Practical Implementation of Bayesian Dose-Escalation Procedures

Drug Information Journal

Volumn 37, Issue 1, 2003, Pages 45-59

  Zhou, Yinghui ^a   Whitehead, John ^a  

^a UNIVERSITY OF READING   (United Kingdom)

Author keywords

Bayesian statistics; Computer software; Decision procedure; Dose escalation; Phase 1 study

Indexed keywords

BAYES THEOREM; DOSE RESPONSE; LOGISTIC REGRESSION ANALYSIS; PRIORITY JOURNAL; REVIEW; SAFETY; SIMULATION; TOXICITY TESTING;

EID: 0142153227     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150303700108     Document Type: Review

References (21)

1. Whitehead J, Brunier H. Bayesian decision procedures for dose determining experiments. Stat Med. 1995;14:885-893.
2. Whitehead J, Williamson D. An evaluation of Bayesian decision procedures for dose-finding studies. J Biopharma Stat. 1998;8:445-467.
3. Judson IR. Evaluation of new anticancer drugs. In Horwich A, ed. Oncology: Multidisciplinary Textbook. London, United Kingdom: Chapman and Hall; 1995:147-159.
4. Carter SK. Study design principles in the clinical evaluation of new drugs as developed by the chemotherapy programme of the National Cancer Institute. In: Staquet MJ, ed. The Design of Clinical Trials in Cancer Therapy. Brussels, Belgium: Editions Scientific Europe; 1973:242-289.
5. Whitehead J. Bayesian decision procedures with application to dose-finding studies. Int J Pharma Med. 1997;11:201-208.
6. Lin Y, Shih WJ. Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials. Biostatistics. 2001;2:203-215.
7. O'Quigley J, Pepe M, Fisher L. Continual Reassessment Method: a practical design for phase I clinical trials in cancer. Biometrics. 1990;46:33-48.
8. Korn EL, Midthune D, Chen TT, Rubinstein LV, Christian MC, and Simon RM. A comparison of two phase I designs. Stat Med. 1994;13:1799-1806.
9. Faries D. Practical modifications of the continual reassessment method for phase I cancer clinical trials. J Biopharma Stat. 1994;4:147-164.
10. Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995;14:1149-1161.
11. O'Quigley J, Shen LZ. Continual reassessment method: a likelihood approach. Biometrics. 1996;52:673-684.
12. O'Quigley J. Dose-finding design using continual reassessment method. In: Crowley, J, ed. Handbook of Statistics in Clinical Oncology. New York, NY: Dekker; 2001:35-72.
13. Heyd JM, Carlin BP. Adaptive design improvements in the continual reassessment method for phase I studies. Stat Med. 1999;18:1307-1321.
14. O'Quigley J, Reiner E. A stopping rule for the continual reassessment method. Biometrika. 1998;85:741-748.
15. O'Quigley J. Continual reassessment designs with early termination. Biostatistics. 2002;3:87-99.
16. Ferry DR, Smith A, Malkhandi J, Fyfe DW, de-Takats PG, Anderson D, Baker J, Kerr DJ. Phase I clinical trial of the flavonoid quercetin-pharmacokinetics and evidence for in vivo tyrosine kinase inhibition. Clin Cancer Research. 1996;2:659-668.
17. Piantadosi S, Liu G. Improved designs for dose escalation studies using pharmacokinetic measurements. Stat Med. 1996;15:1605-1618.
18. Wang O, Faries DE. A two-stage dose selection strategy in phase I trials with wide dose ranges. J Biopharma Stat. 2000;10:319-333.
19. Babb J, Rogatko A, Zacks S. Cancer phase I clinical trials: efficient dose escalation with overdose control. Stat Med. 1998;17:1103-1120.
20. Gasparini M, Eisele J. A curve-free method for phase I clinical trials. Biometrics. 2000;56:609-615.
21. Zhou Y, Whitehead J. Bayesian ADEPT: Operating Manual. Reading, United Kingdom: The University of Reading; 2002.