Global Shifts in Early-Phase Clinical Studies: Is Latin America the Answer?

Traditionally, early-phase clinical studies are often conducted in the US and Europe. However, several emerging challenges are driving the need to explore new locations for these studies:

• Increasing Study Volume: A surge in biotech investments has led to intense demand for early-phase study sites, pressuring current availability.
• Challenges in Recruitment: As the focus shifts to rare diseases and precision medicine, finding suitable subjects who meet strict inclusion criteria has become increasingly challenging.
• Demand for Diversity: To meet regulatory and scientific requirements, clinical studies are now expected to include diverse populations—an area where traditional markets often fall short.

The Rise of Australia—and Its Limitations

In recent years, Australia has become a prominent choice for early-phase studies due to government incentives, streamlined regulatory processes, and competitive costs. This growth has positioned Australia as the third-largest site for Phase I studies globally. Yet, with success has come new obstacles: the high demand has strained administrative resources, causing delays in study initiation. Additionally, Australia’s relatively homogenous population presents limitations for studies that require diverse patient cohorts.

A Promising Alternative: Latin America

With these challenges in mind, Latin America emerges as a compelling alternative for early-phase clinical trials. Here’s why this region holds untapped potential:

1. Cost Efficiency: Latin America offers lower operational costs for site fees, recruitment, and labor, all while upholding the rigorous standards required for high-quality research.
2. Diverse Patient Populations: The region’s genetic diversity provides an opportunity for trials that require a wide range of genetic subtypes—critical for studies targeting diverse or underserved populations.
3. Rapid Recruitment and High Retention: Latin America has a large population of treatment-naive patients, resulting in faster recruitment timelines than in the US or Europe. The scarcity of accessible treatments in the region also incentivizes patients to remain in studies, improving retention rates.
4. Government and Regulatory Support: Countries like Brazil, Argentina, Mexico, Chile, and Colombia are heavily investing in clinical research infrastructure and are committed to expediting regulatory processes. For instance, regulatory agencies such as COFEPRIS (Mexico) and ANVISA (Brazil) are dedicated to high ethical standards, which ensure data integrity and patient safety. Mexico and Argentina have notably reduced clinical trial approval times, further accelerating study initiation.
5. Access to Emerging Markets: Conducting early-phase studies in Latin America not only enables data collection from a diverse cohort but also provides early access to rapidly growing economies—offering a strategic advantage for companies aiming to expand globally.

A Compelling Opportunity for Biopharma

By leveraging the benefits of cost efficiency, genetic diversity, rapid patient recruitment, and robust regulatory support in Latin America, early-phase clinical studies can be conducted faster and more affordably while producing high-quality data that meets FDA standards. These factors make Latin America a strategic choice for biopharma companies looking to navigate the complexities of early-phase research and address the diversity gaps that traditional markets often face.

Are you looking to accelerate your early-phase clinical trial while addressing challenges like diversity, recruitment, and cost efficiency? Let’s discuss how Farmacon Global can help you tap into Latin America’s potential with our strategic trial design and execution expertise. Reach out today to ensure your study achieves faster enrollment, diverse patient representation, and high-quality outcomes while staying ahead of regulatory requirements and market opportunities.

This article was originally drafted by Dr. Colin Scott, a valued member of Farmacon Global's Advisory Board. As a senior pharmaceutical industry executive, Dr. Scott brings a wealth of experience in global strategic pre-clinical, clinical, and regulatory development. Specializing in rare diseases and regulatory submissions, Dr. Scott has overseen the submission of numerous NDAs, MAAs, INDs, and CTAs. His work spans across North America, Europe, Asia, Latin America, and beyond, and he is recognized for optimizing product commercialization and regulatory pathways for small molecules, biologics, and medical devices.