Addressing issues affecting clinical trials in Brazil

Abstract

There are several factors that play a key role in the growth of clinical research specific to Brazil. These include a large, diverse, rapidly growing population much of which is treatment-naive, shortened approval times, improved GCP compliance, and an emergence of diseases predominant in developed countries. Successful patient enrolment and retention rates, and proximity to Western biopharmaceutical companies are additional factors. Due to the fact that the Brazilian population exhibits great racial and ethnic diversity, as well as differences in economic and educational backgrounds, there are significant hurdles that foreign sponsors must consider. These include linguistic and cultural barriers, as well as other socio-economic factors such as poverty and illiteracy. Successful outsourcing of clinical trials to Brazil therefore involves an understanding of these factors, and how they affect clinical research.