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The Characteristics of Clinical Trials in Asia
Brooks-Rooney C, Wong GKW, Hamerslag L, Costello S
Costello Medical Consulting Ltd, Cambridge, UK
Introduction
Results
In 2011, China and Japan recorded pharmaceutical
market growth rates of 22% and 16% respectively,
compared to 3% in the USA.1 This highlights
the potential opportunities in Asia compared
to traditional markets.
Figure 1: Total number of trials and trials per 1m population for each country
The aim of this research was to identify recent
clinical trials in Asia to determine the countries
leading the clinical trial growth, the most common
disease areas considered and the most common
trial sponsors.
Methods
ClinicalTrials.gov was searched for trials
initiated after 01/01/2010 in the following Asian
countries: Indonesia, South Korea, Malaysia,
Taiwan and Thailand.
The results were reviewed and the following
aspects were analysed:
•Most common diseases
•Most common trial sponsors
•Percentage of trials in adults versus
in children
hese figures were then compared between
T
the different countries.
Number of Trials
In response to this trend Western pharmaceutical
companies must now incorporate Asian
populations into their clinical trial designs for
global drug launch plans, in order to improve
access to Asian markets. Therefore there has
been a steady increase in the number of clinical
trials conducted in Asian countries.2
2,000
40.0
Number of Trials
Trials per 1m Population
1,500
30.0
1,000
20.0
500
10.0
0.0
0
South
Korea
Taiwan
Thailand
Trials per Country
Malaysia
Trials per 1m Population
medical consulting
Indonesia
In particular, type 2 diabetes was highly
represented in the trials.
The number of trials per country is
summarised in Figure 1. The figure shows
both the total number of trials in each country,
as well as the calculated number of trials per
1,000,000 population.
Trial Populations
In all countries, the majority of trials were
conducted in an adult population (between
65% and 84%), which is similar to the
proportion in the USA, 81%.
From Figure 1 it is clear that there are
substantial differences between the countries.
Whilst South Korea has the highest number of
trials, Taiwan has the highest proportion of trials
per 1m population: 35.6 compared to 32.6
for South Korea. This compares to a figure of
50.4 for the USA. In Thailand, Malaysia and
Indonesia the numbers of trials and trials per
1m population are substantially lower.
Sponsorship
The majority of trials in Malaysia and
Indonesia were industry-sponsored,
whilst Taiwan and Thailand had the lowest
proportions of industry-sponsored trials
(see Table 1). Local medical institutions
(e.g. university hospitals) sponsored over
40% of trials in Taiwan, 30% in Thailand
and 18% in South Korea. Major multinational
pharmaceutical companies were the main
sponsors in Malaysia and Indonesia.
Disease Areas
The most common trials in all countries were
for chronic conditions, with the top 3 most
common disease areas researched in clinical
trials presented in Table 1.
Table 1: Summary of the characteristics of the clinical trials in each country
Top disease researched
2nd disease researched
3rd disease researched
Proportion of trials in adults
Proportion of industrysponsored trials
South Korea
Taiwan
Thailand
Malaysia
Indonesia
CAD
Gastric cancer
T2D
84%
T2D
Schizophrenia
Liver cancer
81%
T2D
HIV
Influenza
74%
T2D
RA
Haemophilia A
84%
T2D
Liver cancer
Malaria
65%
47%
37%
39%
72%
54%
T2D Type 2 Diabetes, CAD Coronary Artery Disease, HIV Human Immunodeficiency Virus, RA Rheumatoid Arthritis
Discussion
There are clear differences in the characteristics
of clinical trials being completed in Asian countries.
Taiwan has the highest number of trials per capita
out of the countries investigated, followed closely
by South Korea. The figures for Thailand, Malaysia
and Indonesia are much lower. To some extent,
this may be related to wealth: 2011 GDP per
capita in Taiwan and South Korea was $37,720
and $31,714 respectively, compared to $9,396,
$15,568 and $4,666 in Thailand, Malaysia
and Indonesia.3
In South Korea, Taiwan and Indonesia, the
majority of trials are not industry-sponsored, and
4 of the top 5 sponsors are national academic
institutions. In Malaysia and Indonesia however,
Copyright © Costello Medical Consulting Limited
international pharmaceutical companies account
for 4 of the top 5 trial sponsors. This suggests
that in countries with a higher number of trials,
there is a higher proportion of national-sponsored
academic trials, potentially linked to wealth but
also to expertise in conducting trials.
The most common disease areas being
investigated are chronic diseases, in particular
T2D. This could be a reflection of the general
global case (in the USA trials in chronic disease
are also the most common) but may also reflect
the increasing importance of chronic diseases
in Asia, and the increasing importance of
investigating the responses of Asian populations
to medications for these diseases in particular.
In summary, the Asian pharmaceutical market
presents huge opportunities for growth, which
are being availed by companies through the
increasing numbers of clinical trials being
conducted in Asian countries.
References
1 IMS World Review 2012 www.imshealth.com
2Wong et al. ISPOR 5th Asia-Pacific Conference
Podium Presentation HC4
3 International Monetary Fund 2012
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