Industry and government researchers are not reporting their trial data; what are they hiding?

Wednesday, October 05, 2016 by: Vicki Batts
Tags: clinical trials, HHS, unreported studies

---

(NaturalNews) A study by Duke University conducted in 2015, revealed that only 13.4 percent of trials reported their results within the mandated 12-month time-frame, following the trial's conclusion. In 2007, a law was passed that required certain universities and manufacturers to report their findings, but exemptions and poor enforcement have clearly led to an unsatisfactory result: Almost no one is reporting their data in a timely fashion.

The study was published in a March 2015 edition of The New England Journal of Medicine. One particular point of interest was that a sample review showed that while only 6 percent of trials funded by the National Institutes of Health were not required to report results, a staggering 45 percent of industry-funded trials were not required to report their data. Nearly half of the studies conducted by manufacturers did not have to report the data they found to the FDA. How is that even possible?

The researchers also noted that failure to report data was independently associated with being an industry-funded study as well as a lack of FDA oversight.

In their conclusion, the study authors state, "Despite ethical and legal obligations to disclose findings promptly, most HLACTs [highly likely applicable clinical trials] did not report results to ClinicalTrials.gov in a timely fashion during the study period."

Can you believe that almost half of all applicable industry-funded studies during the researchers' five-year study period were not required to report their data to the FDA? What exactly is going on here? Clearly, there are a lot of study results that no one ever hears about, and you can bet that those studies are probably the ones we need the most. Apparently, it is pretty common for trial administrators to pretend that they didn't think their studies needed to be reported.

While there may be some extenuating circumstances, it is hard to imagine why a study on any kind of medication or chemical wouldn't need to be reported to the government. These are things that affect the health of the people in this country; you'd think that would be enough.

A new rule launched by the Department of Health and Human Sevices (HHS) seems to be seeking to help curtail this glaring issue with transparency and honest reporting. Supposedly, the new rule makes it more difficult to get away with not submitting clinical data. Modern Healthcare writes that the HHS rule will mean that "most interventional trials involving drug, biological and device products need to be registered on ClinicalTrials.gov, and summary results for the studies need to be submitted within a year of a trial's completion." This all sounds great, but "most" is a problematic word. "Most" means there will still be exceptions to the rule, which is kind of how this problem developed in the first place. The HHS notes that a checklist will be made to help trial administrators determine whether or not their trial needs to be reported – but will there be other loopholes?

So, how does the industry feel about these new rules? The Pharmaceutical Research and Manufacturers of America (PhRMA) which is an organization that represents drug makers, has said that it supports "responsible" clinical trial data sharing. What "responsible sharing" means is not described in detail, but it probably means "data that makes the company look good."

While Big Pharma and other industries like Big Biotech do not seem too pleased with the HHS's attempt at increasing transparency, it is very likely that they will find a way around it. They have been hiding a lot of information, and they're going to want to keep it that way. If the government let 45 percent of their studies go unreported before, it wouldn't be surprising if that number stays the same.

Sources:

ModernHealthcare.com

NEJM.org