Randomised controlled trials

In December 2005, Professor (now Sir) Ian Wilmut, the first director of Edinburgh University's Centre for Regenerative Medicine, called for stem cell treatments to be offered to people with terminal illnesses. He argued that the benefits of offering such treatments before they had been properly evaluated might outweigh the risks, saying, ‘if we wait until things are totally tested and analysed in animals, it will deny some people treatment’ (BBC News, 2005).

This ran counter to the prevailing medical culture of evidence-based medicine (EBM), one definition of which is ‘…the conscientious explicit and judicious use of current best evidence in making decisions about the care of individual patients' (Sackett et al, 1996). EBM has not been universally lauded by the medical profession. For example, the not altogether tongue-in-cheek Clinicians for the Restoration of Autonomous Practice (CRAP) Writing Group (2002) derided the reverence extended towards the randomised controlled trial (RCT) as a pillar of EBM.