第一期臨床試驗的目的是針對新的藥物評估人體可以容忍其最大毒性的劑量，也就是最大耐受劑量。癌症藥物的毒性因為比一般藥物強，所以在癌症藥物第一期臨床試驗中會特別探討受測病人毒性反應的情形，基於保護病人的道德立場上，期望在試驗中的受測者人數可以達到最小。3+3試驗(Storer,1989)是癌症藥物第一期臨床試驗中常會使用到的臨床試驗，其試驗中各步驟下的藥物劑量水準是必須在試驗之前就決定好的。目前文獻中所提及的還有以3+3試驗為準則所衍生出來的5+3試驗(Gordon et al., 2001)、2+4試驗(Lee et al., 2009)、3+3+3試驗(Lee et al., 2009)以及3+1+1試驗(Storer, 2001)，但都未曾針對這些試驗間進行比較。在本論文中考慮符合現實中的試驗情形，以模擬的方式進行3+3試驗與其類似試驗間的探討與比較。

The main purpose of the phase I clinical trial is to assess the highest possible but still tolerable dose of a new drug with respect to some prespecified dose-limiting toxicity, which is also defined as maximum tolerated dose (MTD). The anti-cancer drugs are cytotoxic agents which are more toxic than the usually pharmaceutical agents for treatment of other diseases. Therefore, the guiding principle for dose escalation in phase I cancer clinical trial is to minimize exposure of subjects to the intervention. A traditional 3+3 design (Storer, 1989) is usually conducted in phase I cancer clinical trial to find the MTD. It is easy to conduct by the investigators and the testing dose levels are prespecified. There are some modified designs based on the 3+3 design, such as the 5+3 design (Gordon et al., 2001), the 2+4 design (Lee et al., 2009), the 3+3+3 design (Lee et al., 2009) and 3+1+1 design (Storer, 2001). In this research, we will discuss and compare the properties that the investigators might be interested based on the simulation study.

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