| The consequences of fraud are pervasive, | | | | Why does fraud occur and how does it happen? To |
| outreaching and forever. If the Sponsor is found | | | | mention a few of the most obvious reasons: |
| guilty of fraud as per FDA, data validity is | | | | - Not enough time |
| compromised and the clinical submission is jeopardized. | | | | - Not enough staff |
| If the Investigator is involved in the fraud, he or she | | | | - Not enough monitoring, frequency or intensity to |
| is disqualified, listed, given fines, incarcerated, incur | | | | detail |
| tremendous legal expenses, he or she has just ruined | | | | - Not enough subjects, so subjects are reused and |
| their career. If the Institution, a Hospital, a Phase 1 | | | | or subjects are "made-up" |
| Facility, a Clinic, a CRO, IRB or otherwise - is found | | | | - Lack of GCP |
| guilty of fraud - lawsuits. What is the consequence to | | | | - Lack of the understanding of GCP |
| Subjects enrolled in the Clinical Trial - safety and well | | | | - Lack of training GCP |
| being at risk, loss of trust in the clinical trial process, | | | | - Lack of training FDA requirements and guidance |
| lawsuit. | | | | - Lack of regulatory oversight |
| Facts: | | | | - Lack of interest and motivation |
| - Fraudulent Investigators are often used by multiple | | | | - Money |
| Sponsors on Multiple Clinical Trials. | | | | - Greed |
| - Since Investigators are often used by multiple | | | | - Intent |
| Sponsors on Multiple Clinical Trials, these Investigators | | | | - Pressure to perform |
| will have a broad impact on many clinical submissions | | | | - Pressure to publish |
| made by many Sponsors. | | | | - Pressure from senior management |
| - For example, a case in mind - Investigator F, was | | | | - Pressure from piers |
| involved in 91 clinical submissions with 47 different | | | | - Pressure from political arenas within medical |
| Sponsors during the same calendar year. | | | | societies, institutions, associations |
| - Why? Word gets around that there are | | | | - Pressure from CRO |
| Investigators that "want to see their clinical trial site | | | | - Pressure from Sponsor. |
| do the best". Which means that prior to selection of | | | | FDA Regulations (original statements and updates), |
| that Investigator, he or she understands how to | | | | pertaining to ("early") actions that must be taken by |
| manage the Subject CRF, Subject Informed Consent | | | | the Sponsor when fraud, misconduct and |
| and Clinical Trial Protocol, for examples, in order to | | | | noncompliance are suspected or proven, can be |
| provide the Sponsor with "higher" statistically and | | | | found: |
| clinically significant subject positive outcomes and | | | | 21 CFR 312.56(b) |
| better endpoints with respect to the efficacy and | | | | ICH E6 - 5.20.1 |
| safety of the drug on clinical trial. | | | | ICH E6 - 5.20.2. |