1. Market Report
Volume 5 Issue 424 Journal for Clinical Studies
Asia nowadays is considered definitively as the
fastest-growing market, and a consolidated area for drug
development. Asia not only offers the highest number of
treatment-naïve patients able to participate in trials, and
a steady improvement of regulations, but it also offers the
lowest trial cost in the world. As part of this trend, Taiwan
has developed and continues to show the world its unique
capabilities for clinical trials. Herein, we would like to show
the potential and clinical research environment of Taiwan,
considering selected critical cross-points while conducting
clinical trials.
Study Management & Subject Recruitment
One can consider that the diversity in languages can
be a burden while conducting trials in Asia. However,
communication should not be an issue, considering that most
of the management involved in a trial should and can speak
professional applied English or Chinese. A good example
of this situation is Taiwan, where the majority of medical
records, guidelines and daily research interaction is done in
English.
Asia is expected to account for 60% of the world’s
populationby20501
.Thishugepopulationpresentsadistinctive
opportunity for recruitment of patients into clinical trials.
It is no secret that Asian countries are characterised by their
diversity in terms of population segments, disease patterns,
literacy rates, and mortality rates, which very often offer a
sufficient pool of research subjects. This factor, considered
along with the demography, infrastructure upgrading
and grade of compliance with research standards, help
us to understand why Asian countries are more involved in
large-scale and pivotal trials in comparison with past decades.
For example, according to the ClinicalTrials.gov website,
between April 2008 and March 2011, 33.8% and 17% of all
Phase III and II trials respectively were conducted in Asia.
All these features make Asian countries, and especially those
which have all the above advantages (Taiwan, Korea, China)
as potential key centres for conducting clinical trials in Asia.
Regulatory Affairs
The environment surrounding the regulation of drugs and
devices in Asian countries has shown steady improvement in
recent years.
Figure 1 Timeline for IND and NDA in China, Taiwan and Korea.
Clinical trial facilities in China have been working
on streamlining government regulations and becoming
aligned with international standards of practice. The
Korea FDA (Food and Drug Administration) also revised
their KGCP in 2000, separating the IND (Investigational
New Drug) process from the combined IND/NDA (New
Drug Application) to streamline the IND review system
in 2007. The Taiwan health authority (TFDA) has also
been reformed to improve the efficiency of the process
from policy planning to execution, and to increase
administration efficiency. In 2010, TFDA set up fast-track
(priority, abbreviated) review processes for IND and NDA.
For INDs, the fast-track review process was issued for
trials that have the same FDA-approved IND number
as in the US, or for multi-national INDs issued by ICH
member states. The fast-track review process for NDAs has
shortened the review process time by up to two-thirds
for studies considered as targeting unmet medical needs
and/or with clinical advantages. In addition, for new
chemical entities approved by USFDA or EMA, the
expected NDA approval time has been reduced to half of
the previous review period.
Figure 2 Pharmaceutical Regulations in Taiwan
Clinical Research Environment
in Taiwan
Source: CFDA, TFDA, KFDA
websites.
Timeline information in
parenthesis is based on real-time
experience. A+ Inc. files.
Source: TFDA website.

2. Figure 3 Lower Trial Costs in Asia-Pacific
Source: Optimer Pharmaceuticals, Inc. Economic Cooperation
Framework Agreement: Potential for Taiwan/China Biopharma.
Mar 2011.
Clinical Research Cost
The cost for conducting a trial in Asia-Pacific is much
lower than in other regions. Figure 3 shows the average
principal investigator’s total cost2
. Investigator and site fees
are approximately one-half of those in the United States.
Cost savings of global clinical trials in Asia could be resulting
from the following factors: further costs to the sponsor
for providing trial-related medication, investigations,
and hospitalisation could be as low as 30% of those in
America. Domestic travel costs for monitoring sites are lower
because of the concentration of sites in the major cities and
comparatively less costly fares and tariffs. Support services,
such as printing, translation, and local courier fees are also
less expensive3
. By means of the high quality clinical research
resources and relatively low costs, there are more and more
international companies conducting their clinical trials in
Asian countries.
Logistics & Supply of Clinical Materials and Sample
Management
With the growing complexity of clinical trials, more
challenges will need to be overcome in managing the clinical
trial material supply chain. Clinical research organisations
(CROs) are now been tasked with managing clinical supply
chains, which lead to a strategic relationship between CROs
Figure 4 More industries conducting their clinical trials in
Asian countries
and clinical supply chain service providers. Cooperation with
a regional CRO can help to set up efficient and applicable
supply chains to adapt to potential and current supply
challenges.
In conclusion, Asia offers a standard streamlined clinical
trial environment which, along with all the cost-effective
variables involved, should lead to any serious industry player
considering Asia - especially those developed regions such as
Japan, Taiwan, Korea, and China - as a natural niche for drug
development and marketing expansion.
Market Report
Journal for Clinical Studies 25www.jforcs.com
Penny Chen, PhD in biopharmaceutical
science is a medical writer in A+ Inc. A+ Inc.
is a unique Asian regional CRO dedicated to
assistsponsorsworldwidefordrugdevelopment
and marketing. As a part of the PPC Group,
A+ Inc. is committed to win recognition as a
sustainable and critical partner of the pharmaceutical
industry in Asia.
Email: penny.chen@apluscro.com