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Middle East Fertility Society Journal
Middle East Fertility Society
ISSN: 1110-5690
Vol. 12, Num. 3, 2007, pp. 216-217
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Middle
East
Fertility
Society
Journal,
Vol.
12,
No.
3,
2007,
pp.
216-217
EVIDENCE-BASED
MEDICINE
CORNER
Evidence
of
influence:
how
to
avoid!
Hesham
Al-Inany,
M.D.,
Ph.D.
Code
Number:
mf07041
Increasingly,
biomedical
studies
receive
funding
from
commercial
firms,
private
foundations,
and
government.
The
conditions
of
this
funding
have
the
potential
to
bias.
Bias
comes
about
when
the
findings
of
research
appear
to
differ
in
some
systematic
way
from
the
true
result
(1).
Other
research
studies
have
suggested
that
funding
is
a
source
of
bias;
studies
sponsored
by
drug
companies
seem
to
more
often
favor
the
sponsor's
drug
than
trials
not
sponsored
by
drug
companies
(2,
3).
The
question
that
should
be
asked,
why
drug
companies
would
be
interested
in
clinical
trials!!
Many
clinical
trials
are
performed
to
facilitate
regulatory
approval
of
a
device
or
drug
rather
than
to
test
a
specific
novel
scientific
hypothesis.
It
is
estimated
that
the
average
cost
of
bringing
a
new
drug
to
market
in
the
United
States
is
about
$500
million
(4).
The
pharmaceutical
industry
has
recognized
the
need
to
control
costs
and
has
discovered
that
private
nonacademic
research
groups--that
is,
contract
research
organizations
(CROs)--can
do
the
job
for
less
money
and
with
fewer
hassles
than
academic
investigators.
How
to
avoid
such
influence!!!
First,
scientists
have
an
ethical
obligation
to
submit
creditable
research
results
for
publication.
As
the
persons
directly
responsible
for
their
work,
researchers
therefore
should
not
enter
into
agreements
that
interfere
with
their
access
to
the
data
or
their
ability
to
analyze
the
data
independently,
to
prepare
manuscripts,
and
to
publish
them.
Authors
should
describe
the
role
of
the
study
sponsor(s),
if
any,
in
study
design;
in
the
collection,
analysis,
and
interpretation
of
data;
in
the
writing
of
the
report;
and
in
the
decision
to
submit
the
report
for
publication.
(http://www.icmje.org/sponsor.htm)
Second,
to
encourage
conducting
RCTs,
Why,
because
randomized
controlled
trials
are
generally
considered
to
be
the
most
reliable
type
of
experimental
study
for
evaluating
the
effectiveness
of
different
treatments.
Randomization
involves
the
assignment
of
participants
in
the
trial
to
different
treatment
groups
by
the
play
of
chance.
Properly
done,
this
procedure
means
that
the
different
groups
are
comparable
at
outset,
reducing
the
chance
that
outside
factors
could
be
responsible
for
treatment
effects
seen
in
the
trial.
When
done
properly,
randomization
also
ensures
that
the
clinicians
recruiting
participants
into
the
trial
cannot
know
the
treatment
group
to
which
a
patient
will
end
up
being
assigned.
However,
despite
these
advantages,
a
large
number
of
factors
can
still
result
in
bias
creeping
in
RCts
(5).
Third: to
conduct
a
systematic
review
of
RCTs
and
to
do
a
sensitivity
analysis
between
studies
with
and
without
funding.
Unfortunately,
two
recent
systematic
reviews
of
the
impact
of
financial
conflicts
on
biomedical
research
found
that
studies
financed
by
industry,
although
as
rigorous
as
other
studies,
always
found
outcomes
favorable
to
the
sponsoring
company
(1,
6).
This
could
not
be
explained
by
the
reported
quality
of
the
methods
in
research
sponsored
by
industry.
The
result
may
be
due
to
inappropriate
comparators
or
to
publication
bias.
Thats
why
meta-analysis
has
got
the
top
of
the
evidence
hierarchy.
REFERENCES
-
Lexchin
J,
Bero
LA,
Djulbegovic
B,
Clark
O.
Pharmaceutical
industry
sponsorship
and
research
outcome
and
quality:
systematic
review
.
BMJ.
2003
May
31;326(7400):1167-70.
-
Tungaraza
T,
Poole
R. Influence
of
drug
company
authorship
and
sponsorship
on
drug
trial
outcomes.
Br
J
Psychiatry.
2007
Jul;191:82-3.
-
Brown
A,
Kraft
D,
Schmitz
SM,
Sharpless
V,
Martin
C,
Shah
R,
Shaheen
NJ.
Association
of
industry
sponsorship
to
published
outcomes
in
gastrointestinal
clinical
research.
Clin
Gastroenterol
Hepatol.
2006
Dec;4(12):1445-51.
Epub
2006
Nov
13.
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Mathieu
MP.
Parexel's
Pharmaceutical
R&D
Statistical
Sourcebook,
1998.
Waltham,
MA:
Parexel
International
Corp.;
1999
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Peppercorn
J,
Blood
E,
Winer
E,
Partridge
A.
Association
between
pharmaceutical
involvement
and
outcomes
in
breast
cancer
clinical
trials.
Cancer.
2007
Apr
1;109(7):1239-46.
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Bekelman
JE,
Li
Y,
Gross
CP.
Scope
and
impact
of
financial
conflicts
of
interest
in
biomedical
research:
a
systematic
review.
JAMA
2003;289:
454-65
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