When a guy with a beard in a cafe in Brooklyn says he is shopping around his agents novel, no one expects to see in bookstores in your lifetime . When a scientist says he has a lot of data ready to publish, so that looks like it should see the light of day. But like probably will not.
New research suggests that nearly half of all clinical trials with children going unfinished or unpublished – either because researchers lost interest in work or opt for more urgent projects, or in some cases because the companies that financed the studies do not want the results out.
That news will not be a surprise to anyone who has followed the fate of the studies in general. But it must be reported to the FDA :. The pharmaceutical industry currently has a special bonus in the form of extended exclusive marketing rights to test their medications in children – a rule that was implemented to accelerate research into childhood diseases
article continues after the announcement
a subsequent law requires researchers conducting drug studies in children published their findings in ClinicalTrials.gov , a database management at the federal level. The record, however, is only an information clearinghouse raw and represents the minimum required for submission of data. Few, if any, people with no background in research will know how to use it or make sense of what it contains. That’s why the publication of studies is so important.
And by not publishing these studies, drug manufacturers and scientists put young patients at risk, especially if these data reveal dangerous side effects or other adverse events taking medications.
For the new analysis, researchers at Children’s Hospital Boston, analyzed 559 randomized controlled trials in children who had been admitted ClinicalTrials.gov between 2008 and 2010. They found that 19 percent interrupted early, and that 30 percent of the remaining trials were not published in September 2015, an average of five years after completion.
The new results are virtually identical to those of an analysis 2013 , which found that less than half of the 600 studies started random ClinicalTrials.gov were published.
And industry money was a significant predictor of whether the data would see the light of day. Studies that have received industry funding were more than twice as likely as people with contributions to the industry – as the government or foundation money -. Be unpublished two years after the end of the project, and more than three times more likely after three years
In other words, companies are much more likely than academics to run out the clock on the results, perhaps because the results are not favorable to their products or because corporate priorities change over time. It is a mixed picture, however, when looking beyond the single pediatric medicine. Companies are actually a little better in the deposit data records in general, according to own analysis STAT of the question.
it is not clear why researchers do not publish, although a role 2014 in PLoS ONE found that the most common excuse scientists gave a “lack of time or low priority.” The “file drawer problem” – “Oh, those results are not interesting enough for a prestigious journal that can help our careers .” – It is real
Enough is enough , say the organizers of AllTrials, a push for all registered studies, and published all data. “Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on the disease, however, that important ethical principle about reporting has been largely ignored,” say the founders of the initiative , which launched in January 2013. “the information on what was done and what was found in these trials could be lost forever doctors and researchers, leading to bad decisions treatment, loss of opportunities for good medicine, and the tests were repeated. ”
Of course, we know that some researchers will fight tooth and nail to keep your private data, choosing instead build a wall and make people asking for information to pay for it. But when even the titans of pharmaceutical companies see the benefits to put it all out there, should not everyone?