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http://dx.doi.org/10.7469/JKSQM.2011.39.2.329

Effect of the Erimental Design on the Determination of MTD in Phase I Clinical Trial  

Lee, Yoon-Dong (Department of Business Administration, Sogang University)
Lee, Eun-Kyung (Department of Statistics, Ewha Womans University)
Publication Information
Journal of Korean Society for Quality Management / v.39, no.2, 2011 , pp. 329-336 More about this Journal
Abstract
The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.
Keywords
Clinical Trial Design; Phase I Trial; Adaptive Design; TER;
Citations & Related Records
Times Cited By KSCI : 2  (Citation Analysis)
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