Friday, November 27, 2009

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.

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