The best available evidence suggests that between a third and a half of all clinical trials conducted have not gone on to be published. Worse than that, trials with positive results are about twice as likely to be published as those with negative results. This means that when systematic reviews are conducted, analyzing all the available evidence on a particular topic, they often draw conclusions which do not reflect reality. So researchers, regulators, and doctors see a distorted picture and can’t make truly informed decisions about what treatments are best for patients.
That’s what led to the AllTrials campaign in January 2013, co-founded by Ben Goldacre, British Medical Journal, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS (Public Library of Science), and Sense About Science. The campaign is being led by Dartmouth's Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice in the United States.
AllTrials is calling for:
- All clinical trials to be registered before they start (and any previously conducted to be retrospectively registered) - this is so we know that the trial has happened at all.
- Summary results of trials to be made available within one year of the trial’s completion.
- Access to the Clinical Study Reports (where they have been produced), which provide the richest information on the methods and results used in a trial.
Sixty-thousand individuals and over 400 organizations have joined the campaign, including medical royal colleges, professional bodies (the British Medical Association, National Physicians Alliance), regulators like NICE (National Institute for Health and Care Excellence), funders (Medical Research Council and Wellcome), international organizations (World Association of Medical Editors), publishers (Wiley and SAGE) and 150 patient groups representing half a billion patients worldwide. A number of pharmaceutical companies (including Roche and LEO Pharma) have committed to sharing trial data, and GSK has signed up as a supporter of the campaign, with others discussing joining them.
The campaign is now nearly one year old and some good progress has been made in Europe and the UK. Thanks to our European supporters, who wrote to their MEPs and health ministers, important amendments to Clinical Trials Regulation were voted for by the European Parliament earlier this year. Discussions on the Regulation are currently taking place, with a decision expected by the end of the year. If these amendments are adopted, it will mean that all clinical trials conducted in Europe would have to be registered and summary results reported within a year of the trial’s end. In the UK, the Health Research Authority has implemented a plan to ensure UK clinical trials are registered in a publicly accessible database. Since the September 30, 2013 trial registration within six weeks of the first patient being recruited became a condition of ethics approval in the UK. In November 2013, the UK Government responded to the Science and Technology Committee’s inquiry into clinical trials with some positive comments, including supporting the European amendments currently in discussion, prospective trial registration, publication of summary results, and Clinical Study Reports where available. On the same day, the UK’s Department of Health announced its support for the AllTrials campaign.
However, both in the UK and Europe, these changes will not do anything to ensure access to information from past trials – the trials that today’s drugs are based on, without which doctors can’t make the best treatment decisions.
We’ve got a fantastic opportunity to change registration and reporting of clinical trials forever - you can help to. Please sign the petition, ask your organization to join, get involved in other ways, and keep up to date with the news.