- Volume 18 Issue 2
The purpose of a Phase I clinical trial is to estimate the maximum tolerated dose, MTD, of a new drug. In this paper, the MTD estimation method is suggested by curve fitting the dose-toxicity data to an S-shaped curve. The suggested MTD estimation method is compared with established MTD estimation procedures using a Monte Carlo simulation study.
Phase I clinical trial;Maximum tolerated dose(MTD);dose-toxicity curve
- 강승호 (2002). 1상 임상실험에서 수정된 CRM에 대한 연구, <응용통계연구>, 15, 323–336. https://doi.org/10.5351/KJAS.2002.15.2.323
- 김동욱, 길순경 (2009). 제 1상 임상시험의 SM, CRM, ATD에서 결정된 MTD의 정확성과 안전성비교, <한국통계학회 논문집>, 16, 51–65. https://doi.org/10.5351/CKSS.2009.16.1.051
- 박인혜 (1999). <제 1상 축차 임상시험의 최대 허용용량 추정법>, 가톨릭대학교 의학통계학과 의학통계전공 석사논문.
- Chevret, S. (1993). The continual reassessment method in cancer phase I clinical trials: A simulation study, Statistics in Medicine, 12, 1093–1108.
- 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.
- Faries, D. (1994). Practical modifications of the continual reassessment method for phase I cancer clinical trials, Journal of Biopharmaceutical Statistics, 4, 147–164. https://doi.org/10.1080/10543409408835079
- 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. https://doi.org/10.1002/sim.4780141102
- Johns, H. and Joiner, M. C. (1991). A simple method for fitting curves to dose-effect data for functional damage, International Journal of Radiation Biology, 60, 533–541.
- 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. https://doi.org/10.1002/sim.4780131802
- 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, 1647-16641093-1108. https://doi.org/10.1002/sim.4780101104
- Storer, B. E. (1989). Design and analysis of phase I clinical trials, Biometrics, 45, 925–937. https://doi.org/10.2307/2531693