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新药物的临床试验可分为四期,各有其特定目的。Ⅰ期研究是描述其临床毒理学,和建立药剂的最佳进药方式,Ⅱ期研究是测定其比活,Ⅲ期研究是与已知药物比较测定其效价,Ⅳ期研究是设计此药与其他药物的配伍方案。但Ⅰ、Ⅱ期研究间并无明显界限,虽然Ⅰ期研究并不是为新药物的抗肿瘤活性而设计,但临床工作者不会不注意到该药物是否确实具有这些活性。同样,在Ⅱ期研究中也可检测到Ⅰ期试验所未观察到的一些毒性。
Clinical trials of new drugs can be divided into four phases, each with its own specific purpose. The phase I study describes the clinical toxicology and the best way to establish the drug, the phase II study determines the specific activity, the phase III study compares potency with known drugs, and the phase IV study is designed for this drug Compatibility with other drugs programs. However, there is no clear boundary between Ⅰ and Ⅱ studies. Although Phase Ⅰ research is not designed for the antitumor activity of new drugs, clinicians will not fail to notice whether these drugs actually possess these activities. Similarly, some of the toxicities observed in phase I trials were also detectable in Phase II studies.