Latin American in international clinical trials. Where is the difference? Is it in the patients, the physicians, or the system?

pp 6-15

Abstract

During the past 15 years, more than 15,000 Latin-American patients have been enrolled in international randomized clinical trials. However, few publications have discriminated patient characteristics, outcomes, and hospital practice patterns in Latin America. International comparisons can help to identify factors associated with higher risk in a given geographic region. In addition, race, ethnicity, and regional practice patterns can influence the treatment effect of a given therapy. We identified 3 reports from international clinical trials that have reported the outcomes of patients with acute coronary syndromes and practice patterns in Latin America. The results of these analyses are consistent, showing excessive morbidity and mortality, and a similar resource use in Latin America compared to other regions.

Further multivariate analyses have excluded patient baseline characteristics as responsible of the differences in the outcomes. It is plausible that the cause for the worse outcomes of Latin American patients with acute coronary syndromes is the result of many factors not included in the data forms of international trials. These factors include socioeconomic status, medical education, pressure from managed-care organizations, inverted physician-nurse proportion, medical errors, and others. Future studies collecting information on these factors could help to identify the actual causes for the excessive mortality in Latin America.