Clinical research in Brazil - regulation is important and urgent!
Updated: Nov 2
By Cristina Balerine
The interviewee for the 7th Program on our YouTube channel was Dr. Fábio Franke, oncologist, coordinator of the Unimed Noroeste Hospital, in Rio Grande do Sul, president of Aliança Pesquisa Clínica Brasil (Brazil Clinical Research Alliance), and member of the Clinical Research Committee of the Brazilian Society of Oncology Clinic (SBOC/CRCBSOC).
Dr. Franke addressed issues that have been widely discussed in clinical research, such as regulation, difficulties in carrying out trials in Brazil and Bill no. 7082/2017, which aims to regulate clinical research with human beings and institutes the National System of Ethics in Clinical Research with Human Beings in Brazil.
Slow and bureaucratic regulatory process
Brazil currently ranks 24th in the number of clinical trials opened annually. According to Dr. Franke, there are still few trials in the country because we have very long and bureaucratic regulatory deadlines. This is reflected in a delay of up to more than a year for a study to be approved.
“We have advanced a little in recent years, but our lack of predictability, in terms of deadlines, still persists, which does not attract sponsors to carry out the trials. It is very frustrating to lose the possibility of conducting a study due to excessive bureaucracy.”
Dr. Franke stressed that the country needs to have a law that provides legal certainty for conducting research. “We currently have regulations that can be easily changed, which does not provide neither security for the research sponsor, nor for the patient, or even for the researchers.”
In order to establish a regulatory framework for clinical research and create a process that is in harmony with the good practices adopted by other countries, Bill 7082/2017 was proposed.
Know the project
According to Dr. Franke, the Bill 7082/2017 (former Bill 200/2015), authored by senator Ana Amélia, if approved, could make Brazil jump positions in the number of clinical research carried out in the country. “We would go from 24th position to 10th place. In practical terms, this means that we would have a 2.5-fold increase in the number of trials performed here, immediately benefiting more than 155,000 patients per year.”
The Project establishes who the main actors are in the process of designing and implementing a clinical trial, the roles that each one plays, in addition to the rights and duties of each involved party and, equally important, also the rights of patients. It also establishes a maximum period of 90 days for the research to be approved, among other topics. “This would give us the much-desired predictability that investors look for when they want to support research in a country,” he says.
Dr. Franke also highlighted that research carried out in the country contributes to the construction of a real world evidence base, which provides greater support for decisions to incorporate new technologies.
In August of this year, the Bill was approved by the Constitution and Justice and Citizenship Committee and is now being voted on in the Chamber of Deputies. “We need to sensitize party leaders so that the Bill is voted on. We depend on this awareness so that they understand the importance of this topic for science and for Brazilian patients”, he concluded.