Photography: Odilion Dimier, PhotoDisc, Getty Images Illustration: Paul A. Belci
|
Several countries in Central and Eastern Europe, Asia, and Latin America are among the most prominent new locations for outsourcing
clinical trials. In the past, few clinical trials were conducted in Latin America due to a number of factors including poverty,
political instability, and lack of infrastructure. Most importantly, however, regulatory requirements did not meet with international
standards. Recently, governments in this region have made considerable efforts to improve their health care regulations, including
the gradual implementation of ICH-GCP guidelines in clinical research.
Argentina currently has the most advanced regulatory legislation in Latin America.1 Another problem that is gradually being overcome is the lack of adequate patent protection in Latin America. Between 1991
and 1995, new patent protection laws were established in several Latin American countries, including Peru, Argentina, Mexico,
Chile, and Brazil.2 This has further facilitated the growth of clinical research and development in this region.
Despite the advantages of outsourcing clinical trials, language remains a major issue, even in Latin America, where one language
dominates. Spanish is officially the main language, with the exception of Portuguese in Brazil. This reduces the complications
that arise in regions where translation of regulatory documents must be done in multiple languages. The use of a common language
also reduces language barriers in conducting multinational clinical trials, particularly compared to other newly expanding
regions such as Eastern Europe and Asia.
However, the issue of language in Latin America should not be underestimated. For one thing, there are several regional differences
in the Spanish spoken. Furthermore, these differences among Latin American countries can introduce barriers to research if
they are not addressed.In addition, differences in cultural attitudes and medical practices must also be taken into account. While there are many
advantages to conducting studies in this region, successful clinical trial management requires that language and cultural
differences be taken into consideration.
Emerging reasons
Therapeutic Opportunities
|
Among emerging research markets, Latin America is becoming a desirable location for conducting clinical trials for a range
of reasons, mostly related to subject recruitment.
According to DataEdge,3 Latin America is the world's fourth largest clinical trials market. The concentration of the region's population of 500
million people in urban areas (where 70% of the total population lives) facilitates rapid subject enrollment. The four largest
cities in Latin America—Mexico City, Rio de Janeiro, Sao Paulo, and Buenos Aires—are among the largest cities in the world,
accounting for over 40 million people.
Due to such large numbers of drug-naïve subjects, their proximity to urban centers, the high success of subject enrollment
and retention, and reduced costs for clinical research, Latin America is understandably playing a growing role in global clinical
trials.
Mexico, Brazil, and Argentina are the three most established Latin American countries in clinical research due to improvements
in their regulatory legislation. Other countries in Latin America are evolving their health care-related legislation, and
thus regulatory environments are continually improving.
Currently, Argentina, Brazil, Mexico, Chile, Colombia, and Peru are the primary Latin American countries conducting clinical
trials. This is in large part due to the fact that their combined populations account for approximately 80% of the region's
total population,4 greatly facilitating their ability to meet subject enrollment requirements. The importance of these large populations in
recruiting subjects for multinational, multicenter trials, which are increasingly common particularly in Phase III, reflects
the expansion of clinical trials in the area over the last decade.
The primary reason that recruited subjects in Latin America are more eager to enroll in clinical trials is that for much of
the population no other treatment options are available. Due to the fact that many trial subjects come from lower economic
backgrounds, they do not have the resources or access to current and effective medical therapies available in more developed
parts of the world. Thus, the ability to participate in a clinical study may be the only opportunity to receive treatment
for their particular ailment, and following regulatory approval, such therapies may become more readily available.
In addition, the number of qualified clinical investigators is increasing to meet the growing demand in clinical research
in the region. The advantages of conducting clinical research in Latin America are clear, however, there are important barriers
that must be overcome.
