Whos Paying For That Free Lunch The Management Of Conflict Of Interest In Clinical Practice And Rese

1
Whos Paying For That Free Lunch?The Management
Of Conflict Of Interest In Clinical Practice And
Research

• Paul Komesaroff
• John McNeil
• Shane Carney

Chair Paul Komesaroff
2
Conflict of interest in clinical research

• John McNeil PhD FRACP
• Department of Epidemiology Preventive Medicine
• Monash Clinical School, Alfred Hospital

3
Conflict of Interest
Example surgeon participates in development of
new device provided with shares in
manufacturing company (hospital also) now
proposes trial in which he is chief
investigator IEC response acknowledges
surgeons essential role in implanting
device insists on independent clinician
involvement in patient selection insists on
independent evaluation of subjective
end-points insists on independent evaluation of
data review of publicity
4
Conflict of Interest
PRIMARY INTEREST welfare of patients integrity
of research ( reputation of institution) SECO
NDARY INTEREST financial gain
THE CONFLICT IS A CONDITION, NOT A BEHAVIOR OR
AN OUTCOME
5
Conflict of Interest
Conflict 1 Involvement of investigator in
design, conduct, analysis interpretation Pro
blem Conflict exists because of potential for
financial advantage a particular result is
favourable Risk to patient welfare
scientific integrity Management prohibit
involvement (default) Manage the conflict
6
Conflict of Interest
Conflict 2 Involvement of investigator in
selection of study subjects Problem Conflict
exists because of potential for financial
advantage by selection of borderline
patients Risk to patient welfare reputation
of institution Management prohibit involvement
(default) Manage the conflict
7
Conflict of Interest
Other forms of COI research evaluation
stage publication stage citation review
stage
8
Conflict of Interest
NHMRC / AVACC Statement (2000) Institutions
must have publicise clear policies Disclosure
of full range of potential interests direct
benefits eg sponsorship of research,
travel indirect benefits eg provision of
material or facilities Disclosure to
granting bodies, editors, media reports
9
Conflict of Interest
Victorian standard EC form conferences and
travel bonuses recruitment
incentives consultancies equ
ipment
milestone payments direct payments
patents shares/ share options
board appointments Specify
personal or departmental/institutional
benefit Details justification required for
positive responses Inclusion of statement within
PI sheet
10
Conflict of Interest
11
Conflict of Interest
Issues raised in AMMC report COI officer and
COI committee Disclosure and reporting (unique
approach) De minimus level specified as
10,000 Default position is to avoid
COI alternative is to manage
COI Prohibition on payment for
results Protection of students Sanctions Ins
titutional conflicts
12
Conflict of Interest
Summary rapidly evolving approaches disclosure
essential but not sufficient elimination of
COI preferable concept of advance disclosure
and de minimus levels would help management
of FOI must protect scientific integrity
patient welfare
13
Conflict of Interest
14
Conflict of Interest
All true universities, whether public or private,
are public trusts designed to advance knowledge
by safeguarding the free inquiry of impartial
teachers and scholars. Their independence is
essential because the university
provides knowledge not only to its students, but
also to the public agency in need of expert
guidance and the general society in need of
greater knowledge and . . . these latter
clients have a stake in disinterested
professional opinion, stated without fear or
favor, which the institution is morally required
to respect. American Association of University
Professors, Declaration of principles (1915).