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Clinical Trials in Latin America – Challenges and Opportunities

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Clinical Trials in Latin America – Challenges and Opportunities

Latin America has become a great ally for clinicians when developing Clinical Trials. This region provides many advantages and facilities other regions just can’t match.

With over 20 countries spaning from Mexico in North America to Chile and Argentina in the South.  Approximately 600 million people inhabit Latin America. 

Sponsors should be aware of the great advantages this region has to offer. Advantages that helps medicine reach FDA for approval faster than any other region. The reason for that is called: Diversity.


Why Latin America?

Number of clinical trials per country

According to there are over 16 thousands studies in Latin America. Most of them conducted in Brazil, Mexico, Colombia and Argentina. Latin America is one of the unexplored regions for Clinical Trials. The region only has about 6% of the total Active Studies in the world and about 11% of total studies according to the website

Number of Clinical Studies per Country

clinical trials in latin america opportunities challengesSource:
Elaborated by: FOMAT Marketing Department

About Hispanics in Clinical Trials

According to there are only 60 open trials focused only on Hispanics and 42 from those clinical trials are in the United States. That represents only 0.21% of the clinical trials that are open in the United States. Meaning that Hispanics are greatly underrepresented un clinical trials research in both domestic and worldwide regions.

A 2011conference report, “Dialogues on Diversifying Clinical Trials,” sponsored by FDA’s Office of Women’ s Health and the Society for Women’s Health Research and supported by the Office of Minority Health:

“Hispanics make up 16% of the (US) population but only 1% of clinical trial participants.”

Other sources confirm that Hispanics are underrepresented in clinical trials. The following data comes from a report presented by the NIH in 2013. This report shows the percentage of people enrolled in domestic NIH clinical research and compares it to the information from the US Census Data.

Minority Groups Underrepresentation in NIH Clinical Research

clinical trials latin america opportunities challenges


Latin America offers many opportunities for clinicians. You can review those opportunities in our Free White paper:  “Why You Should Run Clinical Trials in Latin America? – Challenges and Opportunities.” 


  • A year round Research – Don’t stop your trials because of weather conditions, lack of sites or participants. Discover how Latin America can help you continue you research.
  • Proven Quality for Research – Clinical Research Sites in Latin America are well conditioned and available. FDA approves them.
  • Strong patient/physician bond – Trust is an important issue when enrolling patients for clinical trials. Latin American physicians are truly respected and trusted. Learn how.
  • Diverse population – Latin America is the most diverse region in the world. People from all over the world gathers to enjoy its greatness. Diversify your clinical trials data in key countries.
  • A dense population – Easy access to patients – Urban areas in Latin America are very dense. Hospitals outpatients is off charts.
  • Substantial market for sales – Latin America represents over 10% of pharmaceuticals market sales. And that share is growing.


  • Time – Regulatory times may vary from country to country. Discover which countries have the shortest regulatory times in Latin America.
  • Culture – Different countries mean different cultures. Learn how accurately manage your clinical trial in key countries.
  • Cost – A common though is that Latin America clinical trials’ costs are nothing compared to U.S. – Learn more on how to overcome this problem.



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