Many industry key opinion leaders thought healthcare among other systems in Latin America did not meet U.S. and European standards. But today, the region is valued for its time and cost efficiencies, more accessible and compliant customers and patients, and also investigators that show themselves as competent and enthusiastic professionals, contributing to clinical research efficiency.
Regulatory activities may in some cases, depending on the country, take longer than U.S. and Europe, but sponsors achieve time savings when enrolling patients. Most of the Latin-American cities are densely populated which gives each site more patients, easier to follow-up, and less travel expenses for sponsors making it less expensive than going to Asia or Europe.
On the other hand, medical standards are high and investigators are aware of Good Clinical Practice. Also, investigators are eager to participate in clinical research and their commitment helps to ensure patient retention.
Time and Cost Efficiency
Sponsors group their biggest savings through efficient patient enrollment due to more patients per site, patients are more trusting, and there are less trials competing for the same subjects. Also, because the northern and southern hemispheres have opposite seasons, on seasonal diseases, year-round trials can be performed in Latin America in conjunction with studies in North America and/or Europe.
Accessible Patients
Race and ethnicity vary greatly from country to country but language is not a barrier. English is well spoken by professionals. (English is my second language)
Disease patterns resemble those of the U.S. and Europe. Deaths from infectious diseases are declining while cancer and heart disease mortality rates are rising.
Patients are self-motivated to participate and tend to comply with trial requirements because the structure and accessible care are valued.
Competent Investigators
Many investigators in the region have been trained in the U.S. or Europe and the commitment level is strong in site-related activities.
Challenges
Latin America, like any developing region, has its share of challenges.
• Importation can be daunting especially in countries with negative trade agreements
• Some sites lack good infrastructure
• Requirements for informed consent forms (ICFs) can be harsh
• Some studies raise issues at a cultural level – related to the Catholic religion
Sponsors and industry experts who invest time and resources in appropriate preparation discover that they can perform medical research with quality results more efficiently in Latin America.
Related Articles:
- How to boost Hispanics’participation in clinical trials? Relate to them, study shows
- Clinical Trials Diversity – More Minorities Needed to Make Research Relevant to All
- Clinical Research in Ecuador – Diversity in Hispanic Community Involvement
- 6 Reasons to diversify Clinical Trials