The randomized controlled trial: gold standard, or merely standard?

Abstract

The randomized controlled trial (RCT) is not a gold standard: it is a good experimental design in some circumstances, but that's all. Potential shortcomings in the design and implementation of RCTs are often mentioned in passing, yet most researchers consider that RCTs are always superior to all other types of evidence. This paper examines the limitations of RCTs and shows that some types of evidence commonly supposed to be inferior to all RCTs are actually superior to many. This has important consequences for research methodology, for quality of care in clinical medicine, and--especially--for research funding policy. Because every study design may have problems in particular applications, studies should be evaluated by appropriate criteria, and not primarily according to the simplistic RCT/non-RCT dichotomy promoted by some prominent advocates of the evidence-based medicine movement and by the research evaluation guidelines based on its principles.