Thursday, 14 January 2010

NICE Chair criticises RCTs

Sir Michael Rawlins has been chairman of the National Institute for Health and Clinical Excellence (NICE) since its inception in 1999. He has attacked traditional ways of assessing medical evidence, particularly for pharmaceutical drugs.$1245035$365674.htm

In particular, he is critical of Randomised Controlled Test (RCT's), for so long the main totem for homeopathy denialists, and the chief means of testing pharmaceutical drugs. Sir Michael outlines the limitations of RCTs in several key areas:

# Impossible - for treatments for very rare diseases where the number of patients is too limited.

# Unnecessary - when a treatment produces a "dramatic" benefit - imatinib (Glivec) for chronic myeloid leukaemia.

# Stopping trials early - interim analyses of trials are now commonly undertaken to assess whether the treatment is showing benefit and if the trial can be stopped early. Around 30% of recent trials in oncology have been stopped early for apparent benefit. Although the desire to stop trials early is understandable, the possibility that an interim analysis is a "random high" may be difficult to avoid - especially as there is no consensus among statisticians as to how best to handle this problem.

# Resources - the costs of RCTs are substantial in money, time and energy - a recent study of 153 trials completed in 2005 and 2006 showed a median cost of over £3 million and with one trial costing £95 million. One manufacturer has estimated that the average cost per patient increased from £6,300 in 2005 to £9,900 in 2007

# Generalisability - RCTs are often carried out on specific types of patients for a relatively short period of time, whereas in clinical practice the treatment will be used on a much greater variety of patients - often suffering from other medical conditions - and for much longer. There is a presumption that, in general, the benefits shown in an RCT can be extrapolated to a wide population; but there is abundant evidence to show that the harmfulness of an intervention is often missed in RCTs.

Far better, perhaps, to rely on a medical therapy like homeoopathy, with its long history of effective treatment, and safety.