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April 18, 2016
Latin America has long been on the radar as one of the emerging regions of the world and it is now no longer the new-kid on the block when it comes to conducting pharmaceutical clinical trials on its soil. Although over the last 20 years, some of the largest pharmaceutical companies have been running clinical trials in Latin America the market remains far from saturated as it continues to develop as a clinical trial destination. With a strong regulatory framework and clinical infrastructure in place to support the clinical trial research, Latin America is reaching its prime in terms of becoming one of the most sought after locations to perform clinical trials.
Home to around 600 million people, almost 9% of the world’s population live in the 20 countries that make up Latin America. The region is filled with clinical research opportunities with the benefits of such a diverse population heavily outweighing the difficulties of obtaining regulatory approval. As one of the most ethnically rich regions in the world, the culture of each country is unique in its own right. This racial diversity makes selecting the site or country to perform a clinical trial extremely important. With the rise of Latin America’s middle-class, improvements in sanitation, health and lifestyle, Latin America’s disease pattern has shifted to mirror that of Europe and the United States. The region is currently suffering from a significant rise in cases of diabetes, obesity and other lifestyle diseases similar to those found in more economically developed countries. With such a large and broad pool of patients, it becomes relatively easy to find patients that meet a certain criteria and those suffering from rarer conditions.
The number of qualified clinical investigators is growing across the region in order to meet the demand set by the amount of clinical research taking place in the region. Latin America has a long history of Western medicine and many of the region’s leading physicians have some form of training or experience in Europe or the United States. As a result of this, knowledge of the International Conference on Harmonisation (ICH) guidelines and awareness of the Good Clinical Practice (GCP) standards are widespread. On top of having a high standard of medical training in the region, many of Latin America’s investigators are eager to participate in research which also helps to ensure patient retention in the clinical trials. Much of their eagerness to participate in clinical trials comes down to being able to offer medical advances to their patients and as much of Latin America looks towards their North American neighbours, it also offers an amount of professional prestige. To make sure the clinical trials and sites adhere to the same standards as expected in the United States and Europe, they are often subjected to audits and inspections by bodies such as the US Food and Drug Administration (FDA).
Latin America’s trial market is perhaps the healthiest it has ever been. With the availability of highly qualified clinical investigators, improvement in facilities and quality standards across the board as well as a diverse pool of patients there is no better time than the present to conduct a clinical trial in Latin America. Given the size of Brazil and its pharmaceutical market, it is perhaps not surprising that it accounts for nearly one-third of all trials in the region. Despite Brazil’s active market, the region is far from saturated and is therefore at an ideal stage to carry out clinical trials. The accessibility of conducting trials in Latin America is perhaps its biggest draw as this ultimately translates into cost savings for the company performing the clinical trial. It is important to keep in mind that although the clinical community in Latin America is normally fluent in English, the study materials must be produced in the local language; either Spanish or Portuguese. Even though it may seem that there are only two basic languages to accommodate in the region, special care and attention must be paid to accommodate local nuances from one Latin American country to the next, especially where consent forms for patients are concerned.
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