Today, I read an article in Dickinson’s FDA Webview (here; subscription required) titled “Clinical Researchers Plead Guilty to Fraud” that has the following rather chilling opening line: “Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs designed to treat asthma.” This piqued my interest, so I decided to look back at the FDA Debarment List (here) to see how many debarments for commission of clinical trial fraud were finalized in 2023 and 2024. I concentrated only on clinical trial fraud because of several recent high-profile cases in which Warning Letters had been issued that largely focused on data integrity issues uncovered in clinical studies as well as articles I’ve come across on the topic, such as this and this. Also, I’ve seen the FDA’s persistent warnings reminding application sponsors that they are ultimately responsible for all data submitted to the FDA in drug applications, including that of their development partners, which includes any and all data generated at any CRO that the sponsor may engage with during clinical development. (You can listen to a presentation from the FDA on this topic here.)
So, what is debarment? Pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) or (b)), persons may be debarred permanently or for a specified period of time from providing services in any capacity to a person who has an approved or pending drug product application if they are convicted of a crime associated with drug development. The length of time of debarment is based on the severity of the illegal activity associated with that person’s actions.
It is also noteworthy that it takes a good amount of time for a debarment to occur after the person is found guilty of a crime for which a debarment is applicable. Debarments can occur for all kinds of illegal activities, such as mail fraud, providing false data to the FDA in an application, or making a false statement to the FDA, just to name a few. However, for the purposes of this blog, I was specifically interested in those people who had been debarred for clinical trial fraud.
I searched the FDA debarment list cited earlier for debarments associated with drug product applications. I found a total of ten debarment notices for individuals (five in 2023 and five in 2024). While this does not seem like a lot, just imagine how many clinical trials these ten individuals could have been involved with. If you use the FDA CDER search engine and query “fraud in clinical trials,” the number of hits may astound you!
In an article written by Dr. Ashwaria Gupta (here), he states that “Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence.”
Clinical trials are vulnerable to fraud and selection of your CRO, as well as the investigators, sub-investigators, and other contracted entities involved in your clinical investigations, should be closely monitored to avoid any compliance issues, particularly data integrity issues. Clinical investigations and bioequivalence studies are a significant expense for application sponsors; compromising the underlying data could invalidate those studies and risks requiring repeat studies, at significant additional expense, to support approval of your applications. Keep vigilant in monitoring your contractors and look for the “watch outs” or hot-button items that may signal a problem.
