British Medical Journal
22 June 2013 (Vol 346, Issue 7913)
Restoring the integrity of the clinical trial evidence base
Calling researchers and editors to help restore invisible and abandoned trials
Elizabeth Loder, clinical epidemiology editor 1, Fiona Godlee, editor in chief1, Virginia Barbour, chief editor2, Margaret Winker, senior research editor2 VB and MW: on behalf of the PLOS Medicine editors
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3601 (Published 13 June 2013)
Public confidence in the credibility of medical research is at a low ebb.1 2 3 4 Many completed clinical trials have never been published, and many published results are incomplete or misleading.5 6 7 This crisis of hidden or misreported information from clinical trials—and the resulting distortion of the clinical evidence base—is widely recognized and commonly decried.8 It is one of the leading scientific problems of our time, but few solutions have been put forward.
In a linked Analysis article (doi:10.1136/bmj.f2865), Doshi and colleagues offer a bold remedy in the form of the RIAT (restoring invisible and abandoned trials) proposal.9 Invisible trials are those that have never been published. Abandoned trials are unpublished trials that sponsors are no longer actively working to publish or published trials that, although documented as misreported, have not been corrected by the authors. Doshi and colleagues declare that, “because abandonment can lead to false conclusions about effectiveness and safety, we believe that it should be tackled through independent publication and republication of trials.” They challenge medical researchers and funding agencies associated with unpublished or misreported trials to swiftly signal their intent to publish or correct these “abandoned” trials and then to act on this within a year. If no such intention is declared, or if a corrective paper has not been published within a year, they propose offering the opportunity to become “restorative authors” to other responsible researchers, who would restore the integrity of the reporting of the trials involved…