The US Food and Drug Administration (FDA) is now charged with making sure companies submit all required data for clinical trials of drugs and medical devices. In a notice published Wednesday in the Federal Register, the US secretary of health and human services delegated its monitoring authority to the FDA.
The mandated information is supposed to be filed in www.clinicaltrials.gov, a registry that describes ongoing and past clinical trials and is run by the US National Institutes of Health and National Library of Medicine. Entries describe what diseases are being studied, where and how. Most clinical trials in the United States (and many outside it) are recorded, but results of these trials are often missing.
An analysis published this year found that only 22% of completed trials reported results within a year, as required. Another analysis found that results of fewer than half of trials had been published in the peer-reviewed literature 30 months after publication. In other words, many results of clinical trials — even those financed with federal funding — do not become public.
Whether transferring oversight to the FDA will result in greater reporting is unclear, however. An account from the Regulatory Affairs Professional Society noted that the FDA’s additional authority does not come with additional funding.
Nor is it clear what the penalties might be. The FDA now has the authority to determine that data submitted for a clinical trial are missing, false or misleading, and to then notify the responsible party to “remedy non-compliance”.
However, a blog post by pharmaceuticals reporter Ed Silverman says that the shift in authority could make a difference. “The move is likely to be more than symbolic, given the scandals that have ensued in recent years over a failure to provide complete trial data.”