Drugs

‘Objectionable Conditions’ in 2 Clinical Trials

A 12/6-12/15/2022 FDA inspection at a clinical trial site operated by Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, found objectionable conditions in the conduct of two clinical investigations. An 11/8 Warning Letter says it appears that Hoppers did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act and applicable federal regulations governing the conduct of clinical investigations and the protection of human subjects. The inspection was part of the agency’s Bioresearch Monitoring Program.

The letter emphasizes that Hoppers failed to ensure that the investigations were conducted according to the investigational plan.

It says Hoppers responded that the issues found at the trial site “were attributed to a clinical research coordinator for this study. You stated that before the FDA inspection, you had self-reported this issue to the institutional review board, the state nursing board, and the sponsor’s medical monitor.”

Hoppers reported that the site management organization she partnered with had hired a new clinical research director who was charged with developing a quality management system and updating internal processes and standard operating procedures (SOPs).

FDA acknowledges the actions Hoppers took but says her response was inadequate because she did not provide sufficient details on how she, as a clinical investigator, would ensure adequate supervision and oversight of study personnel to whom study procedures and tasks were delegated. The agency also requests copies of the new SOPs.

“We emphasize that as the clinical investigator, you were ultimately responsible to ensure that your clinical study was conducted properly and in compliance with FDA regulations, both to protect the rights, safety, and welfare of study subjects and to ensure the integrity of study data,” the letter says. “Your failure to ensure that subjects met protocol-required inclusion criteria, and your lack of oversight and supervision of the clinical study, raise significant concerns about the safety of study subjects enrolled at your site, and about the integrity of the data generated at your site.”

Hoppers was told to respond with a list of specific actions she has taken to prevent similar violations in the future.

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