According to a notice in the US Federal Register earlier this month Health and Human Services Secretary Kathleen Sebelius charged the Food and Drug Administration (FDA) with monitoring growth of the database – which details both ongoing and completed studies – and with making sure the information it contains is accurate.
Specifically, the FDA has been asked 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.”
Whether the FDA will have sufficient resources to ensure that all the clinical trials required to be reported under US laws are logged on the site is unclear. However, research published in the British Medical Journal (BMJ) earlier this year suggests that the agency faces a considerable challenge.
The authors looked at trials that must be reported under the 2007 FDA Amendments Act (FDAAA) – those that involve a drug, device, or biological agent, which have at least one US site and are at phase II or later – and found that the vast majority were not logged on ClinicalTrials.gov.
“22% had reported results within one year of completion of the trial compared with 10% of trials that were not subject to mandatory reporting,” they said, concluding that “most trials subject to mandatory reporting did not report results within a year of completion.”
A similar conclusion was reached by Congressman Edward Markey (D-Mass) who introduced a Bill to the US House of Representatives – HR 6272 – that called for all studies to be registered on the ClinicalTrials.gov site.
At the time Markey said: “If we were issuing a grade on the clinical trials report card, it would be incomplete” adding that “unreported results and missing registrations leave participants, doctors and researchers vulnerable.
“Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk. I look forward to working with my colleagues on this legislation.”