新藥物在核准上市前都必須經過四個階段的臨床試驗，其中第一階段臨床試驗是首次將新藥物作用於人體上的一個階段。第一階段臨床試驗的主要研究目的是要瞭解新藥物的安全劑量範圍，也就是訂定最大耐受劑量，作為第二階段臨床試驗的建議劑量。過去的文獻都只針對單一層面作探討，如:估計的準確性、總試驗人數或中毒人數等，並未針對整體作有效的評估。本文將針對傳統3+3設計與連續性評估設計作出修正，將兩個方法結合，提出一個新的估計最大耐受劑量的方法，並針對模擬結果，建立一個量化的評估指標，以有效地評估何種方法在估計最大耐受劑量的問題上，最為恰當。

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.

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