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Precision and Safety Comparison for SM, CRM and ATD in Phase I Clinical Trials
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 Title & Authors
Precision and Safety Comparison for SM, CRM and ATD in Phase I Clinical Trials
Kim, Dong-Uk; Kil, Sun-Kyoung;
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The purpose of a phase I clinical trial is to determine the maximum tolerated dose(MTD) of a new drug. This paper investigates the performance of standard method, continual reassessment method and accelerated titration designs in phase I clinical trials. Especially we study the precision and safety at the MTD of these methods. We utilize hyperbolic tangent function and power function to define dose-toxicity model. For each method, expected toxicity rate at MTD is computed and compared with target toxicity probability. We also suggest some modifications of these methods and show some improvements in performance.
Maximum tolerated dose;expected toxicity rate;phase I clinical trials;SM;CRM;ATD;safety;precision;dose-toxicity model;
 Cited by
약물독성시험에서 실험설계가 MTD의 결정에 미치는 영향,이윤동;이은경;

품질경영학회지, 2011. vol.39. 2, pp.329-336
제1상 임상시험에서 곡선적합을 이용한 MTD 추정법,허은하;김동재;

Communications for Statistical Applications and Methods, 2011. vol.18. 2, pp.179-187 crossref(new window)
제 1상 임상시험에서 멈춤 규칙과 SM3 디자인을 이용한 최대허용용량 추정법,김병찬;김동재;

응용통계연구, 2014. vol.27. 1, pp.13-20 crossref(new window)
Maximum Tolerated Dose Estimate by Curve Fitting in Phase I Clinical Trial, Communications for Statistical Applications and Methods, 2011, 18, 2, 179  crossref(new windwow)
Maximum Tolerated Dose Estimation by Stopping Rule and SM3 Design in a Phase I Clinical Trial, Korean Journal of Applied Statistics, 2014, 27, 1, 13  crossref(new windwow)
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Kang, S. H. (2003). Consistency and asymptotic normality of a modified likelihood approach continual reassessment method, Journal of the Korean Statistical Society, 32, 33-46

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O'Quigley. J. and Shen, L. Z. (1996). Continual reassessment method: A likelihood approach, Biometrics, 52, 673-684 crossref(new window)

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 crossref(new window)

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