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http://dx.doi.org/10.5351/KJAS.2014.27.7.1115

Maximum Tolerated Dose Estimation with Dose De-Escalation Design in a Phase I Clinical Trials  

Jang, Eunah (Department of Biomedicine.Health Science, The Catholic University of Korea)
Kim, Dongjae (Department of Biomedicine.Health Science, The Catholic University of Korea)
Publication Information
The Korean Journal of Applied Statistics / v.27, no.7, 2014 , pp. 1115-1123 More about this Journal
Abstract
The main purpose of phase I clinical trials is to estimate the Maximum Tolerated Dose (MTD), which minimizes side effect and assures safety of a new drug by evaluating the toxicity at each dose-level. The conventional MTD estimation methods is Standard method (Storer, 1989; Korn et al., 1994), Accelerated Titration Designs (Simon et al., 1997) and DM method (Dixon and Mood, 1948) etc. In this paper, MTD estimation method with de-escalation is suggested phase I clinical trials. The proposed MTD estimation method is compared to Accelerated Titration Designs, SM3 without de-escalation method and SM3 with de-escalation method using a Monte Carlo simulation.
Keywords
Phase I clinical trials; MTD (maximum tolerated dose); de-escalation;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
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1 Storer, B. E. (1989). Design and analysis of phase I clinical trials, Biometrics, 45, 925-937.   DOI   ScienceOn
2 Chevret, S. (1993). The continual reassessment method in cancer phase I clinical trials, A simulation study, Statistics in Medicine, 12, 1093-1108.   DOI   ScienceOn
3 Dixon, W. J. and Mood, A. M. (1948). A method for obtaining and analyzing sensitivity data, Journal of the American Statistical Association, 43, 109-126.   DOI   ScienceOn
4 Goodman, S. N., Zhurak, M. L. and Piantadosi, S. (1995). Some practical improvements in the continualreassessment method for phase I studies, Statistics in Medicine, 14, 1149-1161.   DOI   ScienceOn
5 Korn, E. L., Midthune, D., Chen, T. T., Rubinstein, L. V., Christian, M. C. and Simon, R. M. (1994). Acomparison of two phase I trial designs, Statistics in Medicine, 13, 1799-1806.   DOI   ScienceOn
6 Lee, N. M. and Kim, D. (2012). Two-stage maximum tolerated dose estimation by stopping rule in phase I clinical trials, Journal of the Korean Statistical Society, 19, 57-64.   DOI
7 O'Quigley, J. and Chevret, S. (1991). Method for dose finding studies in cancer clinical trials: A review and results of a Monte Carlo study, Statistics in Medicine, 10, 1647-1664.   DOI   ScienceOn
8 Simon, R., Freidlin, B., Rubinstein, L., Arbuck, S.G. and Collins, J. (1997). Accelerated Titration Designs for Phase I Clinical Trials in Oncology, Journal of the National Cancer Institute, 89, 1138-1147.   DOI   ScienceOn