TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance
US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties – and it looks like SMEs will be hardest hit.
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A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.
Despite the scientific, social and ethical implications of withholding clinical trial data, which have been widely debated in the public arena, many studies remain unreported according to data from the AllTrials initiative and Trialtrove.
The recent update of Title VIII of the Food and Drug Administration Amendments Act of 2007 clarifies the requirements for registering clinical trials and disclosing trial results to US FDA, but many trial sponsors and investigators are still confused about their obligations under these rules, as well as the rules governing clinical trial registration and disclosure abroad. Francine Lane, the VP of global transparency at TrialScope, talked to Medtech Insight about the challenges facing clinical trial sponsors trying to comply with these rules and offered some predictions about how these regulations will likely evolve in the future.