Rake, Bastian and Haeussler, Carolin
(2019)
Did
relaxing
clinical
trial
regulation
enhance
the
stock
of
scientific
knowledge
in
India?
Not
necessarily.
PLoS ONE, 14 (1).
ISSN 1932-6203
Abstract
The
increasing
amount
of clinical
research
conducted
outside
the
“traditional”
countries
raises
questions
about
the
benefits
of hosting
offshored
clinical
research.
The
extent
to
which
trials
contribute
to the
scientific
knowledge
base
and,
in particular,
whether
there
are
differences
between
different
types
of trials
remain
open
questions.
By
examining
a change
in clinical
trial
regulations
in India,
a country
often
viewed
as
a first-choice
offshoring
loca-
tion,
we
study
how
the
relaxation
of clinical
trial
regulations
affects
the
number
and
the
type
of clinical
trials
as
well
as
the
domestic
scientific
knowledge
base.
Based
on
trial
data
from
ClinicalTrials.gov
and
data
on
associated
publication
activities,
our
empirical
analysis
sug-
gests
that,
despite
an
initial
increase
in the
number
of clinical
trials,
relaxing
clinical
trial
reg-
ulations
has
a limited
impact
on
the
domestic
scientific
knowledge
base.
More
specifically
,
the
number
of Indian
researchers
involved
in the
production
of trial-related
scientific
knowl-
edge
remains
modest.
Furthermore,
the
potential
to learn
from
the
additional
trials
appears
to be
limited:
the
influx
of phase
3 trials—mainly
sponsored
by
Western-pharm
aceutical
firms—is
accompanied
by
a lower
likelihood
that
the
trial
results
will
be
used
in Indian
researchers’
subsequent
research
activities
when
compared
to phase
3 trials
with
preceding
phase
2 trials,
as
was
required
before
the
regulatory
change.
Overall,
our
results
contradict
expectations
that
relaxing
the
regulatory
requirements
for
conducting
late-stage
clinical
tri-
als
is an
appropriate
means
of supporting
the
development
of the
domestic
scientific
knowl-
edge
base.
| Item Type: |
Article
|
| Keywords: |
relaxing
clinical
trial; regulation enhance; scientific knowledge;
India; |
| Academic Unit: |
Faculty of Social Sciences > School of Business |
| Item ID: |
10415 |
| Identification Number: |
https://doi.org/10.1371/journal.pone.0210163 |
| Depositing User: |
Bastian Rake
|
| Date Deposited: |
09 Jan 2019 13:03 |
| Journal or Publication Title: |
PLoS ONE |
| Publisher: |
Public Library of Science |
| Refereed: |
Yes |
| URI: |
|
| Use Licence: |
This item is available under a Creative Commons Attribution Non Commercial Share Alike Licence (CC BY-NC-SA). Details of this licence are available
here |
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