The FDA will begin policing compliance with clinical trial submission requirements for ClinicalTrials.gov under a policy change at HHS. Previously, HHS verified the completeness and accuracy of the information on the site.
A late-September Federal Register notice states the responsibility has now transferred to the FDA and charges the agency with identifying incorrect or fraudulent submissions and seeking out unsubmitted trial results. The FDA is directed to notify sponsors who haven’t submitted results and demand that they do so within 30 days. The agency will not receive any additional funding for the new responsibility and will use existing appropriations to carry out related tasks.
The NIH maintains ClinicalTrials.gov, a clinical trial registry data bank, in accordance with the Public Health Service Act. However, academic studies — including a prominent study published in the January 2012 British Medical Journal — found that as few as 22 percent of completed studies are added to the database as required. That report created a new public push for compliance.
Are you compliant when registering your trials on ClinicalTrials.gov? New legislation is also pending in the House to increase reporting requirements and also step up penalties. When the inevitable compliance hammer falls, will you be crushed, bruised or completely out of harm’s way?
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