Fiocruz launches world's first AI for the registration of clinical trials

Brazilian and foreign researchers dedicated to clinical trials in the country - or even abroad - can, as of 03/24, count on the help of Rebec@, the world's first generative artificial intelligence tested and trained to assist in the registration of clinical trials according to the guidelines of the global network International Clinical Trials Registry Platform (ICTRP), the World Health Organization's gold standard for information transparency. Rebec@ is one of the many innovations of the Brazilian Registry of Clinical Trials (ReBEC), a trilingual platform managed by Fiocruz's Vice-Presidency for Research and Biological Collections (VPPCB).

Connected to an up-to-date learning base on regulation and good practices in clinical trials, Rebec@ will operate 24 hours a day, 7 days a week - the same availability regime as the Brazilian platform. It will be able to provide a proper answer about the documents and deadlines considered valid for submitting records, the types of studies, the rules for approval, and even how to become a volunteer for the trials.

Moreover, the robot works with a list of themes - health conditions, diseases, specific populations, etc. - considered to be priorities by the Ministry of Health and the WHO. For some of them, ReBEC already has fast-tracks, which are express review routes with approval within 48 hours. Rebec@ can help each registrant identify whether their trial is among these priorities.

The Vice President of Research and Biological Collections at Fiocruz, Maria de Lourdes Aguiar Oliveira, says that, later this year, ReBEC should incorporate fast-tracks for studies with all the pathogens defined as priorities by WHO in Latin America. "We want to hold a global launch of these innovations on May 20th, the International Clinical Trials Day, as part of the ICTRP network's program at the 78th World Health Assembly in Geneva." Brazil is the only country in the world with express approvals for some of the priorities in the region, as well as fast-tracks for studies involving indigenous and traditional populations.

Maria de Lourdes assures that all services will continue to be free to the public. "Each functionality has a very low cost and is sustainable not only because it optimizes resources today. The effect is exponential, with cumulative positive externalities that affect the entire innovation chain. Speeding up national and international scientific collaboration and transparency of information means faster availability of vaccines and other innovations to society. The impact on the SUS [Unified Health System] is direct," she emphasizes.

The robot has already been tested informally by ICTRP. Only trials with a Clinical Trials (USA) registration or on ICTRP network platforms, such as ReBEC are accepted by the most recognized scientific journals. "This makes all the difference, especially in situations of risk and health emergencies, such as pandemics, in which scientific collaboration and the publication of results require credibility, even in a race against time," explains ReBEC coordinator Luiza Silva.

More than a chatbot

Luiza Silva and Josué Laguardia, the professors responsible for coordinating the Brazilian Registry, point out that Rebec@ can greatly speed up service, as there are patterns that are repeated among the dozens of users who pass through the Registry's human reviewers daily - a team of ten people who meet the global demand for human chat, which is now approved by 90% of users. "Rebec@ can deal with these frequently asked questions around the clock, while the reviewers deal with the other cases on a personalized basis during the Foundation's working hours, either promptly or by appointment," explains Laguardia.

For Diego Tostes, Rebec@'s creator and "trainer", generative chat is just one of its possibilities, as the robot recognizes and can give opinions on fields filled in by researchers. "We have now started training on identifying inconsistencies and generating options and responses that are flexible enough to help our reviewers speed up approval with quality and security. The results are encouraging and we may be able to integrate it into the definitive version," he says.

Also responsible for ReBEC's security and technological development, Tostes said that the next step will be to train the AI to act as an optional assistant to researchers in real time, in the filling environment. "There will certainly be a reduction in the number of failures and approval will be much quicker." To this end, during the beta test, there will be parallel investment in other AI tools to expand Rebec@'s talents and capacity.

Leadership

The Vice President said that ReBEC's planning until 2026 also includes the first Registry of Trial Centers in Brazil, already underway, and the resumption of the recruitment application designed by ReBEC coordinator Luiza Silva as a research project back in 2016, for the Zika epidemic, but which stalled due to lack of resources in 2019, on the eve of COVID-19. Silva is betting that Rebec@ will be able to attract and help researchers from other countries with research interests in Latin America to register in the Brazilian database in Spanish and English. Brazil would be the trilingual hub, due to its gold-standard compliance, personalized service, and a multilingual virtual assistant who can talk to experts of various nationalities who have studied on the continent.

"We believe that this could be the start of a truly integrated research ecosystem for the region and that it could be viable to act as a primary registration incubation condominium for countries that do not yet have our expertise in information curation in the ICTRP standard. We are trying to understand the ethical regulations of neighboring nations," Laguardia recalls.