Chairman of UK's NICE slams traditional ways of assessing therapeutic interventions

Sir Michael Rawlins, Chairman of the UK's National Institute for Health and Clinical Excellence (NICE), which advises on treatments under the National Health Service (excluding Scotland), argues that a new approach to analysing clinical evidence is needed. He calls for simpler and cheaper drug trials to be used to make new medicines available to patients.

The evidence discussed in Sir Michael's Harveian Oration delivered at the Royal College of Physicians, London, has only one purpose: it is the basis for informing decisions about the appropriate use of therapeutic interventions (including pharmaceuticals, devices and surgical procedures) in routine medical practice, he said. Such decisions have to be made at various levels, but with critical consequences for patients, their families and society. They include the decisions that physicians make for individual patients, as well as assessing whether interventions are safe, effective and cost effective for health care systems as a whole. Mistakes can have repercussions at all levels, he warned.

Randomized controlled trials (RCTs), long regarded as the "gold standard" of evidence, have been put on an undeserved pedestal. Their appearance at the top of "hierarchies" of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence-base, he stated.