Communications for Statistical Applications and Methods

The Korean Statistical Society (한국통계학회)
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Two-Stage Maximum Tolerated Dose Estimation by Stopping Rule in a Phase I Clinical Trial

제1상 임상시험에서 Stopping Rule을 이용한 두 단계 MTD 추정법

  • Lee, Na-Mi (Department of Biostatistics, The Catholic University of Korea) ;
  • Kim, Dong-Jae (Department of Biostatistics, The Catholic University of Korea)
  • 이나미 (가톨릭대학교 의학통계학과) ;
  • 김동재 (가톨릭대학교 의학통계학과)
  • Received : 20111000
  • Accepted : 20111100
  • Published : 2012.01.30
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Abstract

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.

제 1상 임상시험에서 주목표는 부작용이 발생하지 않고 피험자가 견딜 수 있는 한도 내에서 최대 용량인 최대허용용량(Maximum Tolerated Dose; MTD)을 결정하는 것이다. 최대허용용량을 결정하는 방법에는 SM방법, CRM방법 등이 있는데 본 논문에서는 기존의 Stopping rule을 변형한 두 단계 MTD 추정방법을 제안하였다. 기존의 방법들을 본 논문에서 제안한 방법과 모의실험을 통하여 비교하였다.

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References

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  1. Maximum Tolerated Dose Estimation with Dose De-Escalation Design in a Phase I Clinical Trials vol.27, pp.7, 2014, https://doi.org/10.5351/KJAS.2014.27.7.1115
  2. Adjusted maximum tolerated dose estimation by stopping rule in phaseⅠclinical trial vol.23, pp.6, 2012, https://doi.org/10.7465/jkdi.2012.23.6.1085