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Fraud & Misconduct at Investigator Sites

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Fraud & Misconduct at Investigator Sites Paul Below Clinical Research Consultant P. Below Consulting, Inc. SoCRA 15th Annual Conference Chicago, IL – PowerPoint PPT presentation

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Title: Fraud & Misconduct at Investigator Sites


1
Fraud Misconduct at Investigator Sites
  • Paul Below
  • Clinical Research Consultant
  • P. Below Consulting, Inc.
  • SoCRA 15th Annual Conference
  • Chicago, IL
  • September 23, 2006

2
Disclosure Disclaimer
  • I have a consulting relationship with the
    following companies
  • MGI Pharma
  • Medical Research Management
  • Minneapolis Heart Institute Foundation
  • The views expressed here are my own and I am
    solely responsible for the content of this
    presentation

3
Presentation Topics
  • Definition of fraud
  • Prevalence
  • Famous cases
  • Consequences
  • Reasons why fraud occurs
  • Warning signs/identifiers
  • Detection strategies
  • Fraud prevention

4
FDA Definition of Fraud
  • 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)

5
Fraud Definition (cont.)
  • Fraud does not include honest error or honest
    differences in opinion
  • Deliberate or repeated noncompliance with the
    protocol and GCP can be considered fraud, but is
    considered secondary to falsification of data

6
Who Commits Fraud?
  • Investigators
  • Study coordinators
  • Data management personnel
  • Lab personnel
  • IRB staff
  • CRAs and sponsor personnel
  • FDA

7
Who Gets Blamed?
4
4
39
9
9
9
9
17
Source FDA Presentation, DIA 2000
8
Prevalence of Fraud
  • Difficult to determine but still considered rare
  • Reported to significantly impact 1-5 of
    pharmaceutical clinical trials F. Wells,
    Reuters Health, January 2002
  • Only 3 of FDA inspections uncover serious GCP
    violations resulting in Warning Letters

9
Famous Cases - Investigators
  • Robert Fiddes, MD Private practice, Whittier, CA
    1997
  • Richard Borison, MD and Bruce Diamond, PhD
    Medical College of Georgia 1998
  • Michael McGee, MDUniversity of Oklahoma, Tulsa
    2000
  • Maria Kirkman (aka Ann Campbell), MDPrivate
    practice, Alabama 2003

10
Famous Cases - Coordinators
  • Anne ButkovitzPediatric private practice,
    Newton, MA 2005
  • Paul KornakStratton VA Medical Center, Albany
    2005

11
Robert Fiddes, MD Of Mice and Men, 60
Minutes, April 1, 2001
12
Richard Borison, MD Drug Money, 48 hours,
July 31, 2000
13
Richard Borison, MD Drug Money, 48 hours,
July 31, 2000
14
Bruce Diamond, PhD Drug Money, 48 hours, July
31, 2000
15
Bruce Diamond, PhD The Lessons of Greed,
PharmaVOICE, July 2004
16
Paul Kornak Abuses Endangered Veterans in
Cancer Drug Experiments, New York Times,
February 6, 2005
17
Consequences of Fraud
  • Sponsor data validity compromised, submission
    jeopardized, additional costs
  • Investigator fines, legal expenses,
    disqualification/debarment, license revocation,
    incarceration, ruined career
  • Institution lawsuits
  • Subject safety at risk, loss of trust in
    clinical trial process

18
Consequences (cont.)
  • Fraudulent investigators are often used by
    multiple sponsors on multiple trials
  • A small number of investigators can have a broad
    impact on many NDA submissions
  • One fraudulent investigator, Dr. Fiddes, was
    involved in 91 submissions with 47 different
    sponsors

19
Dr. Fiddes and staff on the FDA Debarment List
20
Federal Register Notice for Study Coordinator
Debarment
21
Why Does Fraud Occur?
  • 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

22
General Warning Signs
  • 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

23
Data Identifiers of Fraud
  • 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

24
Layout the primary efficacy data for all subjects
at a site to look for trends
25
Data Identifiers (cont.)
  • 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

26
Source British Medical Journal, 2002 324
1193-1194
27
Data Identifiers (cont.)
  • Subject handwriting and signatures are
    inconsistent across documents (consents, diaries)
  • Questionable subject visit dates (Sundays,
    holidays, staff vacations)
  • Impossible events (eg, subject randomized before
    IP even available at the site)

28
Data Identifiers (cont.)
  • 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)
  • Halo around the date or test value indicating
    the original was obliterated with correction fluid

29
Detection Strategies
  • Expect fraud start from the assumption that
    records are bogus and work backwards
  • Question missing, altered, and/or inconsistent
    data offer to retrieve records yourself, keep
    pulling on loose ends and see what unravels
  • Dont be intimidated challenge to explain
    suspicious data

30
Detection Strategies (cont.)
  • Be suspicious of blame shifting remind the
    investigator that he/she is responsible for study
    conduct
  • Cultivate whistleblowers pay attention to staff
    complaints, listen to grievances, establish
    rapport, and be approachable

31
Whistleblowers
  • Many fraud cases uncovered by staff
    whistleblowers
  • Ethical commitment to report fraud (SoCRA)
  • 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
  • US government encourages whistleblowers through
    False Claims Act awards

32
False Claims Act
  • Unlawful to submit a false or fraudulent claim
    for payment to the United States government
  • Private citizens who know of people or companies
    defrauding the government may sue on the
    government's behalf (qui tam relator)
  • Plaintiff shares in the proceeds of the suit
    (15-30 of amount recovered by government)
  • Contains protections for whistleblowers who are
    harassed, threatened, discharged or otherwise
    discriminated against in their employment

33
Recent False Claims Act settlement with the Mayo
Clinic (Rochester, MN)
34
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35
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36
Cherlynn Mathias - University of Oklahoma
Melanoma Trial Whistle Blower
37
Fraud Prevention
  • 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

38
Fraud Prevention (cont.)
  • Sponsors should emphasize their policy on fraud
    at the initiation visit
  • Institutions should set-up systems to encourage
    fraud reporting and protect whistleblowers

39
  • This presentation and related references are
    posted on my corporate website atwww.pbelow-con
    sulting.com/fraud.html

40
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41
Thanks
  • Kerrin Young, Study Manager, Takeda, and Jeri
    Weigand, Quality Assurance Auditor, 3M
    Pharmaceuticals, for their collaboration in the
    development of this presentation

42
Contact Information
  • Office (952) 882-4083
  • E-mail paul_at_pbelow-consulting.com
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