01/03/2024
Photo by: Canva
On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
The FDA Warning Letter highlighted the following protocol violations:
Subjects were concurrently or consecutively enrolled in studies which should have excluded each other.
Criteria regarding subjects' diagnoses, their participation in other studies, and the use of prohibited medications were not followed.
The investigator didn’t exclude subjects correctly based on eligibility criteria.
Subjects were enrolled in studies despite having medical conditions that made them ineligible. In one case, a subject was using a prohibited medication while participating in the study. The site was aware of this but failed to take corrective action. Furthermore, the investigator enrolled study participants earlier than outlined in the protocol. The protocol required participants be enrolled 12 weeks after the completion of another study of systemic investigational product. The investigator’s response indicated that they were observational studies when in fact they were randomized, controlled studies assessing safety outcomes. It is a regulatory responsibility per 21 CFR Part 312.60 for investigators to follow the protocol as written to ensure the safety of study participants and the integrity of the data, and they agree to this when submitting their FDA Form 1572 and when signing the protocol.
In addition to protocol violations, there was a failure to maintain accurate and adequate case histories that detailed diagnoses and concomitant medications for subjects in one of the protocols. Inaccurate concomitant medication lists could lead to safety concerns or a missed ineligibility. Even after acknowledging the errors, the response was still deemed inadequate due to the lack of supporting documentation and assurance of corrective actions.
The FDA emphasized that these failures in maintaining the investigation in accordance with the protocol and failure to ensure subjects meet eligibility criteria cast doubt on the protection of study participants and integrity of the data collected at the site.
The full Warning Letter is available on the FDA’s website HERE.
-The Clinical Pathways Team
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