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International Clinical Trials
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Covering 20 countries and with a population of approximately 600
million, Latin America is one of the most ethnically diverse regions in
the world. The main causes of death in Latin America are explained by
sedentary habits, smoking and bad diets: ischemic heart disease,
cerebrovascular disease and diabetes mellitus are only some of the
results of these. However, due to recently enhanced sanitation
conditions, broader access to public health system, nutrition and the
reduction of infant mortality, the population as a whole is able to live
longer, and with a reasonable quality of life.
For clinical
research purposes, given the population dimension, it is easier to
select patients with certain circumstances – like untreated medical
conditions or rare diseases – when compared with North America and
Europe, contributing to the region’s attractiveness for clinical
research.
In 2020, the industry projects a market growth of 50%,
of which almost 20% will come from Latin America, especially Brazil,
Mexico and Argentina – the three main markets of medications’
purchasing. Given this fact, these are the most relevant markets in the
region regarding clinical research. Currently, there are more than 970
active interventional industry studies in the region, where the three
main markets – Brazil (363), Argentina (235) and Mexico (272) – are the
major contributors.
Patient Enrolment
Unique to
Latin America are two particular characteristics due to its geographic
and climate conditions: the occurrence of several tropical diseases –
such as dengue, Zika, malaria or Chagas disease – which are not found in
Europe or North America; and the season inversion between the Northern
and Southern hemispheres, which makes Latin America attractive for
immediate patient recruitment throughout the year. Sponsors can pursue
research on conditions that are tied to seasons – namely infectious
diseases, allergies or seasonal viruses – thereby improving market
access speed.
Furthermore, when clinical trials are conducted in
this region, the cost per patient is around 70% to 80% of the cost of
high-income countries. This translates to a possible 30% cost reduction
in the patient recruitment process.
Regulatory Landscape
Continuous
efforts have been made to harmonise approaches, where less regulated
countries in the region have started to follow the steps of Brazil,
Argentina and Mexico – today, all Latin American countries adhere to the
ICH and Good Clinical Practice guidelines.
The guidelines of
regulators may vary greatly, and it is necessary to comply with all the
given standard lines for each case. Local rules are different for trial
application and conduct. Normally, it requires the approval of the local
Ethic Committee and the Ministry of Health, and this can be somewhat of
a long process. Specifically in Brazil, recent regulatory changes aim
to reduce these timelines in clinical research. This new legislation
took into account the guidelines and processes from other international
authorities, such as the FDA and EMA, and set a new tone for clinical
research in Brazil. As a result, Brazil’s agency ANVISA takes an
important step towards making the country a more competitive market for
clinical research. This regulation establishes 90-day and 180-day
timelines for the analysis and approval of clinical research requests.
In
summary, by leveraging Latin America’s advantages – like patients’
recruitment and retention rates, high-quality professionals and the
governments’ awareness for clinical research – and considering the
challenges from the country’s heterogeneity, as well as having partners
with strong, local expertise, sponsors can achieve successful trials in
this region.
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