The process of conducting clinical trials in Latin America is still a relatively new trend – within the past 20 to 30 years. Less experienced investigators in some parts of the region might treat participation in clinical trials as more novel than counterparts in other countries where trials have been successfully managed for a longer period of time. Unfortunately, some media and organizations with little experience or knowledge appear to proliferate misconceptions that Latin America has lower standards for conducting trials.
In reality, those kinds of misconceptions couldn’t be further from the truth.
Latin American countries have actually become desirable sites for studies both because they’ve adopted regulations that mirror those recommended by the ICH/GCP and because the regulatory authorities are committed to keeping them updated. We have a very complex regulatory system for international trials due to stringent country regulations.
High-level quality standards and training programs have been developed in our region. Our cultural diversity and high patient enrollment rates with diverse disease presentations demand well-trained professionals throughout the trial structure (including sites, CROs, and sponsors.)
We are committed to building long-term professional relationships with our pharma sponsors. We find they prefer working directly with a digital CRO due, in part, to our quality of service and focus on trial success (timeline, budget, etc.) We receive great feedback on our qualified personnel, independent data analysis, professional behavior, and responsiveness – important (intangible) qualities when choosing a CRO with which to work.
So, as Latin America have become recognized for our enrollment potential and high quality of data, the number of clinical trials started in the three largest countries in the region has increased significantly over the past 5 years. According to data from clinicaltrial.gov, the number of clinical trials started in Brazil increased 58% in just a 4-year period (from 153 in 2005 to 241 in 2009.)
This is a trend I expect to see continue to increase exponentially over the next few years. Latin America, in particular, Brazil, is a hotbed of clinical trial activity and we’re proud to be a critical part of that success.
To learn more about challenges and solutions of conducting global trials in Latin America, read: