Running clinical trials in Latin America (LatAm) has been a controversial topic over the past 15 years. This region is considered as an emerging market with a large and diverse population, medical experience, alongside opportunities for drug commercialization and sales. This is still a region with room for improvement in terms of regulations, consistency and timelines among others – the big questions for enterprises could be… Should I stay or should I go?
Clinical research in this region has been growing steadily, so regulations and interactions have been developing in parallel, keeping an expected difference in population, politics, processes and disease prevalence within LatAm countries. Nevertheless, we are in the network age and we must complement each other in order to move forward.
Despite the fact that new regulations are coming in each year for every country and there are changes in politics alongside governmental policy, LatAm is still an attractive region for stakeholders to run clinical trials.
We always hear about the advantages of LatAm-run trials, such as; large patient populations across 20 countries, qualified investigators, established regulatory frameworks, excellent clinical professionals with credible scientific backgrounds and reasonable costs, so large multinational pharmaceutical companies have been establishing trials in LatAm Countries. However, we need to accept there is room for improvement and address noted issues (in which ethics and quality are the most important item) to become a competitive and a realistic consideration as a scientific region, So, let´s review improvement opportunities.
The number of clinical studies in the region has increased by around 200% in the last 7 years, however the number of scientific publications generated is still low and represents just 3.4% of worldwide publications (an increase of 1.4% over the last 10 years), while USA has 33% and European Countries and Japan around 10%. Latin American science is still below average, so impoved infrastructure, resources, policies and regulations are needed to put LatAm in the loop of clinical research. The region needs to increase its participation in early stages of research and 'promote' its investigators as international leaders, contributing to protocol development and conducting clinical trials on a global scale. The region has plenty of highly educated researchers with an appetite of science and recognition, which needs to be capitalized on.
Regarding quality; Argentina, Brazil and Mexico have undergone approximately 20 FDA inspections and 95% of the findings were under no action required. The FDA are not just involved with inspections and data quality;regulatory agencies are now running more and more inspections, with transparent and clear results, that are focused on patient safety and data quality. This is a perfect example to show how authorities are now more interested in promoting patient rights and quality. There are also inspections to ensure that ethics committee members are independent of the administration of the institutions in which they are based and must include experts in clinical research and in bioethics, but unfortunately this is not always the case.
Clinical trials are a response to a medical necessity, providing innovative treatments to diseases. These are conducted under strict and harmonized rules, so as a general assumption we can state that clinical trials and the rules for conducting them are the same worldwide. So, why still we have big differences between countries and regions?
In theory, a country cannot perform clinical research until strong processes and regulations are in place. In the absence of a proper policy by the country authorities, the liability is on study sponsors and investigators to decide which studies can be conducted in that country, what limitations should be placed on them, and what oversight should be provided.
Many sectors are working to build up Latin America's infrastructure and the pharmaceutical industry is taking the lead in pushing this acceleration, by clarifying grey areas in regulations and encouraging faster timeframes.
The translation process is simplified in the LatAm region, as we need just two languages (Spanish and Portuguese) to cover around 20 countries. These countries have a growing pharmaceutical market, between 10% and 16% in the last two years. This is reflected in new drug submissions, across 25% of FDA and 31% of EMEA submissions are now collected from countries outside the USA and EU. There are doubts, globally, about patients from countries with low and mid-education levels participating in clinical trials; protecting their rights is probably the first item in which different parties have been focused with. Ethics committees, regulatory authorities, the pharmaceutical industry, professional associations and clinical researchers have been working to change this image about patient rights and quality in those Countries.
Historical data can show some failures in quality or protection of patients, however if we dig into other countries or regions we can find the same concerns. Regulations to protect human rights are in place in the most developed LatAm countries and standard for clinical research is high compared with Europe and USA despite the fact about costs. This is not the only reason why LatAm is attractive, but a naïve population, a well established regulatory framework and experienced clinical researchers all contribute to attracting more trials in this region.
Regarding regulatory issues, the main countries have regulations in place for clinical trials, but sometimes established timelines are not strictly followed. We are required to include the first patient into the study on average 6 months after clinical study protocol release.
This tends not to be an issue, of course there are some studies with very short timelines in which LatAm cannot participate, but the bottom line is inconsistency and credibility so while regulatory timelines as still considerably long, this is often compensated by the faster recruitment rate.
I mentioned before the age of networking, and this needs to be taken advantage of. We need to build alliances with Academies, Universities, Public institutions and international agencies to create awareness and visibility and of course, to have updated databases and reliable data about prevalence and incidence.
Clinical trials are attractive for many parties: patients, to have access to innovation, physicians, to participate in research and be involved in the latest innovation and drug development, and for the industry, to have high data quality in place and in time and to obtain return of investment, but also for the government, to attract investment and innovation.
Of course there is still a lot to do in this region, such as strengthening our regulatory framework and timelines, ensuring all ethics parties are working according to the highest standards and ensuring patient rights. However I truly think to invest in clinical trials in LatAm is a wise decision, and thanks to that investment we can save lives, improve patients health and of course have an incredibly positive effect on our economy.
I am convinced LatAm is a region full of passion, experience and highly educated people interested in science and people and should be an avenue all companies are exploring.
5. Hofstede, Geert, Cultures & Organizations, Software of the Mind, McGraw-Hill , May 3, 2010.
7. Hermes-Lima M, Santos NCF, Alencastro ACR, Ferreira ST (2007) Whither Latin America? Trends and Challenges of Science in Latin America. IUBMB Life 594-5:199-210 [PubMed] 8. Centerwatch