Latin America holds great promise for clinical trials – and for attaining the diversity goals increasingly mandated by regulatory bodies. At the same time, the region’s sheer size and diversity, along with a mix of different economies, populations, languages, and rapidly evolving regulatory policies, present significant challenges. To help navigate this complex landscape, we have brought together a panel of life sciences experts representing several key Latin American countries in this iteration of Vistatec’s “Life Sciences – In Focus” series. Following a high-level overview of the regulatory and clinical trial landscape, its challenges, and inherent opportunities by Farmacon Global CEO Sara Tylosky, Vistatec’s María Mateos led a discussion to elicit key insights to help viewers develop successful strategies for conducting clinical trials in the region while managing risks and ensuring compliance.
The Participants
Host
- María Mateos, Strategic Account Director – Life Sciences, Vistatec
Special Guest/Presenter
- Sara Tylosky, MBA – CEO, Farmacon Global
Panelists
- Juana Tobos, Senior Regulatory and Logistics Analyst, Intrials (Colombia)
- Julián Orta Sosa, Sr. Regulatory Affairs Specialist, Worldwide Clinical Trials (Argentina)
- Dr. Charles Schmidt, Senior Medical Advisor, Tigermed (Brazil)
Latin America and its regulatory landscape
With a total population of more than 650 million spread across 33 countries in Central America, South America, and the Caribbean, Latin America’s complexity cannot be overstated. In addition, while Spanish and Brazilian Portuguese are predominant, 560 languages are spoken throughout the region.
Key LATAM Countries and their predominant language
- Brazil (Brazilian Portugese)
- Mexico (Spanish)
- Colombia (Spanish)
- Argentina (Spanish)
70% of the region’s population lives in Brazil, Mexico, and Colombia. These countries are highly diverse, with various ethnic groups, including indigenous peoples and descendants of Africans and European and Asian immigrants. Due to factors such as aging and rapid urbanization, the demographics of these countries are rapidly changing, with tremendous potential for economic and social development.
Nevertheless, Latin America lags far behind the US and Europe in terms of the share of worldwide clinical trials, although key prerequisites for clinical trials are in place, such as:
- Compliance with GCP and ICH guidelines
- Modern facilities
- Well-trained professionals
Regulatory Timelines for Clinical Trials in Latin America
While timelines in the US and Europe are short, enrollment is low. Whereas timelines in Latin America tend to be slightly longer, enrollment is significantly higher, and the dropout rate is 50% lower. In addition, typical timelines are not as long as many believe:
Argentina – 60-90 days
Brazil – ≤ 90 days
Colombia – 60-90 days
Navigating the Regulatory Landscape by Country
Brazil
- Early engagement with both ANVISA and INEP and pre-submission meetings are vital.
- Comprehensive, guideline-compliant dossiers must be submitted.
- Efficient, clear communication is necessary – local representation and local experts can help.
- Well-trained staff and a good understanding of regulatory requirements are crucial.
- Law 14.874/24 will soon take effect, making Brazil one of the few countries with a law rather than simply a regulatory process. This streamlines the assessment process, reduces bureaucratic obstacles, improves assessment predictability, and shortens timelines. It requires ANVISA to respond to all clinical trial applications within 90 days.
- A significant increase in clinical trials is expected in the years to come, especially due to ANVISA’s close connection with the FDA.
- Currently, 900 IRBs are operational.
Mexico
- Must engage with COFEPRIS and the local research ethics commission (REC) early in the planning process to understand requirements and address issues.
- Complete and accurate documentation is vital.
- Local regulatory experts can help navigate the regulatory landscape and assist with efficient communication.
- Investment in training and capacity building for local investigators is vital.
- Regulatory changes and evolving requirements necessitate flexible strategies and adaptability.
Argentina
- Argentina has a nimble regulatory agency and well-trained physicians, making it ideal for clinical trials.
- Online submissions are fast, and timelines have been greatly improved.
- Preview meetings with MOH are possible for complex study designs or vulnerable populations.
- Problematic: Regions and provinces have their own MOH, but once approval is complete, evaluation happens rapidly.
- Prepare for regulatory inspections by keeping accurate, thorough records, training staff, and conducting internal audits.
- Argentina’s geographical diversity provides a diverse population and disease patterns for analysis.
Colombia
- While the regulatory process is more bureaucratic, the electronic system is excellent, and there is robust legislation.
- Communication with health authorities is open, which is excellent for protocols with alternative or complex designs, etc.
- Site quality is high due to the INVIMA certification requirement, leading to high-quality results.
- Pre-submission is required; protocols should not be submitted before actual submission.
- Since Colombia has two coasts and a mountain range, different high-quality sites can study various populations. In addition, tropical areas and urbanization provide an interesting context for tropical disease research (dengue, malaria, etc.).
Additional takeaways
- Latin America is ideal for studying infectious diseases, such as dengue and malaria, and neglected and rare disease trials.
- Latin America’s aging population provides additional opportunities.
- Engaging with PIs is key when looking for sites in Latin America.
- Local health authorities are highly interested in health economics due to universal healthcare.
Rare Disease Research in Latin America
Following the discussion of the regulatory environments, host María Mateos specifically asked about rare disease research in Latin America. While the data is incomplete, in Brazil, up to 13 million patients are believed to have 7000-8000 rare diseases. The country also has newborn screening for hereditary metabolic disorders and significant data from 50 years. For its part, Argentina has seen a tremendous increase in rare disease studies. As a rule, PIs in Argentina welcome the opportunity to participate in such studies as much as families do. From a US perspective, the orphan drug designation law has allowed rare disease products to market more quickly, driving the development of such products worldwide.
As opposed to the US, patient advocacy groups for rare diseases are not yet common, and these do not have a history of pushing for specific trials to be conducted. Although such associations are becoming more prevalent culturally, it is important to connect with doctors. Additionally, in some larger Latin American countries, physicians with a small number of patients may be interested in being published, which makes it important to seek to connect with these providers. Several panelists noted that a large-scale website had been deployed to enable patients to find sites near them across Latin America, both in Spanish and Portuguese. Ms. Tuolsky noted that in some LatAm countries, endogamy (intermarriage between cousins) is not uncommon, creating a scenario where certain rare diseases may be more prevalent in some geographies.
The scientific community and conferences focus primarily on the US and Europe. Since rare diseases occur worldwide, it would be advisable to include LatAm, Asia, and Africa in the conversation. In Latin America, this can be complicated by legislation relating to trial participant reimbursement and patient benefits that impact both ethical considerations and cost. Thus, in certain countries, sponsors must continue to provide medication to patients who benefit from that medication during a trial for a certain period after the study.
Audience Questions
After such a fruitful and wide-ranging discussion, audience members had a chance to ask their most pressing questions. Naturally, AI was a key topic, as were language and diversity.
Language Requirements
Given the many languages and language variants spoken in Latin American countries, the languages and language variants used in clinical documentation must be specific to the country and the population. In addition, patient-facing content must be clear and suited to the level of health literacy and the language variant spoken. Thus, terms and phrases may differ between regional variants of Spanish spoken in Colombia, Mexico, and Argentina and must be used appropriately to ensure effective communication and participant engagement. Similarly, protocols and patient-facing documents created for the Portuguese market will require revision or retranslation in Brazil.
AI Regulation
With AI on everyone’s mind, panelists agreed that although the technology seemed promising, it needed to be used judiciously, especially in light of compliance with strict data protection laws in Latin America. Panelists acknowledged AI’s potential usefulness in prequalifying patients and preparing documents, but concerns about ethics and data collection remained. While AI may help streamline certain processes and tasks, such as the development of documents, consent forms, and regulatory submissions, physicians must continue to serve as “gateways” to patients.
Diversity and FDA Guidance
In light of the recent release of the FDA’s new draft guidance, participants were particularly interested in clinical trial diversity. The panel explored whether regulatory frameworks in Latin America enhance trial diversity and how clinical research organizations (CROs) and sponsors can ensure the representation of underrepresented populations. Given the social disparities present in Latin America, an equity and social justice-based approach is necessary. Steps such as ensuring diversity when selecting PIs and choosing sites in various socioeconomic areas can be helpful. However, whether the diversity mandated by the FDA in late-phase clinical trials can be achieved by enrolling participants in Latin America is unclear.
Engaging Latin America
Throughout the hour-long discussion, it became abundantly clear that careful consideration of linguistic conventions, cultural norms, and sensibilities is indispensable when successfully conducting clinical trials across Latin America. This is particularly crucial when the goal is to advance diversity, a topic discussed during the next Vistatec webinar on the FDA’s 2024 draft guidance on diversity. Throughout Latin America, social justice and health equity are also part of the equation. And, given the rapidly evolving and diverse regulatory and political landscape, it is no surprise that sponsors and other stakeholders are well advised to stay informed about such developments and their implications for research.
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Find the full event recording here, and watch this space for the next episode in our Life Sciences – In Focus series.