Sylvester R, Minder C E
EORTC Data Center, Brüssel, Belgien.
Urologe A. 1995 Sep;34(5):367-73.
A phase III clinical trial is a comparative study in which one assesses the relative efficacy of a treatment or treatments. It generally has one of the following objectives: 1. To determine the effectiveness of a new treatment relative to the natural history of the disease, for example when comparing a new treatment to not treatment or to placebo in an adjuvant setting. 2. To determine if a new treatment is more effective than the best current standard therapy (at the risk of increasing the toxicity). 3. To determine if a new treatment is as effective as the best current standard therapy but is associated with less severe toxicity or a better quality of life (equivalence trial). Clinical trials must be properly designed in order to answer such questions with a high degree of certainty. The purpose of this paper is to present several concepts which must be taken into account during the process of designing a clinical trial.
III期临床试验是一项对比研究，在该研究中评估一种或多种治疗方法的相对疗效。它通常有以下目标之一：1. 确定新治疗方法相对于疾病自然史的有效性，例如在辅助治疗环境中，将新治疗方法与不治疗或安慰剂进行比较时。2. 确定新治疗方法是否比当前最佳标准疗法更有效（存在增加毒性的风险）。3. 确定新治疗方法是否与当前最佳标准疗法同样有效，但毒性较轻或生活质量更好（等效性试验）。为了高度确定地回答此类问题，必须对临床试验进行合理设计。本文的目的是介绍在设计临床试验过程中必须考虑的几个概念。
