Wednesday, November 18, 2009

Clinical Research Fraud - FDA Definition

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.

No comments:

Post a Comment