Clinical Investigator Warned for ClinicalTrials.gov Noncompliance
A Los Angeles doctor is the first individual investigator to receive an FDA warning letter for failing to report trial results to ClinicalTrials.gov, a violation that could result in thousands of dollars in fines, the letter said.
In an Aug. 31 letter, the agency warned Andrey Petrikovets that he had 30 days to submit to the ClinicalTrials.gov registry results of a phase 4 postoperative pain-relief trial he conducted at the University Hospitals Cleveland Medical Center. The trial concluded in June 2018 and the agency first notified Petrikovets of his noncompliance in a July 20, 2021, letter.
Petrikovets submitted the results to ClinicalTrials.gov one day after receiving the warning letter, sidestepping a potential fine of at least $10,000 for every day he was in noncompliance. According to the registry’s website, the information is currently undergoing quality control review before being posted.
The Petrikovets letter is the third such warning the FDA has given for noncompliance with ClinicalTrials.gov requirements. Previously, the agency cited two trial sponsors — Acceleron Pharma and Accuitis — for the same violation (CenterWatch Weekly, Aug. 23).
Read the warning letter at https://bit.ly/3C3n8Uz.