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Oct 10 2012

Clinical Trial Reporting

ClinicalTrials.govOn 26 September 2012, a notice was published in the Federal Register that the Department of Health and Human Services was transferring responsibility to the FDA for ensuring that clinical trial data is appropriately submitted to Clinical Trial Registry and Results Data Bank (which is also known as ClinicalTrials.gov) and that the data is complete and accurate.

In January 2012, a paper published in BMJ found that only 22% of trials had reported results as required on ClinicalTrials.gov.  There have been several high profile scandals in recent years over the lack of adequate reporting of clinical trial data, including the failure of GSK to report complete safety data related to its diabetes drug, Avandia.  GSK agreed to pay $3 billion to resolve the largest fraud and failure to report case ever brought by the US Justice department against a drug company.

The 26 September notice specifically directs the FDA to ensure that all clinical trial data that is required to be submitted to ClinicalTrials.gov is submitted on time and is not “false or misleading”.  If the FDA deems that either of those two stipulations was not met, then it is to notify the responsible party to submit the required information within 30 days of the notification.

Except for phase 1 trials, all clinical trials of drugs, biologics, and devices subject to FDA regulation  must be registered at ClinicalTrials.gov.  More specifically, a clinical trial should be registered if any of the following are true: 1) the trial has one or more sites in the U.S.; 2) the trial is conducted under an Investigational New Drug application (IND) or investigational device exemption (IDE); or 3) the trial involves a drug, biologic or device that is manufactured in the U.S. and is exported for research.

As was mandated by the Food and Drug Administration Amendments Act of 2007, clinical trial information must be submitted to ClinicalTrials.gov no later than 21 days after enrollment of the first subject.  The results of the clinical trial must be submitted no later than 12 months after the trial’s completion date.  Civil penalties can range up to $10,000 per day, and trials that have received federal grants can lose their funding.

It remains to be seen how effective the FDA will be at enforcing their new responsibility as there has been no associated increase in funding or staffing for this endeavor.   However, because of the increase in public scrutiny over clinical trial transparency, the FDA may find their new job under increased scrutiny as well.  It definitely would behoove sponsors to be proactive in registering their clinical trials.