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PLOS BLOGS Speaking of Medicine

Revealing the Rest of the Iceberg: The Restoring Invisible and Abandoned Trials (RIAT) Support Center & Grant Competitions

Peter Doshi and colleagues announce the formation of the RIAT Support Center and grant competitions aimed at facilitating publication of previously misreported and unreported trials.

Biomedical trial literature is and will remain the evidentiary cornerstone of the endeavour to relieve suffering and prevent disease. But we have come to realise that all is not well in the trial garden.  Not all trials conducted are published (invisible trials) and many trials that are published are inaccurately reported (misreported trials). Something must be done to prevent further erosion of this essential literature and bring hidden trial results to the surface.

RIAT is an initiative aimed at addressing the problems of trial invisibility and misreporting in biomedical literature.  With increasing access to clinical trial data, third parties that had no involvement in the trial (either as investigators or sponsors) can nonetheless obtain sufficient documentation not only to document trial invisibility or misreporting but also to fix the problem, i.e., “restoring” the trial with a new, correctly/adequately reported publication.  RIAT goes beyond just urging investigators and sponsors to “do the right thing.”  It ups the ante by saying “if you won’t publish (or correct, for misreported trials), we will.”

The RIAT initiative believes in “publications with data”, consistent with PLOS’s policy.  While RIAT manuscripts are expected to provide an accurate reporting of a trial, readers should not have to trust the new RIAT publication on blind faith.  The data should be available for anybody to verify the accuracy of what’s reported–whether that’s to spot check or to re-run analyses.

PLOS Medicine has been at the forefront of recognising the issue of invisible and misreported trials (Smith 2005; Rising 2008; Chan 2008; Doshi 2012; Wieseler 2013; Golder 2016; Vedula 2013; PLOS Medicine Editors 2013; Kasenda 2016) and, along with the BMJ, was among the first journals to support the idea of Restoring Invisible and Abandoned Trials (RIAT) back in 2013.

But since 2013 RIAT has made slow progress with only a limited number of restorations, as restoration of a clinical trial is not an easy endeavour. It requires time, investigative skills, and a deep understanding of the topic. We have a set of rules which must be observed: making the case for restoration, accessing the full trial data set, re-analysing it and presenting it, and finally undergoing the usual editorial due process, like any other trial manuscript.

To energise and speed up the process, the Laura and John Arnold Foundation has given RIAT generous support, allowing us to open a virtual, free-of-charge RIAT Support Center to help all would-be restorers with resources, such as explaining the restoration process, accessing data sources and navigating trial and regulatory jargon. The RIAT Support Center is also offering competitive funding to materially help restorers buy the most precious commodity: their time.  Our first competition—open now—offers a single team up to $150,000 USD to complete a trial restoration.

We are also interested in hearing what people know about abandoned trials, and we are especially eager to help ensure the restoration of trials that can have a dramatic impact on clinical practice and public health.  If you know of trial in need of restoring, please get in touch.

RIAT and its Support Center were conceived because we believe that the written record and scholarly activity in biomedicine are too important to be allowed to be submerged or abandoned.

 

Peter Doshi is an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and associate editor at The BMJ.

Larissa Shamseer is a postdoctoral fellow at the University of Maryland Baltimore and a clinical epidemiologist with extensive training and experience in publication science (Journalology).

Mark Jones is a Senior Lecturer in Biostatistics at University of Queensland School of Public Health and Deputy Coordinating Editor of the Cochrane Acute Respiratory Infections Group.

O’Mareen Spence is a Doctoral Candidate in the Pharmaceutical Health Services Research (PHSR) program at the University of Maryland, School of Pharmacy.

Tom Jefferson is a physician, Cochrane author and senior associate tutor at the Oxford University Centre for Evidence Based Medicine.

The authors are from the RIAT Support Center (Web www.restoringtrials.org, Email support@restoringtrials.org, Twitter @RIATinitiative), which provides free-of-charge support and competitive grant funding to researchers interested in restoring the clinical trials’ literature.  The Laura and John Arnold Foundation is a philanthropic organisation that supports the salaries of all the authors. Larissa Shamseer and O’Mareen Spence have no other competing interests.  A complete list of disclosures for Peter Doshi, Mark Jones, and Tom Jefferson is at http://restoringtrials.org/about-us/

Image Credit: Jeff Mikels, Flickr

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