Fraud at a Clinical Trial Company in Ohio Highlights Enforcement Challenges 
(Thursday, September 3, 2020]​
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts of financial fraud and falsification of clinical trial records. These charges emanate from an FDA audit and the subsequent federal grand jury investigation. The actual nature of the DOJ and FDA investigation is still not public but per the formal charges filed in the federal courts, these individuals created fictitious patient records, falsified medical records, and stole identities of past acquaintances, all the while billing their clients millions of dollars for services that were apparently never conducted. Several clinical trials contracted to the company were affected by the fraud. The accused include the President and Vice-President of the company, the medical director who also acted as the Principal Investigator on all the trials with violations, the site manager, the clinical coordinator, and the data manager. Most of the accused are related to each other. These were not isolated incidences but a systematic and planned fraud by the entire clinical team hired by the sponsors, which is probably why it kept going for such a long time. Sponsor-contractor relationship is based on immense trust. Most likely each of the eight sponsors conducted due diligence audits over the period of fraudulent activities but could not detect it. The details of how one of the sponsors got suspicious and how the investigators combed through patient records to find patterns such as repeated use of same birth dates and social security numbers for different patient names would be interesting to know when the details are released. The criminals were sloppy at times but probably escaped by spreading their activities across multiple clients and clinical trial projects. The FDA inspectors caught the elaborate fraud by expanding the investigation beyond the one sponsor who initiated. The scary part is that most of the activities would have never been exposed were it not for the use of similar names, birth dates and social security numbers. Which brings us to the scenario of the sponsors here not being more aggressive with auditing records, particularly verifying payment receipts. In this case, the motivation for the fraud seems only to be financial; what if it were to alter results for favorable outcomes. It is critical the trial integrity is verified by the sponsors as FDA cannot be there every time to investigate. This is more the case for non-US clinical trials where patient identification needs to be incorporated in the verification plans while maintaining anonymity of the subjects.