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Regulatory Compliance


Many device and pharma companies, especially small and midsized firms, may soon face US FDA inspections, warning letters, and even fines for not complying with clinical trial-reporting requirements found in the Food and Drug Administration Amendments Act of 2007 (FDAAA), TrialScope Chief Strategy Officer Thomas Wicks says.

TrialScope is a New Jersey-based firm that helps clinical-trial sponsors improve their disclosure capabilities. (Also see "Clinical Trial Sponsors Take Heed: Study Disclosure Rules Are Expanding" - Medtech Insight, 25 Apr, 2018.)

final rule released by the US FDA in January details requirements for submitting trial registration and summary results information to, as required under Title VIII of FDAAA. 

"The original FDAAA Title VIII regulation was a little ambiguous about what the trial results requirements were … so there was a 'band' in which you could interpret your disclosure requirements," Wicks explained toMedtech Insight. "The final rule tightened that up and made it unambiguous." Wicks said the agency has conducted some pilot audits and will begin inspecting companies for compliance soon. 

"The data are there now," he said. "There's enough information out there and the results volume is increasing with every month. So now FDA has a history against which they can inspect. We do think [the inspections are] going to start later this year, and some companies are already doing external audits to prepare for that."

Trial sponsors are "running out of time to address their noncompliance issues and it's particularly egregious for midsize and smaller companies," he said. Wicks' analysis of the existing data shows that the top 50 companies, in terms of number of trials sponsored, have met their reporting obligations for more than 90% of trials. But the midsized companies – those smaller than the top 50 but with at least 25 trials sponsored each are missing data from about 60% of their trials. The missing-data rate for the smallest companies is about 80%, he said.


The top 50 companies, in terms of number of trials sponsored, have met their reporting obligations for more than 90% of trials. But the midsized companies are missing data from about 60% of their trials and the smallest companies are missing data from about 80%, TrialScope's Thomas Wicks says.

"Once these inspections start, the study volumes may be small, but it's rich pickings for the inspector, especially in the small to midsize companies," he said.

Wicks has tried to break down the data to approximate the relative compliance of organizations focused on device studies versus those focused on drugs or biologics. The data that is currently available does not lend itself to a ready analysis of device versus drug trials, he said, but "based on an initial assessment, it appears that a device sponsor is about 1.3x more likely to be noncompliant than a sponsor of drug or biologics studies." These estimates are based only on US data, he pointed out, because European Union regulations on trial reporting are still much weaker. "The European Medicines Agency has a website [for reporting trial results] and there is really gross noncompliance, especially when it comes to small and midsized industry sponsors," he said. "That's an area that hasn't been written about much, but we're expecting, in the next weeks or months, [to produce] an article analyzing the EU results-compliance, much like the FDAAA tracker."

Also, a recent analysis by Informa's Trialtrove found that unreported clinical trials are more likely to be those in the Phase II stage of development (60% versus 40%), and less likely to be late-stage/Phase IV trials (18% versus 35%). (Also see "The Impact Of Invisible Data: Analyzing Unreported Clinical Trials" - In Vivo, 22 Aug, 2018.)

He said that the agency will likely issue warning letters and give trial-sponsors time to become compliant before issuing fines, but "the expectation is that having a warning like that may discourage people from enrolling in the trial, so it may have a long tail of slowing down clinical development by making it more difficult to enroll people." He added that organizations that rely on grant money from foundations and federal agencies may find it harder to win grants if they are not in compliance.

Wicks pointed out that FDAAA Trials Tracker, an online interactive tool, is publicizing information on company's compliance with these rules. FDAAA Trials Tracker is run by the Evidence Based Medicine DataLab at the University of Oxford in the UK and is connected to the AllTrials campaign led by epidemiologist and science-writer Ben Goldacre. The AllTrials petition, which calls for all clinical trial results to be publicly reported, has been signed by more than 93,000 people and 741 organizations.

FDAAA Trials Tracker applies the methodology of FDA's final rule to publicly available data on clinical trials, and reports which studies are not compliant and how well sponsors – companies and nonprofit research entities – are complying. It also calculates the fine that the FDA could impose on these sponsors if it chooses to fine them following inspections. As of Aug. 22, FDAAA Trials Tracker has found only 747 of a possible 1,249 trials have reported results in compliance with FDAAA, and that the US government could impose over $498m in fines, but so far has not claimed any fines associated with this rule.

"That's an effort to, perhaps, cajole, nudge or shame [these sponsors] and draw attention to the lack of enforcement," Wicks said.

While many trial sponsors are still struggling to meet these reporting requirements, Wicks believes there has recently been an overall shift in attitude toward clinical trial-reporting within the industry. The supporters of AllTrials includes companies that sponsor clinical trials, like GlaxoSmithKline PLC and some investors.

"They could be looking at disclosure practices of smaller and midsized companies," Wicks suggested. "When those companies come looking for funds, the investors may look at that as an indication of whether that's a company they want to invest in."

And more and more companies are trying to not only comply with the law, but make as much information as possible public on their own websites to provide more value to their customers – patients and health-care providers. 

"The general expectation in industry is to be more transparent, center the patients in their communications and engage with the community. One way to do that is to have not only a generous disclosure and transparency practice, but consider how to share data beyond the legal requirements and look at things like plain language summaries and other ways of sharing and providing access to information that is relevant to patients and trial participants," Wicks said. "[Many] sponsors are looking at their own websites and saying, 'You know, we should do more on our website to communicate with patients.' And not just [a list] of studies or links to, but on their own website, providing information about who one can enroll in a trial, what it means to be in a trial, what kind of trials are available,et cetera, and helping people, in a very user-friendly way, to access information on trials."

From the editors of Clinica

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