New Policy Shows Promise for Clinical Trials in Brazil

On June 15, the Global Alliance for Patient Access brought together patient associations, research institutions and medical societies to discuss clinical trials barriers – from the delay in regulatory analysis and lack of research sites to the need for greater awareness and education.  

One potential solution, meeting participants noted, is policy 7.082/2017. If passed, this policy would reduce the approval timeline to establish and conduct a clinical trial to a maximum of 120 days and give local ethical committees approval authority. Fernando de Rezende Francisco of ABRACRO noted that by decreasing the current drawn out timelines, the policy could attract investments, promote innovation and provide access to advanced therapies. It could also help ensure patient safety and enhance opportunities for health care professionals, he said. 

Although the policy addresses some barriers to clinical trials in Brazil, other challenges still require solutions. Meeting participants emphasized the need for comprehensive education and awareness campaigns to address doubts and fears among patients. They also suggested improving health care professionals’ understanding of clinical trials. Strengthening medical education related to clinical research would empower physicians to provide accurate information and support, fostering trust and increasing patient participation.  

Increasing the number of research centers across the country would provide more opportunities for patients in all geographies to access clinical trials, meeting participants added. 

While challenges are multifaceted, the new 7.082/2017 policy holds great promise for attracting investments, driving innovation and providing patients access to cutting-edge therapies. Collaboration among patient associations, medical societies and research organizations will be crucial in moving toward the shared goal of improving patient access and advancing health care outcomes.