The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
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Maximum Tolerated Dose Estimation by Stopping Rule and SM3 Design in a Phase I Clinical Trial

제 1상 임상시험에서 멈춤 규칙과 SM3 디자인을 이용한 최대허용용량 추정법

  • Kim, Byoungchan (Department of Biostatistics, The Catholic University of Korea) ;
  • Kim, Dongjae (Department of Biostatistics, The Catholic University of Korea)
  • 김병찬 (가톨릭대학교 의학통계학과) ;
  • 김동재 (가톨릭대학교 의학통계학과)
  • Received : 2013.10.15
  • Accepted : 2013.11.15
  • Published : 2014.02.28
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Abstract

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

제 1상 임상시험의 목적은 피험자가 견딜 수 있는 최대의 용량인 최대허용용량(Maimum Tolerated Dose; MTD)을 추정하는 것이다. 최대허용용량을 추정하는 방법으로는 SM방법, ATD방법, CRM방법 등이 있다. 본 연구에서는 제 1상 임상시험에서 멈춤규칙을 이용한 최대허용용량 추정법을 제안하였다. 제안한 최대허용용량 추정법은 연속재평가방법(Continual Reassessment Method; CRM)과 모의실험을 통해 비교하였다.

Keywords

References

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