统计问题第26问:交叉设计临床研究,你懂多少?

交叉临床试验通过在个人间比较两种治疗,避免了年龄、性别等因素的影响。无需对照组,减少了样本需求。但若疾病随时间变化,效果解读复杂。

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Question

‍Which of the following statements apply to cross-over clinical trials?

· a) They are not subject to confounding by age, sex, or most personal characteristics

· b) Randomisation is not possible

· c) They are useful in studies using mortality as the endpoint

· d) They need fewer people than parallel group trials

Answer

In a crossover trial each person receives the two treatments to be compared: first one, then the other. The order in which the treatments are given can be randomised and it is good practice to avoid a systematic advantage to one treatment and to improve the prospects of preserving blinding when this is part of the design.

If the disease being studied is a stable long term condition then this approach has several advantages. Because the effect is compared within each person, the usual problems of confounding caused by differences between people who receive one treatment or the other do not exist. The comparison within each person also reduces variability and a control group is not needed, so fewer people are needed for the study. However, if the condition changes over time, or if the effect of one treatment persists into the time the other treatment is given, then the results can be difficult to disentangle.‍

所以答案是选择 AD

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