Clinical Trial Fraud - How to Identify and Steps to Handle If Found

You are a CRA, CRC, a member of the clinical trial team, CRO, pharma, sponsor, or otherwise - when you become aware of fraudulent data and clinical practices in a clinical trial - what do you do? Immediately report your suspicion and findings to FDA. FDA will direct the "for cause" call to the appropriate divisions at FDA - Divisions of Scientific and Criminal investigations. From here, if fraud is proven, any individual or organisation participating in fraudulent activities will be held to the full extent of the law governing such in the judicial court system.

Clinical trial fraud is on the rise again. Major areas riddled with fraudulent clinical trial behaviour:

• over enrolment of patients
• faking patient informed consent form
• faking patient CRFs
• faking visits
• faking lab data
• under reporting of adverse events
• no reporting of "early patient withdrawals"
• no reporting of "lost to follow-up" patient visits.

If fraud is proven, clinical investigators and anyone involved in the fraud will be given heavy fines as well as prison sentences. Who is at fault? Principle and co-investigators, clinical team members and organisations. It is difficult to prevent the intention of fraud, but it is not difficult to identify fraud. Lack of clinical trial and quality control monitoring allows for the occurrence of fraud.

What does clinical research misconduct, fraud mean? FDA provides a definition that is clear in message and severity. Clinical research misconduct means falsification of data in proposing, processing, designing, performing, recording, supervising, reviewing, analyzing, collecting clinical research or reporting clinical research results, outcomes and endpoints. The manipulation of data and reporting for a self-serving purpose, usually monetary! Simple!

The FDA uses fraud and misconduct interchangeably and includes acts of omission and commission, consciously not revealing all data and consciously altering or fabricating data. Fraud does not include honest error or honest difference in opinion. Deliberate or repeated non compliance with the protocol and GCP is considered fraud, second to falsification of data which is more severe in penalty and justice and resolve.

Let us review again who commits fraud?

• Investigators
• Study nurses
• Study Coordinators
• Data managers
• CRAs
• Sponsors
• Lab personnel
• IRB staff
• Subjects.

Yes, it is true. Clinical trial subjects have been accused and found guilty of fraud. The reasons are interesting and the content of another blog.

Average breakdown in % of blame:

• CRC - 39
• Study Nurse - 17
• Hospital - 9
• Sponsor - 9
• Self - 9
• Office Staff - 9
• PI or Co-PI - 4
• CRA - 4.

Monitor and adhere to GCP. Review and monitor repeatedly. Report fraud.