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http://dx.doi.org/10.5351/KJAS.2020.33.2.137

Maximum tolerated dose estimation by Biased coin design and stopping rule in Phase I clinical trial  

Jeon, Soyoung (Department of Biomedicine.Health Science, The Catholic University of Korea)
Kim, Dongjae (Department of Biomedicine.Health Science, The Catholic University of Korea)
Publication Information
The Korean Journal of Applied Statistics / v.33, no.2, 2020 , pp. 137-145 More about this Journal
Abstract
Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.
Keywords
Phase I clinical trials; maximum tolerated dose; Biased coin design; stopping rule;
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