Latin America's Trials Climate

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.