As the largest country in Latin America, Brazil offers excellent potential for conducting clinical trials across a broad range of therapeutic indications and patient populations. With our recent acquisition of IC-Research, Kendle now offers coverage across more Latin American countries than any other global CRO, with seven offices in six countries representing 80 percent of the region’s population.
Total revenues from prescription drugs in Brazil totaled $5.4 billion in 2003. However, many diseases that have been eradicated in the United States and Europe still exist in Brazil, and many serious illnesses go untreated. Cardiovascular disease is the number one cause of death and there is also a high morbidity related to oncology. HIV programs, on the other hand, are standardized and supported by the Ministry of Health.
Alongside many countries in Latin America, Brazil offers exceptional scope for pediatric trials, with a significant proportion of the population (25.8 percent) 14 years or younger. Reverse seasons (it is summer in Brazil when it is winter in the United States) allow companies to test drugs for seasonally-induced diseases year-round by including Brazil and other southern hemisphere countries where Kendle has operations.
Brazil has a well-established regulatory process based on ICH GCP, and process approval time usually takes from 28 to 32 weeks. Regulatory authorities include the Institutional Ethics Committee (CEP), the National Ethics Committee (CONEP) and the Ministry of Health (ANVISA). The United States Food and Drug Administration has been inspecting clinical trials conducted in Brazil since 1996, all with positive results. The country has increased its clinical research activity considerably over the past years and approximately two thirds of the trials performed are Phase III.
Large Japanese population Brazil has the largest concentration of ethnic Japanese living outside of Japan. This is significant because Japan is the second largest consumer of pharmaceutical products in the world and it is difficult to enroll patients there because of the high number of competing trials. However, the adoption of the International Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data allows Japan’s drug approval authorities to accept data from studies that include ethnic Japanese living outside of Japan.
