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2 March 2020

Is Your Clinical Trial in Compliance with ClinicalTrials.gov (If Not, It Could Cost You)

Written by Liz Bloss

ClinicalTrials.gov is the largest database of clinical trials in the world. It reportedly holds information about more than 318,000 trials covering more than 200 countries. Managed by the U.S. National Library of Medicine, this vast resource was created to afford the public better access to the enormous amounts of information garnered through clinical trials.

You’re Required to Register. It’s the Law.

The law that established ClinicalTrials.gov requires that sponsors provide information about . . .

  • Federally and privately funded clinical trials

  • The purpose of each experimental drug

  • Eligibility criteria for trial participants

  • The location of clinical trial sites

  • A point of contact for patients interested in enrolling in a trial

 It sounds straightforward, yet sponsors often fail to comply. Some trials are not registered at all. In the case of others, information is not appropriately updated over time. In still other situations, the information reported to ClinicalTrials.gov differs significantly from the information that appears in peer-reviewed journal articles regarding the same studies.

 

Research by Bracken Data, a sister company to the Bracken Group, has shown that the rate of compliance is 70.6% for studies that are recruiting, and only 35.4% for all studies.

 

Why Sponsors Fail to Comply

There are reasons beyond negligence for non-compliance. For example, busy teams may push the ClinicalTrials.gov registration to the back burner when their to-do list is long. Sponsors that make an initial posting on the site often forget about updating it as necessary. And, because submitting information into the data base is challenging, sponsors with the best intentions frequently make mistakes in attempting to post information.

Health and Human Services and the National Institutes of Health have both pushed in years for stronger enforcement of compliance, and there have been a number of initiatives from both the government and industry to step up regulation. As a result, the risks involved for sponsors who fail to comply have risen enormously.

 

Non-Compliance Could Cost You

The 21st Century Cures Act, signed into law in December 2016, includes possible penalties of as much as $500,000 for organizations operating trials that are not in compliance. A draft guidance released by the FDA in September 2018 suggests a one-time penalty of as much as $10,000 for any violation “adjudicated in a single proceeding.” If a violation is not corrected within 30 days following the sponsor’s notification of it, penalties can accrue at a rate of $10,000 per day for each violation until it is corrected.

Penalty-worthy violations include . . .

  • Failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank

  • Submitting false or misleading information

  • Failing to submit the required certification to FDA

  • Knowingly submitting a false certification to FDA

At the Bracken Group, we find that the two most common violations are failure to keep studies updated and failure to provide results.

 

Know Where You Stand. Get the Help You Need.

What can sponsors do to avoid violations and the risk of penalties? One approach is to work with an expert consultant who knows the ins and outs of the registration process and can make sure that your trial is in compliance — and stays in compliance through to its conclusion. In addition to assuring that you avoid penalties, a knowledgeable consultant can also advise you on more nuanced issues surrounding registration, such as the business advantages inherent in registering later or sooner.

Finally, sponsors should know that they can — and should — check whether or not they are in compliance. Bracken Data offers the service for free. Learn more about it here.

 

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