Making the results of all clinical trials accessible to researchers, clinicians and the public not only promotes transparency in clinical research, it also ensures that all the evidence is available for informed clinical decision making. The widespread support for greater transparency in research is perhaps best demonstrated by the huge support garnered by the AllTrials initiative.
However, actually getting all the results published is quite another thing and it’s with this goal in mind that Peter Doshi and his colleagues proposed their initiative Restoring Invisible and Abandoned Trials (RIAT) in the British Medical Journal. Six months on from their publication, the Editors-in-Chief of Trials and the Journal of Negative Results in BioMedicine have written an open letter (which we’ve reproduced below) to almost 200 publication managers in large pharmaceutical companies to follow up on the 12-month ‘grace period’ proposed in the RIAT publication.
In June, Doshi and colleagues published their article ‘Restoring invisible and abandoned trials (RIAT): a call for people to publish the findings’ in the BMJ, inviting independent ‘restorative authors’ to step in and take charge of unpublished or misrepresented trials. This article presented not so much a ‘publish or be damned’ approach as a ‘publish or be published’ one; however, the proposal gave the original triallists and sponsors a one-year grace period to publish the work themselves.
We are writing to declare BioMed Central‘s commitment to supporting and facilitating the publication of all trial results in order to complete the scientific record, and encourage the original triallists and sponsors to publicly state their intent to publish their results and to follow through on that intent. Too many journals do not accept incomplete or negative results so, as the Editors-in-Chief of the BMC Medical Evidence Portfolio’s flagship title Trials and its sister journal the Journal of Negative Results in BioMedicine, we are inviting RIAT authors to submit their ‘restored’ trial reports to us for publication, as we consider all well-conducted, ethical biomedical research, regardless of outcome.
These papers will be considered in the context of our existing publication criteria and, as with any other study, a RIAT study will undergo review by an Associate Editor and external peer reviewers. However, negative or controversial results, or indeed unfinished studies, are no barrier to publication and we provide a simplified format for the reporting of this information, to facilitate publication and ensure that the published record is complete.
We are committed to making the results of all clinical trials accessible to researchers, clinicians and the public, to promote transparency and to make the best evidence available for informed clinical decision making. While we appreciate the difficulties presented by analysing, authoring, peer-reviewing and publishing the trials, if we do not make the effort we will not achieve progress toward the ultimate goal of transparency of clinical trials and access to all available data for making the best clinical decisions. Therefore, we want to appeal to triallists to make this effort to set the scientific record straight. Thank you.
Doug Altman, Curt Furberg, Jeremy Grimshaw and Bjorn Olsen
RIAT is a great idea. While considerable progress has been made in recent years in ensuring that a greater proportion of trials are published, there is no doubt that there is a huge backlog of older trials that were never published, and which are still relevant to today’s medical practice. Anything that gets them into the public domain is to be welcomed.
However, there is a gaping hole in the whole concept of the RIAT initiative, which I have never heard anyone involved in promoting RIAT even acknowledge, let alone try to solve.
Publishing any trial requires considerable resources. This is even more true for old trials where a certain amount of detective work may be involved in piecing together what happened.
Who’s going to pay for it?
Thank you for your comment. I agree entirely regarding the issue of cost and, at present, I feel that this is a huge challenge facing the publication of negative results and clinical trial transparency, in general.
Judging from the widespread support for initiatives, such as the AllTrials initiative, most people seem to agree that publication of all results is an important aspect of evidence-based medicine, but actually getting the job of analysing, authoring, peer reviewing, and publishing the trials done takes considerable resources. This is the goal of the RIATs initiative – rather than simply calling for the data to be published, Peter Doshi and colleagues have proposed that the original investigators either commit to publishing the results themselves or make the data available for others, who have the necessary resources, to publish on their behalf.
I recognise that this approach does not provide a definitive answer to your final question – ‘who is going to pay for it?’ – but by making the data available, it increases the pool of people who have the ability to pay for it.
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