Two-Stage Maximum Tolerated Dose Estimation by Stopping Rule in a Phase I Clinical Trial Lee, Na-Mi; Kim, Dong-Jae;
Phase I clinical trials determine the maximum tolerated dose(MTD) of a new drug. In this paper, we proposed a two-stage MTD estimation method by a Stopping rule in a phase I clinical trial. The suggested MTD estimation method is compared to the standard design(SM3) and the continual reassessment method(CRM) using a Monte Carlo simulation study.
Phase I clinical trial;maximum tolerated dose(MTD);Stopping rule;
Adjusted maximum tolerated dose estimation by stopping rule in phaseⅠclinical trial, Journal of the Korean Data and Information Science Society, 2012, 23, 6, 1085
Maximum Tolerated Dose Estimation with Dose De-Escalation Design in a Phase I Clinical Trials, Korean Journal of Applied Statistics, 2014, 27, 7, 1115
강승호(2002). 1상 임상실험에서 수정된 CRM에 대한 연구, <응용통계연구>, 15, 323-336.
김동욱, 길순경 (2009). 제 1상임상시험의 SM, CRM, ATD에서 결정된 MTD의 정확성과 안전성비교, <한국통계학회논문집>, 16, 51-65.
박인혜 (1999). 제 1상 축차 임상시험의 최대 허용용량 추정법, 가톨릭대학교 의학통계학과 의학통계 전공 석사논문.
Ahn, C. (1998). An evaluation of phase I cancer clinical trial designs, Statistics in Medicine, 17, 1537-1549.
Chevret, S. (1993). The continual reassessment method in cancer phaseⅠclinical trials: A simulation study, Statistics in Medicine, 12, 10930-1108.
Dixon, W. J. and Mode, A. M. (1948). A method for obtaining and analyzing sensitivity data, Journal of the American Statistical Association, 43, 109-126.
Goodman, S. N., Zhurak, M. L. and Piantadosi, S. (1995). Some practical improvements in the continual reassessment method for phase I studies, Statistics in Medicine, 14, 1149-1161.
Korn, E. L., Midthune, D., Chen, T. T., Rubinstein, L. V., Christian, M. C. and Simon, R. M. (1994). A comparison of two phase I trial designs, Statistics in Medicine, 13, 1799-1806.
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.
O'Quigley, J., Pepe, M. and Fisher, M. (1990). Continual reassessment method: A practical design for phase I clinical trials in cancer, Biometrics, 46, 33-48.
O'Quigley, J. and Shen, L. Z. (1996). Continual reassessment method: A likelihood approach, Biometrics, 52, 163-174.
Simon, R., Freidlin, B., Rubinstein, L., Arbuck, S. G., Collins, J. and Christian, M. C. (1997). Accelerated titration designs for phase I clinical trials in oncology, Journal of the National Cancer Institute, 89, 1138-1147.
Storer, B. E. (1989). Design and analysis of phase I clinical trials, Biometrics, 45, 925-937.