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Estimation of Maximal Tolerated Dose in Sequential Phase I Clinical Trials
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  • Estimation of Maximal Tolerated Dose in Sequential Phase I Clinical Trials
  • Estimation of Maximal Tolerated Dose in Sequential Phase I Clinical Trials
저자명
Park. In-Hye,Song. Hae-Hiang
간행물명
한국통계학회 논문집
권/호정보
1999년|6권 2호|pp.543-564 (22 pages)
발행정보
한국통계학회
파일정보
정기간행물|ENG|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The principal aim of a sequential phase I clinical trial in which the toxicity reponses of a group of patient(s) determine the dose level of the next patient(s) group is to estimate the maximal tolerated dose(MTD) of a new drug, In this paper we compared with a simulation study the performance of the MTD estimates that are determined by a stopping rule in a design and also those that are determined by analyzing the data after a clinical trial is terminated. To the latter belong the mean median mode and maximum likelihood estimates. For the Standard Methods the stopping rule MTD is quite inefficient but the median MTD has a best efficiency and is robust with respect to the three different toxicity curves. The problem of non-convergence of MLE MTD is severe. A more improved MTD estimate is produced by combining the advantages of the various MTD estimates and its efficiency is better than the single median MTD estimate especially for the toxicity curve of an unlucky choice of dose levels. The simulation results suggest that simple types of phase I designs can be combined with relatively standard analytic techniques to provide a more efficient MTD estimate.