Last December, Stat News wrote a scathing report on the chronic under reporting of clinical trial results. We followed that up in July with our own blog post, highlighting specific under reporting rates we’ve found in just a handful of indications.
At the time, Vice President Biden learned about the underreporting problem and emphatically proclaimed, “I’m going to find out if it’s true, and if it’s true, I’m going to cut funding. That’s a promise.”
This past Friday, the Department of Health and Human Services rolled out their long awaited final rule on the matter. News coverage in many media sources treated the new rule as the cure-all we’ve been waiting for.
Having now read through the rule, I’m still skeptical.
The civil and criminal consequences of non-reporting in the new rule appear to be exactly the same as the current standard from the FDA Amendments Act of 2007. In very basic English, failure to report findings to ClinicalTrials.gov can result in a fine of up to $10,000 a day and even result in some criminal consequence (what that consequence may be is much harder to determine). In their article, Stat News calculated the total current fines eligible for collection under this system to be over $25 billion since 2008. How much of that has been enforced and collected? None. What’s changed in the new rule announced on Friday? Not much.
The new rule also purports to provide a means to pull NIH funding from institutions that don’t report their clinical trial results in a timely manner. Yet when pressed on just how that would be enacted, the Washington Post reported that Francis Collins, the director of the NIH, “acknowledged that the government cannot ethically halt ongoing clinical trials as an enforcement technique, but he said NIH intends to be vigilant about blocking future grants for institutions that do not comply.”
My takeaway from all of this is that the devil will be in the details. Or, more accurately, the devil will be in the enforcement details. This 700 page (!!) new rule doesn’t really lay out any new penalties or requirements for reporting. It seems to restate the rules that have been on the books since 2007 and says, “This time we really, really mean it.”
At Advera Health, we’ve been working to integrate results from clinical trials into our Evidex real world evidence platform. To date, we’ve included 1,200+ trials covering 170+ drugs across four major indications. Those annotated data from curated clinical trial results provide our clients with the most comprehensive safety focused outcomes database featuring data from trial registries, published research, abstracts, presentations, and more.
In the coming months we have plans to vastly expand our clinical trials coverage. We’re hopeful that starting in 2017 HHS is really going to follow through on the enforcement of the reporting requirements, but based on what they’ve done to date, we’re not exactly holding our breath.
To learn more about how our clients leverage clinical trial outcome results in pipeline and approved drugs to make better safety decisions, click here.
Brian M. Overstreet, President, Advera Health Analytics, Inc.