Research Roundtable: FDA Warnings Could Result in Penalties to Investigators Who Fail to Report Results in ClinicalTrials.gov

Research Roundtable.

Food and Drug Administration (FDA) warnings could result in civil monetary and other penalties to investigators who fail to report results on ClinicalTrials.gov. On August 31, the FDA distributed its first Notice of Noncompliance to an individual investigator for failing to report clinical trial results and also featured it publicly on the ClinicalTrials.gov website

For public transparency, U.S. federal law (the FDA Amendments Act of 2007) requires clinical trial sponsors and investigators to register applicable clinical trials and then submit the study results within a year after trial completion. Failure to post results on ClinicalTrials.gov could lead to the FDA issuing a Notice of Noncompliance and if corrective action is not taken within 30 days, the responsible party could be subject to civil money and other penalties including jeopardizing grant funding and future funding to the grantee institution.

Background

ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials conducted in the U.S. and around the world. It is maintained by the National Library of Medicine of the National Institutes of Health. Federal laws and regulations as well as editors of prominent medical journals require registration of clinical trials. The FDA has the authority to issue a Notice of Noncompliance to a submitter who has failed to submit or knowingly submitted false information to the FDA.

Previously, the FDA sent Pre-Notices of Noncompliance to encourage compliance with ClinicalTrials.gov requirements. On April 27, however, the FDA issued its first Notice of Noncompliance to a pharmaceutical company (Acceleron Pharma, Inc.) as the company did not comply with reporting obligations. The following day saw the release of a public statement regarding the failure to submit required clinical trials results information to ClinicalTrial.gov. The FDA gave Acceleron 30 days to submit the required results and warned the company of civil money penalties should it fail to comply within the mandated time frame.

Acting FDA Commissioner Janet Woodcock, MD, emphasized that the FDA would continue to disseminate information associated with noncompliance with ClinicalTrials.gov requirements to ensure the advancement of clinical research to benefit the clinical trial participants and public health.

On July 26, the FDA issued its second Notice of Noncompliance to a pharmaceutical company (Accuitis, Inc.), but it was not until August 31 that such a notice was issued to a principal investigator, Andrey Petrikovets, MD. The notice was issued to Petrikovets, who conducted a study for University Hospitals Cleveland Medical Center (an academic center affiliated with Case Western Reserve University), for not submitting his trial results in a timely manner. (Read more about the warning here.)

The FDAAA 801 violation regarding the failure to submit results was indicated on the public study record in ClinicalTrials.gov, as seen in the picture below.

Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery (ICET)

Clinical trials.

CT.gov Compliance Support at UB

At the University at Buffalo, individual investigators are responsible for entering and updating their study-related information in the ClinicalTrials.gov database. For all UB investigators and their research teams, a UB-specific ClinicalTrials.gov registration and results guide is available on the UB Clinical and Translational Science Institute (CTSI) website. Compliance with ClinicalTrials.gov registration and reporting requirements is monitored by a dedicated team of professionals. UB CTSI members who specialize in ClinicalTrials.gov regularly audit the UB ClincalTrials.gov accounts and routinely remind UB investigators about compliance-related issues.

The UB team are members of the Clinical Trials Registration and Results Reporting Taskforce, a national consortium that serves as a communication forum to provide regulatory support for implementation of clinical trials registration and results reporting requirements in the ClinicalTrials.gov public website. In addition to monitoring compliance, the UB ClinicalTrials.gov team offers continuous support to university investigators who need assistance with account set-up or have questions with registering their trial and/or entering the summary results into the ClinicalTrials.gov repository.

ClinicalTrials.gov establishes one Protocol Registration and Results System (PRS) account for an organization (such as a company, university, or medical center). All investigators from that organization who are conducting studies are designated as users of this single PRS account. UB’s PRS account is SUNYBuffalo. For any questions, contact UB’s PRS administrator, Lynn Jagodzinski, at lynnjago@buffalo.edu

The ClinicalTrials.gov website also features guided tutorials for the PRS, including tutorials for registering the study and entering study results. The PRS results guide delineates the steps and elements required in the study results submission process and addresses common major issues associated with the Results Section of the PRS.

Additional one-on-one assistance from one of the PRS experts for entering study results is available here. More information on Notices of Noncompliance and Civil Money Penalty Actions can be found here.

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI) Translational Spotlight newsletter. Add your email to the newsletter mailing list here.