Restoring Invisible and Abandoned Trials (RIAT) Proposal

Restoring Invisible and Abandoned Trials (RIAT) proposal published in the British Medical Journal suggests that all clinical trials including those that are abandoned or considered “invisible” be published.1 “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 Abandoned trials are unpublished trials that sponsors are no longer actively working to publish or published trials that, although documented as misreported, have not been corrected by the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.”2 The proposal challenges the researchers and funding agencies to publish all of their data, even the clinical trials that were not completed. Failing to publish within a year would open the arena up to publication by “restorative authors” who would publish the data to further promote transparency in medical research.2

Some drug companies are under attack and involved in litigation for reporting bias. For example the compound Gabapentin (Neurontin®) marketed by Pfizer to treat epilepsy and neuropathic pain was approved based on only 12 of its 20 trials.1,2 In addition to gabapentin, the antidepressant paroxetine (Paxil®), antipsychotic quetiapine (Seroquel®), and the influenza drug oseltamivir (Tamiflu®) are also proposed for further examination by scientists as compounds in which all available data has yet to be published.

For Forensic Toxicologists involved in death and criminal investigations the unpublished data may provide further information on adverse effects of drugs that we may not have been aware of. However, huge obstacles such as distilling the copious amounts of clinical trial data into the restrictions imposed by journals which is estimated of a compression factor of over 1000:1.2 That said, the potential for is great for a more comprehensive evaluation of drug data as it relates to adverse effects, death investigations and impairment interpretation.

Doshi P, Dickersin K, Healy D, Vedula SW, Jefferson T. “Restoring invisible and abandoned trials: a call for people to publish the findings.” BMJ2013;346:f2865. http://www.bmj.com/content/346/bmj.f2865 Accessed 15 June 2013

Loder, E., Godlee, F, Barbour, V., Winkler, M. “Restoring the integrity of the clinical trial evidence base.” British Medical Journal. BMJ 2013;346:f3601 http://www.bmj.com/content/346/bmj.f3601 Accessed 15 June 2013