• 응용통계연구
• /
• 제33권2호
• /
• pp.137-145
• /
• 2020

'투약용량 발견 시험(Dose Finding Study)'라고도 불리는 제 1상 임상시험은 동물 실험 혹은 시험관 실험을 통하여 개발된 신약물질을 사람에게 실시하는 첫 단계이다. 제1상 임상시험의 가장 주요한 목적은 환자에게 허용할 수 있고 최대의 효능을 가진 복용량을 결정하는 것이다. 본 논문에서는 이를 고려하여 최대허용용량(MTD)를 결정할 수 있는 적절한 추정방법을 제안하였다. 이 방법은 Biased coin design과 멈춤규칙을 이용하여 MTD를 추정한다. 제안하는 방법은 모의실험을 통해 기존의 방법들과 비교하였다.

• Communications for Statistical Applications and Methods
• /
• 제19권6호
• /
• pp.877-884
• /
• 2012

Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

• Journal of the Korean Statistical Society
• /
• 제14권1호
• /
• pp.48-55
• /
• 1985

In clinical trials subjects are avalible sequentially and must be assigned to treatments immediately. Completely randomized procedure for the allocation of treatments to each subject may result in severe imbalance among the number of subjects in treatment groups, especially for small experiments or interim analyses of large experiments. In this study, restricted randomization methods such as biased coin designs (Efron, 1971), permuted block design, and truncated binomial design are compared to teh completely randomized design in the presence of selection and/or accidential bias by Monte Carlo simulations.