ABSTRACT

The randomized controlled trial (RCT) has, in some ways, become the talisman for the EBM movement and is regarded, by many, as the gold standard trial for evaluating therapeutic interventions. The RCT came into being as it became obvious (to Pierre Louis and others in 19th century Paris) that observation of, and anecdotal reporting of, the results of therapeutic trials was inherently flawed. The fundamental problems of these ‘trials’ were the lack of a control group and the almost inevitability of bias.