Around the Globe: Latin America
Strategies to Achieve Greater Competitiveness for Clinical Trials in Latin America
Mariana Abdala
Crystal Research

linical trials in Latin America still face many challenges: Unstable regulations, bureaucratic complications, lack of adequate infrastructure, and an unending need to train researchers, physicians, and related research personnel show how much work remains to be done. Although quality levels and standards have noticeably improved, Latin America produces only about 3% of the world’s research, far behind Europe and Asia, which account for 25% and 29%, respectively. There is vast room for improvement.

Many European countries and the United States have a long and productive history of clinical research. Stable regulations and broad opportunities for clinical trials have helped develop a considerable number of research centers and large patient populations and databases. Although Europe has lost some competitive ground to Asia during the past decade, it still holds a leadership position in global clinical research, along with the United States and for similar reasons.

But certain aspects of Latin America are attractive for purposes of clinical research. For example, this region has broad ethnic (genetic) diversity; in addition, certain costs may be significantly lower and therefore more attractive for the pharmaceutical industry sponsors.

Getting Involved in Clinical Research: Experience and Education

The investments made by pharmaceutical companies to meet the rising demand for medicines increase the need for specialized, well-trained human resources to conduct clinical trials. This is not only an important opportunity to benefit patients, the regional community, and science; it is also an important driver to develop clinical research professionals and employment opportunities.

When I ask my students about their main interests, they express concern about where they could find employment as clinical trial coordinators or clinical monitors if they have no prior experience. They wonder how to gain such experience since many pharmaceutical companies seem to hire experienced personnel only. Difficulty with other languages and being prepared for audits are also concerns.

When considering these students and their desire to develop into professionals working for CROs or pharmaceutical companies, those of us who have been training personnel in clinical research centers for more than 20 years know that we were self-taught or were perhaps mentored by more experienced professionals. This happens primarily because in Latin America there are very few places where courses and workshops are available for learning these practices, or where training fellowships are available in research centers.

For all these reasons, it is extremely important that Latin American countries develop and offer more educational programs and forums, such as the ones provided by the Universidad Abierta Interamericana in Argentina; and by Crystal Research and the Universidad Peruana Cayetano Heredia, both in Peru. These provide workshops that disseminate current scientific and research information, plus channels for mentorship. Providing students with professional orientation and support, and helping them develop research competencies and skills, may give them further impetus to pursue professional development in the clinical research field.

Connection and Commitment

Being competitive at a regional level requires ongoing educational commitment. It is not enough to have adequate regulations and appropriate patient populations to attract more clinical trials to this region. It is also necessary to provide continuing education and training spaces for our future study coordinators, clinical monitors, researchers, nurses, regulatory assistants, and pharmaceutical industry professionals, among others.

I share my experiences with my students and explain what the world of clinical trials is about; I see delighted faces when the audience learns of the wide spectrum of opportunities for professional development and for earning a decent income. But even within the public health sector, a significant percentage still does not recognize these activities as an opportunity for career development.

In response, a blog created by a Spanish group of study coordinators at the time of the COVID-19 pandemic (“(DES)-coordinando un ensayo clínico” [“UN-coordinating a clinical trial”]) helps visualize in creative, dynamic, and amusing ways the roles and responsibilities of study coordinators and clinical monitors. Latin American experiences are incorporated, aiming to highlight recent discussions and experiences from this region.

Since education is power, imagine what we can accomplish if we continue to deliver lectures about clinical research in schools, universities, health centers, and similar institutions and audiences. We also would be able to bridge significant gaps in educational materials for patients.

Educating for Excellence

Connectivity allows us to reach distant places and different audience types, whether or not they are experts in this field.

Ongoing training and education are vital for optimizing the quality of clinical trials. There is no room for improvisation. Latin America has well-trained and experienced research centers but must develop a solid plan for training in this field. It is particularly important to train specialized personnel to enable proper decision making and proper actions in a timely manner, as was demonstrated in the different stages of vaccine development in response to the COVID-19 pandemic.

In this context, soft skills are extremely important, as are communication strategies. For example, it is necessary to increase the content written in Spanish for potential clinical trial participants in Latin America, because this is the language of most people in the region (except Brazil, of course). We must also develop digital applications and platforms that enable interaction with researchers, educators, students, and patients. We already know that educating, promoting, and informing communities about the available options for participating in clinical trials can increase voluntary participation.

Inclusion and Diversity: Latin America Calling!

Those of us who serve in the clinical trial world still have one pending task: to take concrete actions to increase the diversity of Latin American patients represented in clinical trials. It is quite clear that this is crucial for purposes of generating confidence and promoting equity in research to bridge the current gap in health equity. How? By generating more understanding among underserved communities about what a clinical trial is, explaining its potential benefits in simple language, assessing and overcoming difficulties, and facilitating access to clinical research. Following the communication efforts of Brazil and Columbia would greatly benefit other nations such as Argentina, Ecuador, Paraguay, and Peru. There is no doubt that increased diversity will improve the quality and credibility of clinical research.

Sometimes, patient mistrust towards physicians, institutions, and even scientific research may be a barrier. We must work to determine how these factors may influence patients when they make decisions about their health; moreover, it is important to spread appropriate information through social networks and other media so broader populations may be reached.

Improving trial access for patients will increase the efficiency and timeliness of clinical trials and promote Latin America as an attractive place for research. Regulatory agencies should simplify and standardize processes. Research institutions should update and offer continuous training on their procedures. Pharmaceutical companies should commit to continuous investment in the region. And clinical instructors and mentors must fulfill their educational mission and prepare their students to achieve excellence.