Torgerson D J, Ryan M, Ratcliffe J
National Primary Care Research and Development Centre, University of York.
QJM. 1995 Jul;88(7):517-21.
In the design of clinical trials, sample size determination is usually undertaken by statisticians and clinicians. It is rare for health economists to be involved in this aspect of trial design. However, there are a number of outcome changes that are of 'economic significance', and it is important for trial designers and funders to be aware of these before planning, funding and mounting a trial. In this paper we demonstrate through the use of three examples (prevention of osteoporosis, management of infertility, and endometriosis) how economics can be used to influence the size of a clinical trial. Trials that are too small or too large waste research resources; health economics can lead to more efficient trial designs.
在临床试验设计中，样本量的确定通常由统计学家和临床医生负责。健康经济学家很少参与试验设计的这一方面。然而，有一些结局变化具有“经济意义”，对于试验设计者和资助者而言，在规划、资助和开展一项试验之前了解这些变化很重要。在本文中，我们通过三个例子（骨质疏松症的预防、不孕症的管理和子宫内膜异位症）展示了如何利用经济学来影响临床试验的规模。规模过小或过大的试验都会浪费研究资源；健康经济学可以带来更有效的试验设计。
