Fraud & misconduct by Mukesh Jaiswal

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Fraud & misconduct by Mukesh Jaiswal

  1. 1. By: Mukesh Kumar Jaiswal
  2. 2.  Falsification of data in proposing, designing, performing, recording, supervising or reviewing research, or in reporting research results.  Falsification includes both acts of omission (consciously not revealing all data) and commission (consciously altering or fabricating data)
  3. 3.  Fraud does not include honest error  Deliberate or repeated noncompliance with the protocol and GCP can be considered fraud.
  4. 4.  Investigators  Study coordinators  Data management personnel  Lab personnel  IRB staff  CRAs and sponsor personnel  FDA
  5. 5. Study Coordinator Nurse Hospital Sponsor Investigator Office Staff Sub-investigator CRA 39% 17% 9% 9% 9% 9% 4% 4%
  6. 6.  Difficult to determine but still considered rare  Reported to significantly impact 1-5% of pharmaceutical clinical trials.  Only ~3% of FDA inspections uncover serious GCP violations resulting in Warning Letters
  7. 7.  Sponsor – data validity compromised, submission jeopardized, additional costs  Investigator – fines, legal expenses, disqualification/debarment, license revocation, ruined career  Institution – lawsuits  Subject – safety at risk, loss of trust in clinical trial process
  8. 8.  Lack of resources (staff, time, subjects)  Lack of GCP training  Lack of regulatory oversight  Laziness  Loss of interest  Pressure to perform or to publish  Money, greed
  9. 9.  High staff turnover  Staff are disgruntled, fearful, anxious, depressed, defensive  High pressure work environment  Obsession with study payments  Absent investigators  Lack of GCP training  Unusually fast recruitment
  10. 10.  Implausible trends/patterns:  100% drug compliance  Identical lab/ECG results  No SAEs reported  Subjects adhering perfectly to a visit schedule  Perfect efficacy responses for all subjects
  11. 11.  Site data not consistent with other centers (statistical outlier)  Source records lack an audit trail - no signatures and dates of persons completing documentation  All source records & CRFs completed with the same pen  Perfect diary cards, immaculate CRFs
  12. 12.  Subject handwriting and signatures are inconsistent across documents  Questionable subject visit dates (Sundays, holidays, staff vacations)  Impossible events (eg, subject randomized before IP even available at the site)
  13. 13.  Subject visits cannot be verified in the medical chart or appointment schedule  Data contains “digit preference” – some digits used more frequently than others (0, 5, and even digits)
  14. 14.  Expect fraud – start from the assumption that records are bogus.  Question missing, altered, and/or inconsistent data – offer to retrieve records yourself, keep pulling on loose ends.  Don’t be intimidated – challenge to explain suspicious data
  15. 15.  Be suspicious of blame shifting –remind the investigator that he/she is responsible for study conduct.  Cultivate whistleblowers – pay attention to staff complaints, establish rapport, and be approachable.
  16. 16.  Many fraud cases uncovered by staff whistleblowers  Ethical commitment to report fraud:  I recognize my right and responsibility as a clinical research professional to question suspected falsified data, and if necessary, proceed with appropriate reporting procedures as mandated by the appropriate regulatory agencies.  Many institutions have an Office of Compliance with reporting hotlines
  17. 17.  During pre-study evaluation, sponsors should carefully scrutinize sites for interest in the study, stability of the staff, investigator/staff interactions, workload, and level of training.  Everyone involved in the clinical trial process should complete regular GCP training.  CRAs should be expert on the protocol particularly with parameters that determine eligibility (inclusion/exclusion criteria) and primary efficacy endpoints
  18. 18.  Sponsors should emphasize their policy on fraud at the initiation visit  Institutions should set-up systems to encourage fraud reporting and protect whistleblowers

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