Pressure to Publish: A Campaign For Access to Trial Data
A public campaign, AllTrials, has been launched to influence governments, regulators and research bodies to ensure that all clinical trials, past and present, are registered and their full methods and results published.
When half of all clinical trials never get published, and are not even registered, the concern over the quality of evidence used in making decisions about the course of treatment or research, or both, is a pressing one. AllTrials comes to live following an announcement made by the House of Commons Science and Technology committee at the end of last year about an inquiry into missing trial data.
The action was triggered by, among other things, Ben Goldacre's 'Bad Pharma', a book addressing the issue of what doctors don't know about the medicines they're prescribing, in which he described the way in which big pharma pick and choose which trial results they make available, creating a biased picture of the effectiveness of new drugs. The call for change is accompanied by a petition at AllTrials.net which has so far attracted six and a half thousand signiatures.
Around the same time, other MPs have asked the Commons Public Accounts Committee to investigate the waste of NHS resources, saying that the government should demand that the £500m (€620m; $810m) it spent in 2009 on stockpiling oseltamivir be given back if it was found that the manufacturer withheld trial data showing it to be no more effective than placebo. This decision followed from a campaign launched by the 'British Medical Journal' for Roche to release full reports on oseltamivir (Tamiflu) to independent assessors.
“Everybody agrees that clinical trials should be registered and that we should at the very least have clinical reports on what was found. […] We expect regulatory bodies to evaluate the best available evidence, not half of it. The missing results from the last 20 years also represent lost opportunities to learn from all that research and to develop some of it in light of new discoveries,” Tracy Brown, director of Sense About Science, one of the backers of the initiative, wrote on AllTrials.net.
The campaigners stress the role of the European Medicines Agency in making a change. While the new European Union Regulation on Clinical Trials, that will replace existing Clinical Trials Directive, aims to make all the trial application information, results and data publicly accessible, unless there are confidentiality concerns that justify protection of personal data or commercial information that should not be disclosed, it fails to name sanctions that study sponsors will face for violating those requirements. Responding to that, an editorial published in the 'BMJ' urged patients and healthy volunteers to refuse participating in a trial that does not guarantee publication. '[T]he interests of public health and the citizens’ right to know should override any invocation of commercial confidentiality. Patients volunteer for research to benefit society and future patients, not to benefit a particular drug company.' Peter Gøtzsche, from the Nordic Cochrane Center,wrote in the 'BMJ'.
The present campaign is supported by David Tovey, of The Cochrane Library, Ben Goldacre, author of 'Bad Pharma', Richard Stephens, the Chair of the NIHR Cancer Consumer Liaison Group, Carl Heneghan, the Director of the Centre for Evidence-Based Medicine at the University of Oxord, and Sir Iain Chalmers, from the James Lind Initiative, as well as racy Brown, director of Sense About Science.