When a bearded dude at a Brooklyn coffee house says he’s shopping his novel around to agents, no one expects to see it on bookstore shelves in their lifetime. When a scientist says she’s got a pile of data ready to publish, well, that seems like it should see the light of day. But it just as likely won’t.
New research suggests that nearly half of all clinical trials involving kids go unfinished or unpublished — either because the researchers lose interest in the work or take up more pressing projects, or, in some cases, because the companies that funded the studies don’t want the results to get out.
That news won’t come as a surprise to anyone who has followed the fate of studies in general. But it should catch the notice of the FDA: The pharma industry currently gets a special bonus, in the form of extended exclusive marketing rights, for testing their drugs in kids — a rule that was implemented to accelerate research into childhood ailments.
A subsequent law demands that researchers who conduct drug studies in kids post their findings on ClinicalTrials.gov, a federally run database. The registry however, is just a clearinghouse of raw information and represents the bare minimum for reporting data. Few, if any, people without a background in research are going to know how to use it or make sense of what it contains. That’s why publication of studies is so important.
And by not publishing these studies, drug makers and scientists put young patients at risk, particularly if those data reveal dangerous side effects or other adverse events from taking medications.
For the new analysis, the researchers, from Boston Children’s Hospital, looked at 559 randomized controlled trials in children that had been logged in ClinicalTrials.gov between 2008 and 2010. They found that 19 percent were discontinued early, and that 30 percent of the remaining trials were unpublished by September 2015, an average of five years after their completion.
The new findings are virtually identical to those from a 2013 analysis, which found that fewer than half of 600 studies plucked at random from ClinicalTrials.gov were published.
And industry money was a significant predictor of whether data would see the light of day. Studies that received industry funding were more than twice as likely as those with non-industry grants — such as government or foundation money — to be unpublished two years after the end of the project, and more than three times as likely after three years.
In other words, companies are much more likely than academics to run out the clock on results, perhaps because the findings aren’t favorable to their products or because corporate priorities shift over time. It’s a mixed picture, though, when you look beyond just pediatric medicine. Companies are actually slightly better at depositing data in registries overall, according to STAT’s own analysis of the issue.
It’s unclear why researchers don’t publish, although a 2014 paper in PLOS One found that the most common excuse scientists gave was a “lack of time or low priority.” The “file drawer problem” — “Oh, those results aren’t interesting enough for a prestigious journal that can help our careers” — is a real one.
Enough already, say the organizers of AllTrials, a push to get all studies registered, and all data published. “Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet that important ethical principle about reporting has been widely ignored,” say the founders of the initiative, which launched in January 2013. “Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.”
Of course, we know that some researchers will fight tooth and nail to keep their data private, choosing instead to build a wall and make the people asking for data to pay for it. But when even drug company titans see the benefits of putting it all out there, shouldn’t everyone?