We were blown away this week by Stat News’ investigation into the blatant underreporting of clinical trials data to the federally mandated ClinicalTrials.gov website. If you haven’t already read this masterful piece of journalism, please do so. No, really. Go ahead and read it. I’ll wait.
I could probably write an entire blog post on any one of ten different elements in that article, but here are the most salient points from our vantage:
- Public reporting of clinical trial study results is required under the law.
- Pharma companies and academic institutions have been late to report or failed to report study results to ClinicalTrials.gov upwards of 95% of the time.
- FDA has the ability to enforce penalties of up to $10,000 per day per trial for late filing, this adds up to $25 billion in potential fines since the law requiring filing went into effect in 2008. In reality, FDA has not fined a single institution for late or missed filings.
- Even FDA’s own staff scientists have violated the reporting law 75% of the time.
- Those conducting clinical trials prefer publication of results in peer-reviewed journals, though those same journals often fail to publish results from failed studies and when they do publish, it is often only available to a tiny paid subscribers list
- ClinicalTrials.gov is open access and meant to be the repository of all study results, not just the positive ones.
Wow. Just wow.
At Advera Health, we’re pretty used to dealing with incomplete data sets. The FDA Adverse Events Reporting System is certainly not without its issues, though it is getting better with time. But this news about the lack of reporting of clinical trial results is simply shocking.
We’ve long argued that post-market data surveillance is a necessary supplement to clinical trials data, but at the same time we’ve understood that controlled clinical trials data are the de facto standard for medical decision making. To know that the organizations and institutions entrusted to conduct clinical trials are flagrantly failing to report their study results – and that FDA is doing literally nothing about it – is stomach turning from a patient safety perspective.
We already know that we can’t rely on FDA to do a good job on post market surveillance, and now I guess we know we can’t rely on them to do a good job on enforcing clinical study reporting either.
It’s all enough to make you want to throw your hands up and scream, “I’m as mad as hell and I’m not going to take it anymore!”
And when you’re done doing that, it’s time to start taking some action.
When we first came across the cluster-f%^k that was FAERS five years ago, we knew there was an opportunity to step in and do something impactful with those data. And we did - just take a look at Journal of Managed Care and Specialty Pharmacy (JMCP) publishing our groundbreaking study entitled “A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes” in its December issue.
And we now know, with complete certainty, that there is a similar opportunity to do something impactful with clinical trials data.
I mentioned in a recent blog post that we’re really only just getting started at Advera Health. I hope you’ll stay tuned in 2016 to see what we have up our sleeves.
Until then, we’re wishing you and yours a happy holiday season.