In theory, human clinical trials are a wonderful thing. For participants, these trials are either their last chance at getting better or selfless acts aimed at helping others who find themselves in similar situations. For the pharmaceutical companies and universities behind the studies, the results are the difference between their next payout and starting off from scratch with something new.
However, in reality, things aren't quite as ideal. Yes, the goals of both participants and conductors do come to pass sometimes, but more often than not, the results from those trials remain in the hands of those who funded them, out of the reach of human volunteers and other researchers who might be working on similar projects.
Now, things are poised to change thanks to a new rule issued by the U.S. Department of Health & Human Services (HHS) and National Institutes of Health (NIH), which seeks "to make information about clinical trials widely available to the public."
There are many aspects of this new rule, but the most significant part is that it now forces researchers to post the results of trials for drugs regardless of whether they make it to the market, as well as require them to publicly disclose whenever side effects of a treatment occur more than 5 percent of the time in the trial.
In addition, the new rules also expand the range of studies that must be publicly registered to include behavioral interventions, require researchers to say in advance how they intend to analyze their results and provide additional details about trial participants (such as race or ethnic background).
There is just one catch: it only applies to studies that have received NIH funding, so privately funded studies are exempted.
To be clear, mandates like this already exist. Back in 2007, a law was passed that required researchers to report results of various human studies of experimental treatments for ailments such as diabetes, cancer and heart disease.
However, a STAT investigation from last year revealed that not only did many researchers not comply with the reporting requirements, but also none of them actually had been fined or penalized — despite the Food and Drug Administration having the authority to do so.
That will change as well: companies conducting FDA-regulated studies will face fines of $10,000 a day if they don't comply with the existing rules. Similarly, universities could see funding withheld entirely until scientists comply with the new rules.
The new rules will come into effect in January 2017. Researchers will have 90 days to comply.
Photo: Justin Ling | Flickr
