Emerging Markets
Latin America: ripe for clinical research?
As clinical trial sponsors increasingly shift their radars towards the emerging economies of Latin
America, Francesca Bruce garners local knowledge from key industry figures in the region,
uncovering some countries’ initiatives aimed at bringing their regulatory processes in line with
traditional markets in the west
I
n recent years, clinical research activity has FDA audit results and they conduct a large higher enrolment rates (see Table 2). Patient
seen a huge shift towards the emerging number of trials each year – so they clearly retention is also very good in Latin America,
markets of Asia-Pacifi c, Central and Eastern can be considered the region’s “emerged” which is vital for the sustainability of trials. This
Europe and Latin America. In 2007, 42% of markets. is largely down to good patient/investigator
patients taking part in clinical trials worldwide Meanwhile, the region’s up and coming relations, she adds.
were from emerging economies, more than markets – in effect, its very own “emerging”
double the fi gure in 2002, estimates Dr Dennis economies – include Chile, Colombia and
the cost advantage
Hurley, vice-president of Kendle’s operations Peru. “They are attracting more and more
Emerging regions, Latin America included, offer
in Latin America. And approximately 10% of FDA inspections and the results are good.
a cost advantage compared with traditional
these patients were from Latin America, he They are therefore gaining recognition,” says
markets, a key consideration given the rising
says. Dr Hurley.
costs of pharmaceutical R&D. Developing a new
Graciela Racaro, Parexel’s senior director of
drug all the way to market now takes 10-15
clinical operations in Latin America adds: “Five
emerging regions’ pros years and more than $1.2 billion of investment,
years ago sponsors came to Latin America
As in other emerging regions, the quality of according to the Tufts Center for the Study of
mainly for rescue studies [when sponsors
data generated throughout Latin America is Drug Development. Conducting a trial in Latin
include an emerging region to meet
good and it competes well with developed America costs about 70-80% of an equivalent
enrolment targets on time]. Now the region is
markets such as the US. study in the US or Western Europe, where
involved in planning from the very beginning.”
Since 2006, 5.4% of US-based clinical trials experience and expertise make clinical research
Approximately 1,500 trial sites are set up in
inspected by the country’s FDA have received more expensive. Added to this, “Latin America’s
Latin America each year, based on the number
notifications of official action indicated. “This pharmaceutical market is growing well, meaning
of US FDA 1572s filed (forms filed by
investigators if the product undergoing trial is
Table 2: Variation in global patient recruitment rates
to be marketed in the US), says Dr Hurley.
Region Average number of patients enrolled per site
“No one wants to go without Mexico, Brazil
or Argentina because they have the strong
Asia-Pacif_i c 5.78
researchers, key opinion leaders and they are
bigger markets,” he says.
South and Central America 4.56
These three countries are the most
Central and Eastern Europe 6.27
developed clinical trial markets in the region,
in terms of the number of active, completed
Western Europe 3.08
or recruiting studies listed on the US National
US 1.92
Institutes of Health’s
Clinicaltrials.gov database
(see Table 1). Mexico, Brazil and Argentina
Source: Lehman Brothers November 2007,
as published in Parexel’s Bio’Pharmaceutical R&D Statistical Sourcebook 2008/2009
have been active on the global clinical
research map for 15 years, they have excellent
means that around one in every 20 sites that there is strong sales potential for the
inspected in the US is considered by the FDA product after it is approved”, argues Ms Racaro.
Table 1: Clinicaltrials.gov-listed inspector as having serious problems,” Retail pharmacy sales in Argentina grew by 20%,
studies in Latin America
comments Dr Hurley. For trials conducted considerably outstripping growth in Europe
outside the US, this figure was just one in 187. (+3%) and the US (+1%). Argentina, Brazil and
Brazil 1,039
Moreover, of the 90 inspections carried out Mexico together generate around 80% of Latin
outside the US in 2007, 12 were conducted in America’s sales. Retail pharmacy sales in these
Mexico 845
Latin America and all received positive results. three countries totalled $24 billion in the 12
Argentina 738 This disparity perhaps arises because most months to July 2008 (see Table 3).
sponsors venturing into “non-traditional” Latin America also offers another unique
Chile 377
regions put a lot of emphasis on monitoring advantage: the common language of Spanish
Peru 366
and education. Investigators in emerging (except, of course, in Brazil where Portuguese is
regions are also eager to learn and to be spoken). This factor can save time, money and
Colombia 239
compliant. “They don’t take it for granted that HR requirements. “A CRA [clinical research
Costa Rica 92
they have an opportunity to take part in a associate] coming from Argentina can work in
clinical trial,” says Dr Hurley. Uruguay or Colombia and use the same
Guatemala 88 Ms Racaro of Parexel notes that, like the language, but in Western Europe a CRA going
Asia-Pacific region and Central and Eastern from France to Spain would need to speak two
Panama 65
Europe, Latin America promises a large languages”. The common language also reduces
Source:
Clinicaltrials.gov, October 2008
number of treatment naive patients as well as translation costs, says Ms Racaro.
92
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