RIO DE JANEIRO, BRAZIL – Pharmaceutical sector specialists explained why in 2021, the country broke the decade record in the number of trials and described the multiple benefits that this generates.
Some improvements introduced by the National Administration of Medicines, Food, and Medical Technology (ANMAT) added to the prestige of the Argentine medical community at the international level and promoted a significant increase in the country’s overall participation in clinical trials during 2021.
Clinical trials are practices aimed at testing the efficacy of new drugs, devices, and other forms of treatment – also those already approved. Many clinical trials seek new ways to detect, diagnose, or measure the extent of a disease.
Clinical research, whose International Day was celebrated on May 20, makes an enormous contribution to the advancement of science for the benefit of health, providing excellent care and early access to potential drugs, in addition to the contribution it represents in the training of health professionals and the income of foreign currency as it is an export of services.
A series of ANMAT provisions introduced in 2017 streamlined the approval times of clinical studies, providing predictability. In addition, the digitalization of procedures added to the prestige of health professionals and institutions contribute to positioning Argentina as a benchmark in this activity, at the same time that the highest rate of clinical studies per million inhabitants was reached in the region, stated the Argentine Chamber of Medicinal Specialties (CAEME).
Multiple voices of the laboratories that focus on innovation contribute their views on this activity, how it contributes to improving the population’s health, and the growth it has been having in the last years.
Dr. Susana Baldini, Medical Director of CAEME, explained that the approval of clinical studies took about 140 days in 2018. Today, it takes 80, which allowed the country to be much more competitive against others to be chosen: “This, added to the rigorousness of the evaluation and regulation, the quality of health infrastructure, medical training, extensive experience, and good clinical practices, place Argentina in a very attractive plane for sponsors”.
Until recently, Clinical Research Day was essential to help give visibility to the subject because people were unaware of what clinical studies were and what benefits they brought. Today, however, the situation is different. As a survey conducted by the consulting firm Voices! at the request of CAEME showed, since the pandemic, people’s knowledge has increased significantly.
Thus, 3 out of 10 Argentines consider that they know a lot about the subject (twice as much as before March 2020), and 7 out of 10 would participate in a clinical trial, and not only in the face of diseases with no therapeutic option, but 6 out of 10 would do so for the very advancement of science.
BENEFITS OF CLINICAL TRIALS
Dr. Flavio Arce, Regional External Partnership Medical Lead for Latin America at Pfizer, explained that “this activity allows the development of new medicines that help to improve people’s quality of life, including innovative treatment options in therapeutic areas with unmet needs. In addition, it enables doctors and other health professionals to have access to state-of-the-art technologies at the same time as the rest of the world, providing training to our professionals, which raises quality standards and puts us on a par with the major foreign research centers,” he remarked.
Clinical research “promotes the advancement of science and allows patients to play an active and informed role in choosing treatment options. It empowers and facilitates access to new treatments,” said María Mercedes Noya, Manager of Regulatory Affairs for Clinical Research at MSD.
For Karina de Lazzari, president of CAOIC, the Argentine Chamber of Clinical Research Organizations, “developing clinical studies increases the reputation of the institutions and consolidates their participation in networks of the local and international scientific community”.
Diana Zubiri, Regional Clinical Operations Manager of Bristol Myers Squibb, said that clinical research “is an activity that contributes to train health professionals in aspects related to innovative drugs and potential new treatments”. He added: “It provides them with new work methodologies and allows them to be at the forefront of scientific knowledge”.
Dr. María Verónica Garay, Country Study Lead Site Management at Bayer, emphasized that “for a country like ours, clinical research is synonymous with excellent medical care, which strengthens our main objective, which is to collaborate with our activity to improve the quality of life of patients.
There is also a reduction in health expenses because health care is decompressed since study participants receive comprehensive care outside the health system, and the clinical study sponsor covers all the associated costs.
Clinical research also involves exporting services, a driving force for the local economy. Eighty-five percent of external financing of all research and development (R&D) sectors corresponds to investment in clinical R&D, and more than 63% of the resources with which clinical studies are financed come directly from the parent companies of the pharmaceutical companies involved, which translates into foreign currency income, which in 2020 represented US$20 billion.
According to the latest survey on Research and Development 2020 by the National Ministry of Science, Technology, and Innovation, the sector generated more than 3,200 jobs, representing 17% of the total human resources in research and development of the business sector.
For all these reasons, the participation of health institutions, both public and private, in clinical studies should be a global policy promoted so that it grows throughout the country, taking into account that, at present, it is mostly concentrated in Buenos Aires and private health centers.
Clinical research continues to be a risky activity in financial terms due to the investment it represents and the very low success rate of the approved molecules compared to those discovered.
For each one that ends up being approved, around US$2 billion is invested globally, and only 1 out of 5,000 to 10,000 discovered is approved by the FDA in a period that takes at least ten years.
Despite this low rate, laboratories that invest in research and development are convinced of the value of innovation to change people’s lives, and year by year, they increase their investment in this area, trying to optimize their processes and be increasingly assertive: in the world today there are more than 7,800 molecules in advanced stages of research.
LESSONS LEARNED DURING THE PANDEMIC
For Dr. Emma Venezian, Director of Sanofi’s Clinical Trials Unit for Cono Sur, “the greatest lesson learned so far, as far as scientific research is concerned, has to do with the optimization of processes to implement clinical trials: the urgency to identify effective vaccines and treatments for COVID-19 led very quickly to innovations in the design and conduct of clinical trials, achieving very efficient times in the generation and approval of research protocols”.
The pharmaceutical industry had to enhance technology and redefine processes to ensure continuity of treatment and medical care for patients participating in studies. It led the laboratories to implement the direct delivery of the drug under investigation to the patients’ homes, home care with specialized equipment, and the optimization of the use of remote digital processes for monitoring, data collection, real-time cross-referencing of information, and even inspections and audits, advances that, according to the specialists, are here to stay.
“All the necessary means were made available to the research centers and patients, prioritizing the safety and well-being of the participants. These measures were taken by informing all research stakeholders at every step: patients, researchers, ethics committees, and regulatory authorities,” explained Laura Rodriguez, senior Clinical Operations Lead at Roche.
“In good time, the pandemic has made us technology-friendly, bringing all stakeholders involved in research closer together through digital exchanges. As we advance, we hope that the growing adoption of technology at all levels will speed up study preparation times, increase the participation of individuals in trials and, ultimately, find innovative therapeutic alternatives more quickly that will allow us to transform the trajectory of health, contributing to the well-being of each patient,” said Mercedes Copteleza, Country Head Argentina, Global Clinical Operations, Janssen Laboratory.
CAEME stressed that the pandemic has made it clear that progress in healthcare must rely on innovation as an indispensable and permanent ally, recognizing that “they must continue to work together to ensure that, in the shortest possible time, innovations can reach the people who need them”.
With information from Infobae