FDA - Consequences of Fraud

The consequences of fraud are pervasive, outreaching and forever. If the Sponsor is found guilty of fraud as per FDA, data validity is compromised and the clinical submission is jeopardized. If the Investigator is involved in the fraud, he or she is disqualified, listed, given fines, incarcerated, incur tremendous legal expenses, he or she has just ruined their career. If the Institution, a Hospital, a Phase 1 Facility, a Clinic, a CRO, IRB or otherwise - is found guilty of fraud - lawsuits. What is the consequence to Subjects enrolled in the Clinical Trial - safety and well being at risk, loss of trust in the clinical trial process, lawsuit.

Facts:

• Fraudulent Investigators are often used by multiple Sponsors on Multiple Clinical Trials.
• Since Investigators are often used by multiple Sponsors on Multiple Clinical Trials, these Investigators will have a broad impact on many clinical submissions made by many Sponsors.
• For example, a case in mind - Investigator F, was involved in 91 clinical submissions with 47 different Sponsors during the same calendar year.
• Why? Word gets around that there are Investigators that "want to see their clinical trial site do the best". Which means that prior to selection of that Investigator, he or she understands how to manage the Subject CRF, Subject Informed Consent and Clinical Trial Protocol, for examples, in order to provide the Sponsor with "higher" statistically and clinically significant subject positive outcomes and better endpoints with respect to the efficacy and safety of the drug on clinical trial.

Why does fraud occur and how does it happen? To mention a few of the most obvious reasons:

• Not enough time
• Not enough staff
• Not enough monitoring, frequency or intensity to detail
• Not enough subjects, so subjects are reused and/or subjects are "made-up"
• Lack of GCP
• Lack of the understanding of GCP
• Lack of training GCP
  
• Lack of training FDA requirements and guidance
• Lack of regulatory oversight
• Lack of interest and motivation
• Money
  
• Greed
• Intent
• Pressure to perform
• Pressure to publish
• Pressure from senior management
• Pressure from piers
• Pressure from political arenas within medical societies, institutions, associations
  
• Pressure from CRO
• Pressure from Sponsor.

FDA Regulations (original statements and updates), pertaining to ("early") actions that must be taken by the Sponsor when fraud, misconduct and noncompliance are suspected or proven, can be found:

• 21 CFR 312.56(b)
• ICH E6 - 5.20.1
• ICH E6 - 5.20.2.
  

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