236.
14. Edler L. Overview of phase I trials. In Handbook of Statistics in Clinical Oncology, John C (ed.). Marcel Dekker: New York, 2001; 1-34.
15. Korn EL, Midthune D, Chen TT, Rubinstein LV, Christian MC, Simon RM. A comparison of two phase I trial designs. Statistics in Medicine 1994; 13:1799-1806.
16. Goodman SN, Zahurak M, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Statistics in Medicine 1995; 14:1149-1161.
17. O'Quigley J, Shen LZ. Continual reassessment method: a likelihood approach. Biometrics 1996; 52:163-174.
18. Leung HY, Wang YG. Isotonic designs for phase I trials. Controlled Clinical Trials 2001; 22:126-138.
19. O'Quigley J, Reiner E. A stopping rule for the continual reassessment method. Biometrika 1998; 85:741-748.
20. O'Quigley J. Continual reassessment designs with early termination. Biostatistics 2002; 3:87-99.