In Brazil, clinical trials have become an essential opportunity for cancer patients, especially those with few effective treatment options.
Worldwide, clinical trials are fundamental tools for advancing treatments against , providing patients with the opportunity to access innovative therapies that are not yet available through conventional treatments. Although the importance of these studies is widely recognized, patient participation in research protocols faces major challenges. Among the main barriers are regulatory issues, the concentration of research centers in large urban centers and patients’ lack of knowledge about the benefits and role of clinical trials.
In Brazil, clinical trials have become an essential opportunity for cancer patients, especially those with few effective treatment options. These studies also represent an alternative for patients in the Unified Health System (), offering access to innovative treatments not yet available in the public network. In addition to strengthening national scientific research, participation in these studies allows Brazilians early access to promising therapies.
Data from ClinicalTrials.gov, an international clinical trial registration website, shows that Brazil showed a significant increase in the number of trials, with approximately 586 new studies per year until 2016. During the Covid-19 pandemic, the country was chosen to conduct 21 international tests of vaccines and treatments, which demonstrates global confidence in Brazil’s clinical research capacity. However, when it comes to oncology, Brazil still needs to move forward. Currently, the country occupies the twentieth position in the number of clinical research protocols in cancer, a position that has remained stable over the last ten years.
It is estimated that less than 5% of cancer patients in Brazil participate in clinical trials, and the development and approval of new cancer drugs can take 10 to 15 years. Many of these studies are only accessible in large research centers in developed countries, which limits access for a wide range of people, especially those in remote or low-income areas. Therefore, international collaboration is essential to expand patient access and accelerate the development of new treatments and prevention strategies.
To change this scenario, it is necessary to invest in infrastructure, train professionals and promote partnerships with international institutions. The National Health Surveillance Agency (), responsible for regulating clinical trials in Brazil, has been implementing improvements to make processes more agile and allow more patients to participate. Furthermore, the Brazilian Clinical Trials Registry (ReBEC), created in 2010, promotes transparency and facilitates public access to information about ongoing studies, encouraging the participation of researchers and volunteers. Despite advances, Brazil still faces obstacles that limit patient participation. They are:
1. Geographic Distribution: most research centers are concentrated in cities such as São Paulo and Rio de Janeiro, making access difficult for patients from distant regions. Many Brazilians need to travel long distances to participate, which increases costs and creates logistical challenges.
2. Regulatory Obstacles: Although Anvisa has taken measures to speed up approvals, the regulatory process can be time-consuming. The approval of a clinical trial in Brazil involves several bodies, including the CEP/CONEP System for ethical evaluation, in addition to Anvisa itself. This process, although necessary to ensure the safety of participants, represents a barrier to the rapid start of studies.
3. Socioeconomic Barriers: Many studies are open in a few locations in the country, which often makes access difficult for patients living in more remote areas. Despite the travel costs to be covered by the companies that sponsor the research, the local doctor is often not able to identify that a specific patient is eligible for an open study in another center, especially at a long geographical distance.
To face these challenges, regulators and health institutions in Brazil have been looking for ways to decentralize clinical trials, drawing inspiration from international experiences. Technologies such as telemedicine and remote monitoring, for example, can reduce the need for travel for patients in remote areas. Furthermore, partnerships with public hospitals in distant regions can expand access, allowing a greater diversity of patients to participate in trials.
It is expected that Brazil will be increasingly requested for international clinical trials, attracting pharmaceutical companies interested in taking advantage of the country’s population diversity and experience in clinical research. During the pandemic Brazil stood out as one of the main research centers for the development of vaccines and treatments. This recognition strengthens the country’s position in global science and allows local patients to have early access to innovative treatments.
To improve adherence to clinical trials, it is essential that the population understands the benefits of these researches. Education campaigns can help improve communication between doctors and patients, encouraging more people to enroll in these studies and ensuring they are well-informed about their treatment options.
Clinical trials in Brazil are essential to ensure that medical advances reach a diverse population. Overcoming geographic, regulatory and socioeconomic barriers is essential to increasing participation and strengthening the country’s position in global clinical research. With strategies such as the decentralization of trials, simplification of processes and public education, Brazil will be able to continue expanding access to innovative cancer treatments, benefiting patients and contributing to global scientific progress.
*By Dr. Carlos dos Anjos – CRM 129177
Clinical Oncologist at Hospital Sírio-Libanês
