Cipriani Andrea, Girlanda Francesca, Barbui Corrado
Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Verona, Italy.
Epidemiol Psichiatr Soc. 2009 Oct-Dec;18(4):311-3. doi: 10.1017/s1121189x00000269.
One of the most important critical decision to be taken when designing a randomized controlled trial (RCT) in clinical psychopharmacology is the choice of the comparator. This choice is crucial because it affects many issues related to both internal and external validity. The aim of a RCT may be to establish efficacy in absolute terms, against an inert treatment (usually a placebo), or to establish efficacy with respect to another treatment (also known as comparator), a trial may be designed to demonstrate that the new drug is superior to the control intervention or, by contrast, that the new drug is similar to the control intervention in terms of, say, symptoms' reduction. Three kinds of RCTs may be designed: Superiority trials, Equivalence studies, Non-inferiority studies.
在临床精神药理学中设计随机对照试验（RCT）时，需要做出的最重要的关键决策之一是对照物的选择。这一选择至关重要，因为它会影响许多与内部效度和外部效度相关的问题。RCT的目的可能是相对于惰性治疗（通常是安慰剂）确定绝对疗效，或者相对于另一种治疗（也称为对照物）确定疗效，一项试验可能旨在证明新药优于对照干预，或者相反，证明新药在例如症状减轻方面与对照干预相似。可以设计三种类型的RCT：优效性试验、等效性研究、非劣效性研究。
