Operating characteristics of the standard phase I clinical trial design

Computational Statistics and Data Analysis

Volumn 30, Issue 3, 1999, Pages 303-315

  Reiner, Ethan ^a   Paoletti, Xavier ^a   O'Quigley, John ^a  

^a INSERM   (France)

Author keywords

Allocation schemes; Phase I trials; Standard phase I design; Stopping rules; Up and Down

Indexed keywords

ERROR ANALYSIS; HEALTH RISKS; PROBABILITY;

STOPPING RULES;

STATISTICAL METHODS;

EID: 0032648126     PISSN: 01679473     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0167-9473(98)00095-4     Document Type: Article

References (17)

1. Bolognese J.A. A Monte-Carlo comparison of 3 up and down designs. Controlled Clin. Trials. 4(3):1983;187-196.
2. Dixon W.J., Mood A.M. A method for obtaining and analyzing sensitivity data. J. Amer. Statist. Assoc. 43:1948;109-126.
3. Durham, S.D., Flournoy, N., 1994. Random walks for quantile estimation. In: Berger, J., Gupta, S. (Eds.), Statistical Decision Theory and Related Topics V. Springer, New York, pp. 467-476.
4. Durham, S.D., Flournoy, N., 1995. Up-and-down designs I: Stationary treatment distributions. In: Flournoy, N., Rosenberg, W.F. (Eds.), Adaptive Designs, IMS Lecture Notes Monograph Series. Institute of Mathematical Statistics, Hayward, CA.
5. Durham, S.D., Flournoy, N., Montazer-Haghighi, A.A., 1995. Up-and-down designs II: exact treatment moments. In: Flournoy, N., Rosenberg, W.F. (Eds.), Adaptive Designs, IMS Lecture Notes Monograph Series. Institute of Mathematical Statistics, Hayward, CA.
6. Durham S.D., Flournoy N., Rosenberger W.F. A random walk rule for phase I clinical trials. Biometrics. 53:1997;745-760.
7. Faries, D., 1991. The modified continual reassessment method for phase I clinical trials. Proc. Biopharmaceutical Section, American Statistical Association, pp. 269-273.
8. Geller N.L. Design of phase I and II clinical trials in cancer: a statisticians view. Cancer Investigation. 2:1984;483-491.
9. Korn E.L., Midthune D., Chen T.T., Rubinstein L.V., Christian M.C., Simon R. A comparison of phase I trial designs. Statist. Med. 13:1994;1799-1806.
10. Möller, S., 1995. An extension of the continual reassessment method using preliminary up-and-down design in a dose finding study in cancer patients, in order to investigate a greater range of doses. Statist. Med. 14 (9-10), 911-922.
11. O'Quigley, J., Pepe, M., Fisher, L., 1990. Continual reassessment method: a practical design for phase I clinical studies in cancer. Biometrics 46, 33-48.
12. O'Quigley, J., Reiner, E., 1998. A stopping rule for the continual reassessment method. Biometrika 85, 741-748.
13. O'Quigley, J., Shen, L.Z., 1996. Continual reassessment method: a likelihood approach. Biometrics 52, 673-684.
14. Smith T.L., Lee J.J., Kantarjian H.M., Legha S.S., Raber M.N. Design and results of phase I cancer clinical trials: three year experience at M.D. Anderson Cancer Center. J. Clin. Oncol. 14(1):1996;287-295.
15. Storer B.E. Design and analysis of phase I clinical trials. Biometrics. 45:1989;925-937.
16. Storer B.E. Small-sample confidence sets for the MTD in a phase I clinical trial. Biometrics. 49:1993;1117-1125.
17. Wetherill G.B. Sequential estimation of quantal response curves. J. Roy. Statist. Soc. Ser. B. 25:1963;1-48.