Zelen M
N Engl J Med. 1979 May 31;300(22):1242-5. doi: 10.1056/NEJM197905313002203.
This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients in the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline, they receive the best standard treatment. In the analyses of results, all those in the second group, regardless of treatment, are compared with those in the first group. Any loss of statistical efficiency can be overcome by increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage that, before providing consent, a patient will know whether an experimental treatment is to be used.
本文提出了一种规划随机临床试验的新方法。该方法特别适用于将最佳标准治疗或对照治疗与实验性治疗进行比较。患者通过随机或偶然机制被分为两组。第一组患者接受标准治疗；第二组患者被询问是否愿意接受实验性治疗；如果他们拒绝，他们将接受最佳标准治疗。在结果分析中，将第二组中的所有患者，无论接受何种治疗，与第一组中的患者进行比较。统计效率的任何损失都可以通过增加样本数量来克服。这种实验方案确实是一种随机临床试验，其优点是，在患者提供同意之前，他们将知道是否会使用实验性治疗。
