Dose-finding designs: The role of convergence properties

International Journal of Biostatistics

Volumn 7, Issue 1, 2011, Pages

  Oron, Assaf P ^a   Azriel, David ^b   Hoff, Peter D ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b HEBREW UNIVERSITY OF JERUSALEM   (Israel)

Author keywords

adaptive designs; continual reassessment method; cumulative cohort design; dose finding; item response theory; phase I clinical trials; sensory studies; up and down

Indexed keywords

ALGORITHM; ARTICLE; COHORT ANALYSIS; CONCEPTUAL FRAMEWORK; CONTINUAL REASSESSMENT METHOD; DOSE CALCULATION; DRUG SAFETY; HUMAN; INTERVAL DESIGN METHOD; PHASE 1 CLINICAL TRIAL (TOPIC); SAMPLE SIZE; SENSITIVITY ANALYSIS; STUDY DESIGN; TECHNIQUE; CLINICAL TRIAL; DOSE RESPONSE; NEOPLASM; PHASE 1 CLINICAL TRIAL; STATISTICAL MODEL; STATISTICS;

ANTINEOPLASTIC AGENT;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DOSAGE CALCULATIONS; HUMANS; MODELS, STATISTICAL; NEOPLASMS;

EID: 80455130105     PISSN: None     EISSN: 15574679     Source Type: Journal    
DOI: 10.2202/1557-4679.1298     Document Type: Article

References (29)

1. Azriel, D., M. Mandel, and Y. Rinott (2011): ́The treatment versus experimentation dilemma in dose finding studies,́ J. Statist. Plann. Inference, 141, 2759-2768.
2. Babb, J., A. Rogatko, and S. Zacks (1998): ́Cancer phase I clinical trials: Efficient dose escalation with overdose control,́ Stat. Med., 17, 1103-1120. (Pubitemid 28221028)
3. Chang, H.-H. and Z. Ying (2009): ́Nonlinear sequential designs for logistic item response theory models with applications to computerized adaptive tests,́ Ann. Stat., 37, 1466-1488.
4. Cheung, Y. (2002): ́Letter to the editor,́ Biometrics, 58, 237-240.
5. Cheung, Y. and R. Chappell (2002): ́A simple technique to evaluate model sensitivity in the continual reassessment method,́ Biometrics, 58, 671-674. (Pubitemid 35001486)
6. Derman, C. (1957): ́Non-parametric up-and-down experimentation, ́ Ann. Math. Statist., 28, 795-798.
7. Dixon, W. and A. Mood (1948): ́A method for obtaining and analyzing sensitivity data,́ J. Am. Statist. Assoc., 43, 109-126.
8. Durham, S. and N. Flournoy (1995): ́Up-and-down designs. I. Stationary treatment distributions,́ in Adaptive designs (South Hadley, MA, 1992), IMS Lecture Notes Monogr. Ser. volume 25, Hayward, CA: Inst. Math. Statist., 139-157.
9. Gezmu, M. (1996): The Geometric Up-and-Down Design for Allocating Dosage Levels, Ph.D. thesis, American University, Washington, DC, USA.
10. Gezmu, M. and N. Flournoy (2006): ́Group up-and-down designs for dosefinding,́ J. Statist. Plann. Inference, 136, 1749-1764.
11. Haines, L., I. Perevozskaya, and W. Rosenberger (2003): ́Bayesian optimal designs for phase I clinical trials,́ Biometrics, 59, 591-600. (Pubitemid 37093398)
12. Ivanova, A., N. Flournoy, and Y. Chung (2007): ́Cumulative cohort design for dose-finding,́ J. Statist. Plann. Inference, 137, 2316-2327.
13. Leung, D. H.-Y. and Y.-G.Wang (2001): ́Isotonic designs for phase I trials,́ Cont. Clin. Trials, 22, 126-138. (Pubitemid 32289449)
14. Lord, M. (1980): Applications of Item Response Theory to Practical Testing Problems., Erlbaum, Hillsdale, NJ.
15. Mathew, P. et al. (2004): ́Platelet-derived growth factor receptor inhibitor imatinib mesylate and docetaxel: A modular phase I trial in androgen-independent prostate cancer,́ J. Clin. Oncol., 22, 3323-3329. (Pubitemid 41103689)
16. O'Quigley, J., M. Pepe, and L. Fisher (1990): ́Continual reassessment method: a practical design for Phase I clinical trials in cancer,́ Biometrics, 46, 33-48. (Pubitemid 20245604)
17. O'Quigley, J. and S. Zohar (2006): ́Experimental designs for phase I and phase I/II dose-finding studies,́ Brit. J. Canc., 94, 609-613. (Pubitemid 43361888)
18. Oron, A. (2007): Up-and-Down and the Percentile-Finding Problem, Ph.D. thesis, University of Washington, Seattle, Washington, USA, available on http://arxiv.org/abs/0808.3004.
19. Oron, A. and P. Hoff (2009): ́The k-in-a-row up-and-down design, revisited,́ Stat. Med., 28, 1805-1820.
20. Paoletti, X., J. O'Quigley, and J. Maccario (2004): ́Design efficiency in dose finding studies,́ Comp. Stat. Dat. Anal., 45, 197-214. (Pubitemid 38204899)
21. Pisters, P.W. et al. (2004): ́Phase I trial of preoperative doxorubicin-based concurrent chemoradiation and surgical resection for localized extremity and body wall soft tissue sarcomas,́ J Clin Oncol, 22, 3375-3380. (Pubitemid 41103696)
22. R Development Core Team (2011): R: A language and environment for statistical computing, R Foundation for Statistical Computing, Vienna, Austria, ISBN 3- 900051-07-0.
23. Robertson, T., F. T. Wright, and R. L. Dykstra (1988): Order restricted statistical inference, Wiley Series in Probability and Mathematical Statistics: Probability and Mathematical Statistics, Chichester: John Wiley &Sons.
24. Roy, A., S. Ghosal, and W. Rosenberger (2009): ́Convergence properties of sequential Bayesian D-optimal designs,́ J. Statist. Plann. Inference, 139, 425-440.
25. Shen, L. Z. and J. O'Quigley (1996): ́Consistency of continual reassessment method under model misspecification,́ Biometrika, 83, 395-405.
26. Shirayev, A. (1996): Probability, Second Edition, New York: Springer, translated by R.P. Boas.
27. Watson, A. and D. Pelli (1979): ́The QUEST staircase procedure,́ Appl. Vis. News., 14, 6-7.
28. Yuan, Z. and R. Chappell (2004): ́Isotonic designs for phase I cancer clinical trials with multiple risk groups,́ Clin. Trials, 1, 499-508.
29. Zacks, S., A. Rogatko, and J. Babb (1998): ́Optimal bayesian-feasible dose escalation for cancer Phase I trials,́ Stat. Prob. Lett., 38, 215-220. (Pubitemid 128181982)