Northern lights
No one in the pharmaceuticals industry today is
in doubt that time is the most scarce resource
in clinical development. However, to make the most
of yours, you don’t want to put study quality
at risk. For this reason, the Scandinavian countries
have been among the preferred regions for
conducting clinical trials for decades. Nordic &
Baltic Medical Advisers (NORMA) tells World
Pharmaceutical Frontiers just why Scandinavia leads
the way in clinical research.
Susanna, the head of the trial team, was anxiously
walking
down the corridor to meet the vice president of
global
development. This morning an email from Peter
in data
management had really made a bad start to the
week:
‘To a large extent, data on the pivotal study
on the compound
PharmI144, which is expected to be the next blockbuster
of
BIGPHARMA Inc, were jeopardised because the tracking
of
patients was lost. The issue was that subjects
included in the
study had been registered in the Clinical Report
Forms (CRFs)
under the same set of initials: AJ, PHS, SFE.
This morning, it was
impossible to consider the full impact of damages,
but an
unacceptable delay was inevitable...’ Running
down the hallway
to her meeting, Susanna could already imagine
the response of
the VP: “How could this happen? How will
you avoid this from
happening again? I need answers, and I need them
fast…”
Scandinavia has a well-established tradition
for clinical
research: major milestones in the treatment of
chronic diseases
such as asthma and diabetes are rooted in the
scientific
culture here. Lately ‘spin-offs’ from
this have created dynamic
centres for oncology research in the Oslo Cancer
Cluster in
Norway and in more than 100 ongoing projects in
The Medicon
Valley (Southern Sweden and Eastern Denmark).
There is
also the internationally renowned Karolinska Institute
in
Stockholm, Sweden.
The region has 30 million inhabitants, who are
served by
570 hospitals, of which 44 have status as university
hospitals.
At all these sites you will find access to a huge
group of
specialists covering many fields (see table).
Following procedure
Filing submissions to ethical committees (ECs)
in the different
countries is no more difficult than filing on
either side of the
Channel – NORMA would argue sometimes even
easier, since
attitudes are similar throughout Scandinavia.
Skilled clinical
research organisations (CROs) will guide you in
picking your
primary investigators at sites to facilitate the
most proactive
discussions with the EC.
As long as you communicate in English, language
will
not be a problem; patient information will need
to be
translated, but other than that you will easily
find your
way around. Fee structures are made very transparent,
the
underlying principle being that as a sponsor you
will pay
only for actual costs incurred. Most hospitals
are publically
owned, and the Nordic governments make it a priority
to strengthen life science research. As a consequence,
overheads will cover administration and you will
not be
charged for aesthetics.
Last but not least, the healthcare systems in
each country assign a unique number to each individual
citizen. This number is constant throughout the
person’s life and prevents any kind of mix-up.
Maybe Susanna will suggest to her boss that the
next part of the clinical programme should be
moved to Scandinavia
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Company profile
NORMA
For further information, visit: www.norma-cro.com
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