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Clinical Trials in Latin America
Latin America: A Region of Diversity, a World of Opportunity for Clinical Trial Sponsors
Latin America is hardly the latest new region to be discovered for conducting pharmaceutical clinical trials; global pharmaceutical companies have been running clinical trials in Latin America for over 20 years. Nonetheless, the region is noteworthy because it is still an attractive location for clinical research— and in many ways more conducive to studies than ever before.
The more than 20 countries that make up Latin America offer a vast pool of subjects for trials and patients for marketed drugs. Approximately 600 million people live in the region, which stretches from Mexico in the North to Chile and Argentina in the South. Indeed, the combined populations of just three countries, Brazil (192 million), Mexico (103 million), and Argentina (41 million), surpass the U.S. population. Sponsor companies that are sensitive to the differences in demographics and regulations from one country to the next will find that Latin America is ripe with opportunities for clinical research.
The benefits—most especially easy access a diverse patient population—outweigh the challenges of obtaining regulatory approval. This article highlights some of the characteristics of Latin America as a whole that are relevant for companies interested in launching studies in the region. While detailed country-specific information is required to determine which countries would be most appropriate for any given study, this overview serves as a good foundation on which to build a deeper exploration.
THE WORLD’S MOST ETHNICALLY DIVERSE REGION
The countries that comprise Latin America all share a Latin ancestral influence and speak either Spanish or Portuguese. The region, which covers roughly 13 million square miles, is one of the most ethnically diverse on the planet.
Within Latin America, there are Native Americans or Amerindians, the region’s indigenous people; Blacks; Mulattos; Mestizos (those of mixed European and Amerindian ancestry); and Caucasians, although the composition varies from country to country. Native Americans represent 8% of the overall population, but represent a majority in Bolivia and constitute sizeable minorities in Ecuador, Guatemala, and Peru. Caucasians predominate in Argentina, Uruguay, and Puerto Rico. Brazil is made up of a high percentage of mixed Black and Caucasian (or Mulatto) people. The remaining countries have high, but varying, percentages of Native Americans, and mixed races. Consequently, the culture of each country is quite unique.
POPULATION MAKEUP (%) IN KEY LATIN AMERICAN COUNTRIES
This racial diversity is an important factor to consider in country/site selection for studies in which the incidence of disease is significantly higher in a particular group. The region has experienced the same phenomenon as the rest of the world in terms of an increase in life expectancy. Thanks to improved sanitation, public health programs, better nutrition, economic development and medical advances (particularly those that significantly reduced infant mortality), Latin Americans are living longer, and the elderly portion of the population is increasing.
The Population Reference Bureau reports that those 65 and older already represent 10% of Argentina, Cuba, and Uruguay, and this will be the case in most Latin American countries by 2030.1 As in other areas of the world, there has also been an epidemiological transition: the prevalence and incidence of communicable diseases have been decreasing while the prevalence and incidence of “lifestyle” disease have been rising at an alarming rate. Urbanization, a sedentary lifestyle, smoking, and a diet rich in fats and carbohydrates is contributing to cardiovascular disease, obesity, diabetes mellitus and chronic kidney disease. Thus, Latin America’s pattern of disease is beginning to mirror that of the U.S. and EU countries.
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