This document discusses clinical trial fraud, including definitions, common types of fraud, perpetrators, frequency, impacts, red flags, and recommendations. It notes that fraud includes falsification of data through both omission and fabrication. Common perpetrators include study coordinators, nurses, and investigators. Red flags include implausible or perfect data patterns, inconsistent subject documentation, and questionable visit dates. Recommendations include assuming fraud until proven otherwise, cultivating whistleblowers, and emphasizing fraud policies.

1. By:
Mukesh Kumar Jaiswal

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.  Fraud does not include honest error
 Deliberate or repeated noncompliance with the
protocol and GCP can be considered fraud.

4.  Investigators
 Study coordinators
 Data management personnel
 Lab personnel
 IRB staff
 CRAs and sponsor personnel
 FDA

5. Study Coordinator
Nurse
Hospital
Sponsor
Investigator
Office Staff
Sub-investigator
CRA
39%
17%
9%
9%
9%
9%
4%
4%

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.  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.  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.  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.  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.  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.  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.  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.  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.  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.  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.  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.  Sponsors should emphasize their policy on
fraud at the initiation visit
 Institutions should set-up systems to
encourage fraud reporting and protect
whistleblowers