An Evaluation of Estimating Methods for the Maximum Tolerated Dose (MTD) in Phase I Clinical Trial

• Main Authors: Yi-LiChen, 陳宜莉
• Other Authors: Mi-Chia Ma
• Format: Others
• Language: en_US
• Published: 2014
• Online Access: http://ndltd.ncl.edu.tw/handle/37156110748754497058

碩士 === 國立成功大學 === 統計學系 === 102 === Phase I clinical trials are the first application to humans in the clinical development of new drug agents. The main purpose of the phase I clinical trials is to understand the dose range of new drugs, that is to identify the Maximum Tolerated Dose (MTD) and to be recommended in phase II clinical trials. In this thesis, we introduce the Standard 3+3 design and the Continual Reassessment Method (CRM). CRM is the first model-based design for phase I oncology trial. And then we improved these two methods and proposed the combined methods to estimate MTD. Hence the proposed methods improve the shortcomings of the 3+3 design. There are a lot of evaluating methods in the literatures, but only for a single aspect, for example, the most common aspect is to evaluate the accuracy of estimating MTD. Therefore we can’t decide which method is superior. So the purpose of this paper is to establish a comprehensive evaluation criteria, not only consider accuracy but also assess the safety and ethical issues. Hence, we establish an evaluation index and conduct a simulation to effectively assess which method in estimating MTD is most appropriate.