Dose-Escalation with Overdose Control

Statistical Methods for Dose-Finding Experiments

Volumn , Issue , 2006, Pages 173-188

  Tighiouart, Mourad ^a   Rogatko, André ^a  

^a EMORY UNIVERSITY   (United States)

Author keywords

Adjusting for covariates; Choice of prior distributions; Dose escalation with overdose control; Dose limiting toxicity (DLT); Escalation with overdose control (EWOC); EWOC and cancer phase I clinical trial; EWOC and MTD; Maximum tolerated dose (MTD)

Indexed keywords

CLINICAL TRIAL; COVARIATES; DOSE ESCALATION; DOSE LIMITING TOXICITY; ESCALATION WITH OVERDOSE CONTROL (EWOC); EWOC AND MTD; MAXIMUM TOLERATED DOSE; PRIOR DISTRIBUTION;

EID: 84866855973     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/0470861258.ch8     Document Type: Chapter

References (24)

1. P.V. Wooley and P.S. Schein (1979) Clinical pharmacology and phase I trial design, in Methods of Cancer Research (eds V. de Vita and H. Busch), Academic Press, New York, pp. 177-98.
2. C. Gatsonis and J.B. Greenhouse (1992) Bayesian methods for phase I clinical trials. Statistics in Medicine, 11(10), 1377-89.
3. B.E. Storer (1989) Design and analysis of phase I clinical trial. Biometrics, 45(3), 925-37.
4. S.D. Durham and N. Flournoy (1994) Random walks for quantile estimation, in Statistical Design Theory and Related Topics V (eds S.S. Gupta and J.O. Berger), Springer, New York, pp. 467-76.
5. M. Gasparini and J. Eisele (2000) A curve-free method for phase I clinical trials. Biometrics, 56(2), 609-15.
6. R.K. Tsutakawa (1972) Design of experiment for bioassay. J. Am. Statistical Assoc., 67, 584-90, 2183-96.
7. R.K. Tsutakawa (1980) Selection of dose levels for estimating a percentage point on a logistic quantal response curve. Appl. Statistics, 29, 25-33.
8. A.P. Grieve (1987) A Bayesian approach to the analysis of LD50 experiments. Technical report 8708, CIBA-GEIGY AG.
9. A. Racine, A.P. Grieve,H. Fluehler and A.F.M. Smith (1986) Bayesian methods in practice: experiences in the pharmaceutical industry. Appl. Statistics, 35, 93-150.
10. J. O'Quigley, M. Pepe and L. Fisher (1990) Continual reassessment method: a practical design for phase I clinical trials in cancer, Biometrics, 46(1), 33-48.
11. J. Babb, A. Rogatko and S. Zacks (1998) Cancer phase I clinical trials: efficient dose escalation with overdose control. Statistics in Medicine, 17(10), 1103-20.
12. J. Whitehead and H. Brunier (1995) Bayesian decision procedures for dose determining experiments. Statistics in Medicine, 14(9), 885-93.
13. L.M. Haines, I. Perevozskaya and W.F. Rosenberger (2003) Bayesian optimal designs for phase I clinical trials. Biometrics, 59(3), 591-600.
14. W.F. Rosenberger and L.M. Haines (2002) Competing designs for phase I clinical trials: a review. Statistics in Medicine, 21(18), 2757-70.
15. J. Babb and A. Rogatko (2001) Patient specific dosing in a cancer phase I clinical trial. Statistics in Medicine, 20(14), 2079-90.
16. J. Cheng, J.S. Babb, C. Langer, S. Aamdal, F. Robert, L.R. Engelhardt, O. Fernberg, J. Schiller, G. Forsberg, R.K. Alpaugh, L.M. Weiner and A. Rogatko (2004) Individualized patient dosing in phase I clinical trials: the role of escalation with overdose control in PNU-214936. J. Clin. Oncology, 22(4), 602-9.
17. B.H. Eichhorn and S. Zacks (1973) Sequential search of an optimal dosage, I. J. Am. Statistical Assoc., 68, 594-8.
18. A. Rogatko, M., Tighiouart and X. Zhiheng (2005) EWOC 2.0 application software. Winship Cancer Institute, Emory University. Atlanta, Georgia. http://sisyphus.emory.edu/ ewoc.html.
19. G. Decoster, G. Stein and E.E. Holdener (1989) Responses and toxic deaths in phase I clinical trials, in Sixth NCI-EORTC Symposium on New Drugs in Cancer Therapy, Amsterdam, 1989, pp. 175-81.
20. M.J. Ratain, R. Mick, R.L. Schilsky and M. Siegler (1993) Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J. Natl Cancer Inst., 85(20), 1637-43.
21. D.J. Spiegelhalter, A. Thomas and N.G. Best (1999) WinBUGS Version 1.2 User Manual, MRC Biostatistics Unit.
22. M. Tighiouart, A. Rogatko and J.S. Babb (2005) Flexible Bayesian methods for cancer phase I clinical trials: dose escalation with overdose control. Statistics in Medicine, 24, 2183-2196.
23. N. Metropolis, A.W. Rosenbluth, M.N. Rosenbluth, A.H. Teller and E. Teller (1953) Equation of state calculations by fast computing machines. J. Chem. Physics, 21, 1087-92.
24. W.K. Hastings (1970) Monte Carlo sampling methods using Markov chains and their applications. Biometrika, 57, 97-109.