MEDICAL RESEARCH COUNCIL CENTENARY 1913-2013
Make all research results public
by Sir Iain Chalmers on April 4, 2013

… clinical trials… are impossible unless patients agree to participate in them… All participants in clinical trials believe that their involvement will help to increase knowledge about the effects of treatments. They expect that people with health problems like theirs – and perhaps they themselves – will be able to make better informed treatment decisions in future as a result of their contributions to knowledge.

How come, then, that the research community, including research funders and regulators, have acquiesced for decades in the non-publication of around 50 per cent of all clinical trials? Can this be characterised as anything other than a gross betrayal of the trust in researchers which motivated volunteers to participate in clinical trials in the first place? How many of them would have agreed to participate if researchers had told them “If the results of this trial don’t serve our academic or commercial interests we won’t make them public”?

After doing research on biased under-reporting of research 20 years ago, I raised these issues in an article published in the Journal of the American Medical Association entitled ‘Underreporting research is scientific misconduct’. The evidence that has accumulated over the subsequent two decades has made clear that the problem is widespread. It’s not only unethical and scientific misconduct; it is also simply a waste of precious research resources. As illustrated by numerous examples, under-reporting of research has led to harm to patients from exaggerated estimates of treatment benefits and safety, and built-in inefficiency in efforts to discover useful and safer treatments…

So what has happened to change the terms of the debate after a quarter of a century during which researchers, research funders, research regulators and politicians have failed to address the problem seriously? Two things. First, Dr Ben Goldacre published Bad Pharma — a book making clear to the public, using a mountain of evidence, why they should be concerned about the situation. In brief, his message is: ‘How can you or your doctor make an informed choice about which treatment to choose if half the relevant evidence has not been made public?’

Second, Sense about Science, an organisation campaigning to promote science to the public, has decided that non-publication of clinical trials is a stain on the public image of science, and that, after years of wavering and disingenuous excuses for inaction, it must be confronted and dealt with… Sense about Science’s new campaign — All trials registered, all trials reported — aims to achieve just what its title calls for…

This article was originally published in the Spring 2013 issue of Network.

http://www.insight.mrc.ac.uk/2013/04...lic/#more-1955