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FDA Given New Authority to Oversee Clinical Trials Data Reporting

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By Alexander Gaffney

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement.

Under section 801 of the Public Health Service Act (PHSA), as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institutes of Health (NIH)'s National Library of Medicine (NLM). The website serves as a unified hub for the oversight of clinical trials, and includes information regarding the sites where a trial is conducted, the general design of a study and information about its sponsor.

Though much of the registry deals with industry-run trials in support of a drug, device or biologic regulatory submission to FDA, DHHS has until now maintained general ownership of the registry and website, including responsibility for making sure all required data is submitted on time.

That ownership is now partially changing hands, writes DHHS Secretary Kathleen Sebelius.

Under changes announced on 25 September by Sebelius, Hamburg—and by extension, FDA—will be transferred DHHS' authority under the PHSA to, "determine that any clinical trial information was not submitted as required under 42 U.S.C. 282(j) or was submitted but is false or misleading in any particular and to notify the responsible party and give such party an opportunity to remedy non-compliance by submitting required revised clinical trial information not later than 30 days after such notification."

This will involve mostly industry actors, but could also come to include the NIH, which conducts numerous trials. Earlier research published in the British Medical Journal (BMJ) found that less than half of clinical trials conducted using NIH funding reported the results of clinical trials to the registry within three years—two years more than the mandatory time frame. Overall, just 22% of trials reported within one year, a separate study, also published in the BMJ found.

It remains unclear whether FDA will require additional resources to conduct this oversight and, if so, where such funding would originate.




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