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Cochrane signs up to AllTrials initiative to campaign for registration and reporting of all clinical trials

The AllTrials initiative (All Trials Registered | All Results Reported) was launched in January 2013 to draw attention to the issue of unreported trial data. Hundreds of thousands of clinical trials have been conducted from which no or limited data have been made available; these data are critical to enable doctors and regulators to make informed decisions about treatment. This is a serious problem for evidence-based healthcare researchers, including The Cochrane Collaboration, because Cochrane Review authors need all the evidence about a treatment in order to fully understand its harms and benefits. Without a complete picture of trial results available, information is lost, bad treatment decisions may be made, opportunities for better and more effective treatment are missed, and trials are repeated unnecessarily, duplicating effort and wasting resources.

In the three months since its inception, the AllTrials initiative has gathered more than 48,000 signatures, as well as the support of hundreds of organizations and institutions working in research, patient advocacy and health care. The Cochrane Collaboration was one of the earliest organizations to offer support, and to further demonstrate its commitment to the goals of the AllTrials initiative, as of April 2013 has formalized its involvement as one of the initiative’s principal supporters and organizers.

“Patients around the world are being harmed because clinical decisions on their health care are skewed by the absence of clinical trials data,” said Mark Wilson, CEO of The Cochrane Collaboration, in announcing this new partnership. “For 20 years The Cochrane Collaboration has been working to give clinicians, researchers and patients the best possible evidence-based information to help them make informed decisions, and it is a scandal that we still do not have access to all trials data so that we can be confident in our conclusions. By taking this step, we hope to emphasize to Cochrane contributors worldwide that, through working together to maximize the impact of our collective voices, we can achieve as much in this area as in our work to produce Cochrane Reviews.”

Given the relevance of this campaign to The Cochrane Collaboration’s work, all Cochrane contributors are encouraged to familiarize themselves with the AllTrials initiative’s rationale and goals; to sign the petition; and to consider ways of bringing this campaign to the attention of their own local networks and institutions. Individual Cochrane contributors are already actively involved in advocacy work to publicize these issues:

  • In February 2013, a group of UK-based contributors made a submission to the Science and Technology Committee of the UK House of Commons, requesting that appropriate measures be taken to ensure comprehensive publication of clinical trial data; following on from this submission, AllTrials founding member Ben Goldacre was invited to speak before the Committee in April 2013.

  • Since 2010, Peter Gøtzsche, Director of the Nordic Cochrane Centre, has been working to raise awareness among members of the European Parliament involved in the revision of the Clinical Trials Directive, which is currently underway, and to promote the inclusion of not only summaries of results of drug trials, but also study reports and raw anonymised patient data. This addition, intended to enable re-analysis by independent researchers, is in line with the European Medicines Agency’s proposed requirements for new drug applications from January 2014.

  • Tom Jefferson, a Cochrane Review author, continues to seek access to full study reports on the influenza drug oseltamivir, an endeavour that prompted the BMJ to launch its Open Data campaign late in 2012 (see links under ‘Related reading’ for more information).

For more information and resources, and to sign the petition, please visit the AllTrials website. To make a financial contribution to support the campaign, please visit the AllTrials fundraising page.

Related reading

Updated on: December 23, 2013, 12:19

Comments for improvement or correction are welcome.