Clinical Trial Fraud

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 organization 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 behavior:

• over enrollment of patients
• faking patient informed consent forms
• 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 organizations.

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.

Monitor. Monitor.