Day S J
Respiratory Unit, Hospital for Sick Children, London, U.K.
Stat Med. 1988 Nov;7(11):1187-94. doi: 10.1002/sim.4780071112.
This paper considers the problem of comparing proportions in clinical trials where two parallel groups are studied. The question of what will happen to the response rate of an active therapy if some external factor affects the placebo rate is asked and two different, but similar, answers are proposed. Assuming either a logistic or probit model has substantial influence on the sample size required to detect differences and optimal comparisons are suggested. The idea is illustrated by a clinical trial of treatment for peptic ulcer and suggestions for other possible applications are presented.
本文探讨了在研究两个平行组的临床试验中比较比例的问题。提出了如果某个外部因素影响安慰剂率，活性疗法的反应率会发生什么变化的问题，并给出了两个不同但相似的答案。假设逻辑模型或概率模型对检测差异所需的样本量有重大影响，并提出了最优比较方法。通过一项消化性溃疡治疗的临床试验来说明这一理念，并给出了其他可能应用的建议。
