Life-sciences companies have been conducting clinical trials in Latin America for more than 20 years, and interest in conducting clinical trials in the region continues to grow.
There are many advantages of conducting clinical trials in Latin America including:
1) Ability to conduct year-round research–Latin America is in the southern hemisphere, so the seasons are the inverse of the northern hemisphere. This allows studies on conditions tied to the seasons (ie, flu, seasonal allergies, and pneumonia) to proceed throughout the year.
2) A diverse patient population–There are approximately 600 million people living in Latin America, which has a wide variety of races and ethnicities. These include:
- Native Americans
- Amerindians (the region’s indigenous people)
- Mestizos (those of mixed European and Amerindian ancestry)
3) Qualified investigator community–Physicians in Latin America are well-trained and individual countries in Latin America have made significant investments in improving and expanding healthcare for their citizens. Additionally, all Latin American countries have adopted the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
4) Patient engagement and accessibility–Latin America has many dense urban areas with well-developed healthcare systems and investigator communities.Physicians and patients in these areas have strong bonds that result in high rates of patient compliance and study retention. Additionally, there are only two languages–Spanish and Portuguese–throughout the Latin America region, which reduces the need to translate and produce materials in multiple languages.
5) Proven quality–Audits performed by regulatory agencies, including the US Food and Drug Administration, confirm that quality standards are high for clinical trials conducted in Latin America.
6) Close proximity to North America–Latin America is close to corporate headquarters and research & development centers for many life sciences companies located in North America.
While there are many advantages to conducting clinical trials in Latin America, there are a few challenges as well. The primary challenge is the diversity in regulatory pathways for clinical studies and product approvals. Currently, each country has their own regulatory process; however, there are efforts to standardize regulatory approval pathways.
Additional challenges to be aware of in conducting clinical trials in Latin America include:
- Study budget and contract processes may take longer and require more face-to-face meetings than in the US and EU.
- Reimbursement codes for patient care must be well defined in the contract process with the clinical sites.
- Diagnostic tools and/or ancillary drugs and devices not reimbursed by local insurance payers may need to be covered by the Sponsor.
- For complex study protocols, there is a greater need for ongoing training at the site level.
- There are wide variances in education levels across the region, which need to be considered when preparing study materials.
In the next five years it is anticipated that there will be more standardization of local regulatory pathways for clinical trials and product approvals. Progress is being made in standardizing regulatory pathways with medical devices through The Pacific Alliance that includes Peru, Chile, Mexico, and Colombia. The Pacific Alliance is an economic program that supports regional integration with free movement of goods, services, resources, and people to further drive growth, development, and competitiveness of the economies of the member countries.
If you are considering conducting or expanding your clinical trials in Latin America, engage a partner that has experience in the region. Clinlogix has people and resources in the Latin American region with a strong background in GCP guidelines and with knowledge of local regulations to successfully execute an efficient regulatory and/or clinical project. We maintain long-term relationships with an important network of clinical sites; which helps speed up study enrolment. And, with the increase in combination products that include both a therapeutic “drug” and medical product, it’s beneficial to have a partner on your team that has extensive experience in both areas.
We’d love to hear from you! Please share your thoughts on and experiences in conducting clinical trials in Latin America.