FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov
The FDA issued a Notice of Noncompliance on August 31, 2021, to Andrey Petrikovets, M.D. (responsible party) affiliated to University Hospitals Cleveland Medical Center, for failing to submit required summary results information to ClinicalTrials.gov. The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the first notice was issued. The company’s applicable clinical trial compared ICE-T postoperative multimodal pain regimen to the Standard regimen in patients undergoing same day vaginal pelvic reconstructive surgery.
The prenotice was issued on July 20, 2020, alerting Andrey Petrikovets to potential noncompliance with the requirement to submit clinical trial results. Although the trial’s results were made public in a medical journal, journal publication does not satisfy ClinicalTrials.gov disclosure requirements. On November 30, 2020, Andrey Petrikovets responded, stating that they were very busy with the “Covid surge” and were short staffed. FDA recognizes the unique circumstances that the pandemic presents, and believes they have provided ample opportunity to submit the required results information. The Notice of Noncompliance gives Andrey Petrikovets 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Andrey Pretrikovets’s violation, including additional civil money penalties if Andrey Petrikovets fails to submit the required information within the 30-day period.
The Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance has also been posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed if any.
For more information, please refer to the Letter of noncompliance on the FDA Website: Non-compliance letter