With so many cultures, populations, and regulatory variability in Latin America (LATAM), pinning it down to a specific cultural or business practice can be a more sophisticated process than it is in other regions. For clinical trials, Latin America is a hotbed of ethnic diversity, with Native, African, and European ethnicities who inhabit a diverse expanse of geography that stretches from the southern part of North America through to the bottom of South America, even including the famously-remote Easter Island. Where kindness, respect, and modesty go a long way anywhere in the world, this could be equally said to be the norm in LATAM culture. Beyond precision translations in Spanish and Portuguese, understanding of cultural communication norms and local governance variability are crucial to success.
“LATAM” has over 650 million people who speak predominantly two languages: Spanish (60%), and Portuguese (35%); the rest of whom speak an array of languages from French to Dutch to Mayan, Guarani, and more. While Argentina, Mexico, and Brazil have the highest concentration of clinical trials, Brazil is the clear leader with 43% of LATAM totals. Brazil’s clinical trial market is in fact so big that it sits solidly in Pfizer’s top 5 countries for patient inquiries – the others being Australia, USA, China, and Japan. Along with a pre-COVID projected average growth of 8.20% ($1.72B USD in 2019 to $2.55B USD in 2024), the LATAM Clinical Trials Market is a regional market to pay attention to even though it makes up only 6% of global clinical trials.
Beyond growth rates, there are important and unique implications when working in LATAM. Variance among national governments gives way to regulatory variability — for example where some countries require local labeling, others do not. In some countries the informed consent form (ICF) can be submitted in English, where in others, it cannot. Recruitment is famously fast and cheap in Latin America, making up for regulatory approval timeline variability which can range from just a few months to over a year.
Political and economic variability in LATAM may cause some to search elsewhere for clinical trial growth, but the emerging region has a reputation for high-quality, FDA surveilled research centers with comparatively low costs – just $2-4k per patient which is significantly less than in the US and EU.
With the Latin American community stretching from Patagonia in the southern hemisphere to Miami in the north, local trial data can be beneficial at a global level. For example, real-world evidence from patients in Mexico could further research on Latin American populations in the United States, and even have implications for medical research in Spain and Portugal, which have been hard-hit by COVID-19.
Cultural and geographic complexities notwithstanding, the continued boom of LATAM’s clinical trials draw medical researchers far and wide for example, ICON and IQVIA, who are all well-established in these communities. Looking for growth, they learn local operating customs with sensitivity to cultural communication practices, as well as an understanding of diversity in regulatory locales. This is made possible by qualified medical translators, who understand the global and local intricacies. Such an encouraging prospect reminds us of the meaningful opportunities to serve those who lie outside of the microscope’s main field of view. The diversity found in Latin America can be an inspiration to us all in widening research for more representative and inclusive data.
- Dr. Hope
About CSOFT Health Sciences
CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.
CSOFT International is a leading provider of cross-border communications for enterprises seeking growth in global markets. Our expertise in localization, documentation, and branding encompasses a full range of end-to-end content and consulting services that we deliver in over 250 languages. With a focus in health sciences and smart technology, we work closely with our clients to deliver precision solutions to the challenges of engaging markets, consumers, and regulatory environments worldwide.
Dr. Hope is not a doctor but a creative voice at CSOFT Health Sciences, who seeks to provide insightful, factual, and relevant explanations of phenomena in the medical industry. Sometimes historical, other times philosophical, and generally related to the scientific interest and well-being of society, Dr. Hope provides commentary, inspiration and hope to readers thinking about health in the big-picture. You should not rely on this information as a substitute for, nor does it replace, professional medical advice, diagnosis, or treatment.