Strategies for Detecting Clinical Trial Fraud

Monitor the data.
Monitor the monitor.

What do you monitor - what do you ask for when doing an audit? What detection tactics and strategies work?

• Ask for all subject information (data, docs, records) pertinent to the clinical study:

1. CRFs
2. Source worksheets
3. Clinical charts
4. Sign-in sheets
5. Lab requisitions
6. Shipping records.

• Accept no copies -

1. Review originals whenever possible.

• There is no easy way, don't just inventory and log, use your experience and understanding - Read -
  

1. Lab reports
   
2. X-rays.

• Fraud exists, expect fraud on an audit - assume fraud - work backwards.
• Question data, question and follow "open-ended data", "loose-ends" -
  

1. Missing
2. Altered
3. Inconsistent.
   

• Don't be timid - challenge the site to explain suspected fraudulent data.
• "Blame-shifting" during onsite audits "for cause" is pervasive.
  
• Be suspicious and challenge the investigator and remind he or she that clinical study conduct and GCP sits with them.
• Find and engage and cultivate "whistleblowers" - pay attention to -
  

1. Staff complaints
2. Listen to grievances
3. Establish rapport be approachable
4. Follow your leads
5. Don't stray from the data - the data is the data
6. Watch for changes in clinical staff behaviors
7. The list is endless.

GCP is well documented and simple to follow - unless there is serious intent to do otherwise. Detect clinical fraud early in data at a clinical site. The ramifications of doing so saves time and perhaps the integrity of the clinical study and/or clinical submission but most importantly protects subject safety, for those subjects that are real.