Restoring the integrity of the clinical trial evidence base | BMJ

"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 Abandoned trials are unpublished trials that sponsors are no longer actively working to publish or published trials that, although documented as misreported, have not been corrected by the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 They challenge medical researchers and funding agencies associated with unpublished or misreported trials to swiftly signal their intent to publish or correct these “abandoned” trials and then to act on this within a year.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....As editors of the BMJ and PLOS Medicine, we endorse the proposal and commit to publishing restorative clinical trial submissions. We encourage other journals to signal their belief in the importance of this effort by endorsing the proposal too, either with an editorial in their journals or by responding to this editorial, encouraging submission of these publications. The results of clinical trials are a public, not a private, good.... "