“Argentina has three major strengths when considering clinical research: it has the ANMAT[1], a pioneering entity that sets a solid regulatory framework for conducting high-quality research; it has excellent healthcare professionals and increasingly professionalized centers, and finally, amidst a health system in crisis, there is a significant increase in patients’ interest in participating in clinical trials, which allows them to receive excellent healthcare,” said Dr. Federico Pérez Manghi, a clinician specializing in Nutrition and Diabetes and president of theCINME (Center for Metabolic Research) in Buenos Aires.
Clinical research has grown exponentially both in Argentina and throughout Latin America. According to data from the Argentine associations that connect clinical research organizations and multinational pharmaceutical companies (CAOIC and CAEME), between 2017 and 2021, the number of clinical trials conducted in the country increased by 79%. The specific improvements established by ANMAT for the approval processes, the digitalization of paperwork, and the prestige of the medical community are the main reasons for this growth in the international participation of medical trials. Clinical research encompasses all activities aimed at determining the efficacy, safety and quality of drugs, treatments, detection, diagnosis and prevention mechanisms. This has a profound impact not only on patients and the health system as a whole but also on the country’s economy.
In Argentina, as in the rest of the region and other countries around the world, the 2020 pandemic was a before-and-after moment for clinical research. The urgent need for a COVID-19 vaccine promoted information and awareness about clinical trials.
“Before 2020, when I invited a patient to participate in a clinical trial, I had to explain to them what it was about and debunk many misconceptions. Today, this has changed. I like telling my patients that at the beginning of the 20th century, life expectancy was only 40 years. Now, thanks to clinical research and the advancements made, the global average life expectancy has doubled,” Dr.Pérez Manghi said.
Dr. Georgina Sposetti, an Argentinian clinician and diabetologist, agrees with him. She is the founder of Un ensayo para mí (A Trial for Me), an innovative platform in Latin America, that connects doctors, researchers, and patients in a safe, reliable and controlled environment. The goal is to promote information about ongoing clinical trials and ensure access to them.
“The growth was exponential after 2020. The vaccine trials during the pandemic helped a lot. From 2021 on, the platform has grown by about 120-150% each year. When we post a clinical trial for a disease, the number of patients who enter and ask is incredible,” Dr.Sposetti said.
Dr. Sposetti created the platform based on her personal experience. In 2013, she was diagnosed with Lewis-Sumner syndrome, a rare nervous system disorder for which there was no treatment available at the time. Her first impulse was to go online and volunteer for a clinical trial.
“During my own pursuit, I realized that for anyone lacking technical knowledge or English, having a rare disease or cancer and wanting to know about ongoing research was a real mission impossible,” Sposetti added.Un ensayo para mí (A Trial for Me) was recognized in 2021 as a pioneer in the region by The Lancet Oncology, and is now active in eight Latin American countries, serving as a space for direct communication with people and working to democratize information.
The profile of Latin patients in particular is also key when considering clinical research. “Latin American patients like having regular contact with their doctor and want to attend the medical center. This leads to a significantly lower dropout rate in clinical trials compared to Anglo Saxon countries. They get more involved and there’s higher adherence,” noted Dr. Pérez Manghi.
Even so, there is still plenty to work on as less than 5% of the world’s total clinical research is conducted in Latin America. The main challenge is generating more data, a subject that is still pending in the region. “Argentina is already addressing this issue by investing heavily in technology. An example of this, is the development of Alpha Clinical Research, a platform of digital medical record that we are implementing in CINME”, concluded Pérez Manghi.
[1] ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – National Administration of Drugs, Food and Medical Devices.
