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This is a story of scientists, pharmaceutical sponsors editors of biomedical journals and the lay media. Ultimately you are the target. That is because you are likely to be researchers, consumers or prescribers of lotions and potions.


You are prescribing, researching or consuming on the basis of your knowledge in prescribing drugs, experience in taking them and other bits. The knowledge comes from experience, books and journals read in an effort to keep updated. Personally, trials are my favorite read because they the best way of finding out whether a lotion or potion works and what its possible harms are.


But what if what I read is part of an elaborate marketing strategy to sell us (doctors, researchers and consumers) a particular potion? And what if you discovered that the majority of data on a potion are invisible? And what if you realized that what has been published shows important discrepancies with what probably really went on in a trial? The saturation of scientific literature with commercial messages has come to the point in which some of us who work full time on it trust it no longer. The Tamiflu story (see bmj.com/open data/Tamiflu) proves the point. We cannot get to the bottom of the story.


If we were still at school, the teacher would explain the written mistake and get us to correct it on our copy book.


That is exactly what a group of us are proposing on BMJ and PLOS MED. In the public domain we now have hundreds of highly detailed regulatory reports of trials which were never published (invisible) or distorted in the way the results were presented. Some were even ghost written and we even know who wrote them and for how much money. The sponsors in some cases are refusing to publish them, authors cannot answer questions on the data because they have never seen the full set and have never written the manuscript, and ghost, well they are ghosts. Difficult to identify ectoplasms.


So we are calling for volunteer researchers to do this: pick an invisible or distorted trial and get its report from us, write to the sponsor and ask him to make it visible or correct the record, by responding within 30 days. If they say yes give them 1 year to do it in. If they do not, or turn the offer down, you publish the paper in a RIAT friendly (see below) journal through the usual procedure. You publish the standard 10-15 page paper, plus make the regulatory report (likely to be several thousand pages long) available on the website of the journal, plus you use an Audit Record (called RIATAR) which tracks the bits of the big report you have used in the article. We call this concept RIAT which stands for Restoring Invisible and Abandoned trials.


BMJ and PLOS Medicine have already endorsed the proposal and committed to publishing restorative clinical trial submissions. One more joined the fray yesterday. The specialist journal Headache (http://www.bmj.com/content/346/bmj.f2865?tab=responses). Which is good, because we have clinical study reports of relevant drugs.


This way you can have several published versions of the same trial, with different interpretations and different datasets presented. Unlike what happens now there is free debate based on the data and no one has monopoly control of the whole dataset from the trial. It’s open and it’s potentially good for your health.


If you are a researcher join us, please. Let’s restore the public record.

 

Public link to the RIAT declaration: http://www.bmj.com/cgi/doi/10.1136/bmj.f2865

Public link to accompanying editorial http://www.bmj.com/cgi/doi/10.1136/bmj.f3601

Link PLOSMed blog http://blogs.plos.org/speakingofmedicine/2013/06/13/restoring-invisible-and-abandoned-trials-a-creative-approach-to-a-public-good-now-a-creative-approach-to-implementation-is-needed/


Tom Jefferson