a
Registered clinical trials (x10
3
) Registered clinical trials (x10
3
)
0
50
100
150
200
250
300
350
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
Africa
Latin America
Oceania
North America
Europe
Asia
United States
Other high
income: OECD
High income:
non-OECD
Upper-middle
income
Lower-middle
income
Low income
b
Registered clinical trials (%)
0
40
30
20
10
50
60
70
80
90
100
2005
2006
2007
2008
2009
2010
2011
2012
c
0
50
100
150
200
250
300
350
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
d
Registered clinical trials (%)
0
40
30
20
10
50
60
70
80
90
100
2005
2006
2007
2008
2009
2010
2011
2012
Organizations that conduct clinical trials are
increasingly using global networks to reduce
costs and accelerate recruitment. Because the
migration of clinical trials from countries
such as the United States to other countries
where the health-care infrastructure is less
developed has public health, economic, social
and ethical implications, we explored a large
repository of open-access trial registry data to
understand changes in the global distribution
of clinical trials.
We examined data on 205,455 clinical
trials from 15 global primary trial registries,
conducted in 163 countries from 1999 to
2012 (Supplementary information S1, S2
(boxes)). The first 6 years (1999–2004)
represented just 8% of all registered trials,
and numbers increased sharply in 2005 after
the introduction of registration requirements
by the International Committee of
Medical Journal Editors (ICJME) (FIG. 1a).
The 30,964 clinical trials registered globally
during 2012 represented a 66% increase
from the 18,692 trials registered during
2005.
Clinical trials were classified by
geographical region. Over the 2005–2012
period overall, 127,314 (67%) of the 189,213
registered trials were conducted in the United
States, Canada or Europe (see Table 2 in
Supplementary information S2 (box)).
The United States was the single largest
country conducting clinical trials, with
58,980 trials (30%). The absolute increase
was greatest for the Asian region (489%)
and the Latin American/Caribbean region
(112%); the smallest increase occurred in
the North American region (9%) (FIG. 1b).
Clinical trials were also classified by the
economic development status of the countries
involved. Over the 2005–2012 period overall,
77% of trials were conducted in the group
of 24 high-income OECD (Organisation for
Economic Co-operation and Development)
countries, including the United States (FIG. 1c;
see Table 2 in Supplementary information
S2 (box)). From 2005, absolute growth was
highest among lower-middle-income (594%)
and low-income (247%) countries (FIG. 1d).
Meanwhile, high-income non-OECD and
high-income OECD countries excluding the
United States had increases of 36% and 59%,
respectively. There was an 11% increase in
the absolute number of trials conducted in
the United States, but the proportion of trials
globally decreased from 35% in 2005 to 24%
in 2012. The proportion of registered trials
globally increased in low-income (2% to
5%) and lower-middle-income (4% to 16%)
countries (P < 0.0001).
The highest average clinical trial densities
over the 2005–2012 period were in North
America, Europe and Oceania, as well as
in high-income OECD and non-OECD
countries. The 48 low-income countries
averaged 0.3 trials per 10
6
people, or one
clinical trial for every 3 million people.
Denmark had the highest average trial
density (107 trials per 10
6
people), and other
high-density countries included Estonia, the
Netherlands, Israel and Finland (see Table 5
in Supplementary information S2 (box)).
The largest average annual growth rate
from 2005 to 2012 occurred in Asian (30%)
and Latin American/Caribbean (12%) regions;
other geographic regions had growth rates
that were lower than the global average (8%;
see Table 2 in Supplementary information S2
(box)). The largest average annual growth
occurred in lower-middle-income (33%)
and low-income (21%) regions. Emerging
economies among low-middle-income
countries (such as Iran, China and Egypt)
had the largest country-specific growth; other
countries with high growth rates included
South Korea, Japan, India, Brazil and Turkey
(see Table 6 in Supplementary information S2
(box)). The United States had an average
annual growth rate of 2%.
Overall, the data show that the number
of registered clinical trials has increased
TRIAL WATCH
Global migration of clinical trials
Figure 1 | Global migration of clinical trials. The total annual number of registered clinical trials
between 1999 and 2012 (part a) and percentage distribution between 2005 and 2012 (part b) by
United Nations geographic region. The total number of trials is 205,455, and includes Africa (3,983),
Latin America (8,117), Oceania (10,418), North America (75,128), Europe (66,396) and Asia (41,413).
The total annual number of registered clinical trials between 1999 and 2012 (part c) and percentage
distribution between 2005 and 2012 (part d) with countries classified by the World Bank economic
development category. Data for United States and other high-income OECD countries are shown
separately. The total number of trials is 213,331, and includes the United States (69,007), other
high-income OECD countries (94,844), high-income non-OECD countries (10,201), upper-middle-
income countries (12,621), lower-middle-income countries (19,648) and low-income countries
(7,010). For details of the data and analysis, see Supplementary information S1 (box).
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166 | MARCH 2014 | VOLUME 13 www.nature.com/reviews/drugdisc
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