Bringing Initial Stages of Clinical Trials to Latin AmericaBy Miriam Bello | Thu, 12/24/2020 - 08:00
Q: Why is INTRIALS the best CRO partner for the healthcare industry?
A: INTRIALS has a local understanding of the region and each country’s differences, unlike other companies that see the region as a uniform entity. Even within the same country, there are regional differences. Moreover, to understand budgets and service coverage, it is important to have knowledge of Latin American society. For example, Brazil has programs to increase healthcare access while Peru continues to struggle on access.
There is a huge gap in clinical research in the region regarding the quality of doctors and the quantity of medical trials that are happening in the area. Latin America is a strong economy and has a very representative population. Yet, healthcare access is precarious. Clinical trials can contribute to closing this gap so it was very important to take our regional knowledge and expertise to the global stage to improve access to treatments and technology, while complementing the high quality of medical doctors and infrastructure in the region.
Q: What main advantages has the company gained by operating in Mexico?
A: Mexico is the one of the most important markets for INTRIALS. We have some of our strongest partnerships here and some of our largest clinical trials are running in the country. We see more opportunities in the future and we are hoping to become more competitive on a global scale. Mexico offers a mature market that is likely to develop quickly and we are prepared to capitalize on this.
The huge diversity of the Mexican population is valuable to our work and we are looking forward to continue communicating its value for trials globally. While this will benefit trial results, it will also grow treatment access in the country. Mexico has great cost-effective opportunities that we can still take advantage of to benefit both trials and patients.
Q: What have been INTRIALS’ main focus areas in Mexico?
A: Oncology, cardiovascular diseases and diabetes are enormous fields in the country. However, we have a strong focus on rare diseases and we are running clinical trials for these in Mexico. There are already many large pharmaceutical companies tackling research in those diseases and INTRIALS works with them. One of our goals is to introduce new therapies to the regional market, which is why we have strong connections with small and midsize biotech companies in the US, Europe and Asia. We try to introduce their developments to Brazil or Mexico by explaining the importance of running their clinical trials in the region at an earlier stage.
Q: What challenges has INTRIALS faced in recruiting local patients?
A: Mexico has an interesting dynamic in this sense. Depending on the part of the country where we want to focus, there can be a lack of proper infrastructure (laboratories or research centers) to provide the right diagnosis for a specific disease. To recruit patients, they also must have a strong relationship of trust with physicians. We have patients who are willing to participate but the infrastructure barriers makes it difficult. In Mexico, many people depend on the government for access to healthcare, which provides a more fruitful environment for recruiting and eventually improving the coverage of their services.
The COVID-19 vaccine development has definitely focused attention on clinical trials and its stages. This has, in a way, been useful in that we’ve been able to provide more information to the population about the importance of trials and also to push COFEPRIS to improve its regulatory framework for clinical trials. Having a strong regulatory authority is key because it enables us to be at the same level of worldwide developments and products.
Regulation in Latin America is always a challenge. For global trials, there are very efficient regulatory agencies like the FDA. While this is good for us to conduct top-quality trials, it can be a barrier because it means that we need to be as fast as other countries (US or Europe) when recruiting volunteers. Otherwise, we could miss the opportunity to participate.
INTRIALS, head-quartered in São Paulo, Brazil, offers CRO services, including project management, clinical trials monitoring, selection of study centers and management of regulatory affairs in Argentina, Chile, Colombia, Mexico and Peru