Considering Asian clinical trials?
By following a procedure of analysis, planning,
execution and closure, a making Asia a desirable
location for clinical trial sponsors. However,
before they and their CRO partners rush into starting
or expanding an Asian clinical programme, both
parties should first address several strategic
issues.
With every aspect of drug development moving
east,
there are only two kinds of clinical trial sponsors:
those running sites in Asia, and those thinking
about running sites in Asia.
For the latter, Asia appears from afar an impenetrable
black
box. While that box is rumoured to hold significant
cost savings
and access to the fastest-growing healthcare market
in the world,
tapping into it means navigating regulatory and
operational
challenges compounded by language barriers.
Even for drug developers with established clinical
trial sites
in Asia, expanding from one country to the next
can pose
challenges. Each country has its own distinct
cost structure,
population base, medical practice standards, infrastructure,
government policies and cultural differences.
Before delving into or expanding an Asian clinical
programme,
trial sponsors and their CRO partners should discuss
several
strategic issues.
Cost considerations
Running trial sites in China, Thailand, the Philippines
or
Malaysia can save a sponsor 60% compared to running
equivalent sites in the U.S. Most countries in
Asia are at least
20-30% more cost-efficient than their western
counterparts.
But there are exceptions to every rule: for instance,
investigator
salaries and other trial costs in South Korea
can be just as high
as in the western world.
The numbers game
With more than four billion people, Asia offers
sponsors a
deep pool from which to draw clinical trial participants.
Yet
sponsors of late-stage trials in indications such
as diabetes
or cardiovascular disease must balance population
benefits
with increasing competition for enrollment in
countries such
as China, Indonesia, Japan, the Philippines, Thailand
and
Malaysia. A country such as South Korea is less
populous,
but may also offer less competition.
Evaluating medical practice
There are certain diseases for which the standard
of care in
Asia is similar to that in the West, including
breast cancer, lung
cancer and diabetes. But for many indications,
medical practice
standards differ both from east to west and between
the different
Asian regions. Sponsors seeking to mirror Western
standards may
want to consider limiting their trial sites to
countries such as
Singapore, Taiwan, Hong Kong and South Korea.
Getting the job done
Sponsors should be prepared that Asian trial sites
may need more
assistance when it comes to following protocol
and differentiating
between medical practice and clinical research.
Similarly, sponsors
should not assume that all potential Asian trial
sites will have the
infrastructure – even fax machines or freezers
– needed for a
clinical trial.
Political factors
Each Asian country’s policies on protocol
approvals, insurance
regulations, import licences and other factors
can affect a sponsor’s
success. The regulatory bodies in South Korea,
Taiwan and
Singapore have adopted an FDA flavour to their
practices. Yet each
Asian country has its own regulatory idiosyncrasies
– in China, for
example, a sponsor should never assume that what
worked in one
application will be directly applicable to another.
The cookie-cutter
approach simply isn’t feasible.
Cultural considerations
Once language barriers are overcome, sponsors
are often pleased to
learn that investigators in most Asian countries
are eager to
participate in clinical research. Regulatory reviewers,
too, are often
eager to help, if a sponsor knows what questions
to ask and how to
ask them. Yet there are certain cultural considerations
sponsors
need to address upfront with their investigators,
such as
procedures for publicising findings from the trial.
A question of ethics
As the fastest-growing pharmaceutical market in
the world, China
is a major consideration in the marketing plans
of most drug
developers. Yet if a sponsor has no plans to launch
a drug in certain
Asian countries, then conducting clinical research
in those
countries may present ethical challenges.
The right CRO partner is aware of such ethical
considerations
and can guide sponsors through these and other
issues. While
challenging at first, Asia’s rewards in terms
of rapid enrollment,
cost-savings and market access are not just upside
– they are
essential to remaining competitive in the drug
development world
of today and tomorrow.
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