Grossman Jason, Mackenzie Fiona J
Unit for History and Philosophy of Science, University of Sydney, NSW, Australia.
Perspect Biol Med. 2005 Autumn;48(4):516-34. doi: 10.1353/pbm.2005.0092.
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.
随机对照试验（RCT）并非金标准：它在某些情况下是一种不错的实验设计，但仅此而已。随机对照试验在设计和实施方面的潜在缺点常常被顺带提及，然而大多数研究人员认为随机对照试验总是优于所有其他类型的证据。本文审视了随机对照试验的局限性，并表明一些通常被认为不如所有随机对照试验的证据类型实际上优于许多随机对照试验。这对研究方法、临床医学中的医疗质量，尤其是对研究资助政策都有重要影响。由于每种研究设计在特定应用中都可能存在问题，因此应该依据适当的标准对研究进行评估，而不是主要依据循证医学运动的一些杰出倡导者所推崇的简单的随机对照试验/非随机对照试验二分法以及基于其原则的研究评估指南。
