In the last two decades, the number of clinical trials involving patients with lung cancer has seen an encouraging increase in Latin America. However, at the same time, there has been a worrying decrease in the number of investigations originating in the region. This drop could lead to the results derived from the studies not being fully applicable to the local population suffering from lung cancer.[1]
Dr. Thomas Miguel Knapp
The information comes from a retrospective study published in JCO Global Oncology with first author Dr. Thomas Miguel Knapp, a former medical student at the University of Central Florida in Orlando, United States.
“As a medical student, one of my main interests was cardiopulmonary physiology. That led me to lean towards cardiothoracic surgery. In addition, I had the need to integrate my interest in this field with my Hispanic heritage and the health care of Latin American populations,” he told Medscape in Spanish Dr. Knapp.
The doctor added that “the increase in overall participation in clinical trials over time is encouraging, and demonstrates the potential impact that collaborative groups in lung cancer research have had in the region.”
In addition, Dr. Knapp considered that “the observed decrease in the number of clinical trials originating in Latin America could serve as a catalyst for discussing those that are carried out in the future.”
Research through cooperative groups
The study searched the Clinicaltrials.gov registry and took into account 273 lung cancer clinical trials. All of them had been carried out in the region during the period 2001-2021.
The main objective was to determine the impact of the creation of cooperative groups aimed at promoting clinical research in Latin America. These are the Latin American Cooperative Oncology Group (LACOG) and the Latin American Lung Cancer Consortium (CLICaP). Both have been in force since 2009 and 2011, respectively.
During the period 2001-2011, there were up to 100 clinical trials in the region, but the number increased to 173 studies during the interval 2012-2021 (p < 0.001). Some countries such as Brazil (169 of 273; 62%), Mexico (128 of 273; 47%), Argentina (128 of 273; 47%), Chile (82 of 273; 30%) and Peru (51 of 273, 18%) lead the list of participations in these investigations.
About 66% of clinical trials identified between 2001-2021 were phase 3, and 88% of the total included patients with non-small cell lung cancer. Participants in most studies were in stage III (148 of 273; 54%) or IV (172 of 273; 63%).
On the other hand, the most commonly used pharmacological agents in Latin America were monoclonal antibodies (137 of 273; 50%) and tyrosine kinase inhibitors (79 of 273; 29%).
Dr. Luis Mas Lopez
“It is important how two cooperative institutions, such as the Latin American Lung Cancer Consortium and the Latin American Cooperative Oncology Group, have been the driving forces behind the development of lung cancer research in Latin America. Mainly because they share similar historical aspects and the problems are almost common to the entire region,” commented Dr. Luis Mas López, a specialist in oncology and coordinator of thoracic tumors at the Auna Oncosalud Clinic in Peru.
The expert, who did not participate in the study and is one of the founding members of the Latin American Lung Cancer Consortium, added that “the success achieved shows how feasible it is to create cooperative groups in Latin America. The leadership developed by those in charge of the coordination is extremely important and has been carried out in the most successful way, as it has resulted in an increase in research and the number of publications in indexed journals.”
Few clinical trials originate in Latin America
When the team of authors of the study focused on the origin of clinical trials, what was observed was a decrease in the number of investigations that had a Latin American country as their epicenter. They went from 14% in 2001-2011, to 7% during 2012-2021 (p = 0.058).
“This generally means that there are fewer patients from Latin America included in lung cancer research. On the other hand, large clinical trials originating from outside the region may have a low proportion of Latin American patients, and without adequate representation, it is not fully known whether the results can be extrapolated to the population of the region,” said Dr. Knapp.
For Dr. Mas López, the low representation of Latin America in these studies is also a cause for concern.
“This could be explained by a lack of interest on the part of sponsors in integrating the region into clinical trials, delays in regulatory times, a shortage of trained personnel, a very limited future commercial market, or a lack of participation in international cooperative groups,” he said.
According to the specialist, the path to reversing this trend in the region is difficult. That is why he called for the interdisciplinary participation of all the actors involved. He also stressed that it is necessary to integrate regulatory agencies to speed up approval processes, facilitate the regulatory aspect of research in local populations, strengthen cooperative groups and propose training for professionals in training.
Barriers to the future of lung cancer research
“In my opinion, the support provided by regulatory institutions for the development of studies that arise from the initiative of the researcher is not adequate and the competitive funds for sponsoring clinical research are limited. In addition, the approval times for studies by the responsible entity have been increasing and the number of studies per researcher has been limited. Considering that not all doctors carry out research, this is an invisible barrier,” stressed Dr. Mas López.
The authors of the article concluded that Latin American countries have made great progress in promoting clinical research into lung cancer, despite the various obstacles they experience related to funding and infrastructure.
For Dr. Knapp, it is imperative to continue supporting and funding groups such as the Latin American Lung Cancer Consortium and the Latin American Cooperative Oncology Group. Dr. Mas López took the opportunity to point out that these alliances “have arisen largely through the will and personal effort of researchers, breaking down barriers and bottlenecks that exist in Latin America for clinical research.”
“It is ideal for cooperative groups to be able to develop research into conditions specific to the region. We have non-smoking populations with mutations in the epidermal growth factor receptor. It is extremely important to investigate risk factors such as environmental pollution, exposure to radon gas or wood smoke. It is also important to be able to determine molecular factors for the prevention of lung cancer,” concluded Dr. Mas López.
The team of authors of the article has declared no relevant financial conflicts of interest. Dr. Mas López has declared no relevant financial conflicts of interest; he is one of the founding members of the Latin American Lung Cancer Consortium.