Brazil's Regulatory Transformation: Expanding Clinical Trial Participation
A conversation between Brazil Ministry of Health’s Maiko L. Tonini, Ph.D., and Clinical Leader Executive Editor Abby Proch
Bolstered by Law No. 14,874/2024, Brazil is intent on redefining how it conducts clinical research. And if you’ve kept tabs on evolving regulatory frameworks, you’ll know that the country has made significant strides to improve processes and reduce timelines for sponsors conducting trials there.
Based on discussions at September’s “Clinical Development in LATAM: Brazil Unlocked,” this Q&A series examines what those changes mean in practice for global clinical research organizations.
This second installment features Maiko L. Tonini, Ph.D., general coordinator of research regulation and ethics at Brazil’s Ministry of Health. He discusses how Brazil’s regulatory modernization, stronger research and referral networks, expanded infrastructure and workforce development, and more reliable data can broaden clinical trial participation and strengthen confidence in recruitment forecasts.
Clinical Leader: From your perspective at the Ministry of Health, what is the most important change that will enable Brazil’s large and diverse patient population to increase enrollment in clinical trials?
Maiko L. Tonini, Ph.D.: Brazil's population is one of its greatest strengths in clinical research, and it is closely followed by our comprehensive unified healthcare system. The most important change is to bring research closer to patient care, as many patients receive treatment at healthcare facilities that do not conduct research or have established relationships with research centers. This will also help reach patients receiving care outside major research institutions.
Important changes are already happening. Law No. 14,874/2024 established the National Research Ethics System (Sinep). It introduced a single ethics review for multicenter studies, meaning that the opinion issued by the responsible Research Ethics Committee (REC) is valid for all participating sites covered by the approved protocol, eliminating repeated ethics reviews.
In addition, the federal government announced an investment of BRL 120 million to strengthen infrastructure and expand national clinical research capacity through the National Clinical Research Program (PPClin), which includes strengthening the Brazilian Clinical Research Network, mapping existing research capacity, and qualifying research centers.
What does an effective recruitment network look like in practice, and what can research centers, hospitals, community physicians, patient groups, and government do to support it?
An effective network requires integration between healthcare delivery and research, well-equipped centers, trained teams, and clear referral pathways to identify eligible patients. Treating physicians, research coordinators, and patient organizations are essential to this process, including helping to overcome barriers to participation. The Ministry of Health supports these efforts through PPClin and initiatives focused on professional training and development in clinical research.
This work must consider the patient's journey through the healthcare system. In oncology, for example, without access to biomarker testing and appropriate referral pathways, potentially eligible patients may never be identified.
The National Research Ethics Authority (INAEP) is working to expand the network of accredited RECs capable of reviewing higher-risk and more complex clinical studies, including cell and gene therapies. These efforts aim to make ethics review and study start-up more predictable while maintaining the rigorous standards needed to protect research participants.
Where did you hear the strongest agreement — or disagreement — among attendees about the data, infrastructure, or governance needed for sponsors to trust recruitment forecasts from Brazilian networks?
At the event in Boston, there was broad agreement about Brazil's recruitment potential and the importance of reliable data for clinical trial planning. I did not observe significant disagreements about this potential, although participants expressed different concerns about the accuracy of recruitment forecasts.
An estimate of how many patients have a particular medical condition does not necessarily translate into a recruitment forecast. Study eligibility criteria and research site capabilities must also be considered. For the Ministry of Health, ensuring data quality, representativeness, and appropriate governance is equally important.
The National Registry of Clinical Research Centers, currently being developed by the Ministry of Health, will map infrastructure, workforce, and areas of expertise, helping guide public investment and providing more reliable information about the capabilities of Brazilian research centers.
Over the next three years, what should the Ministry of Health and other stakeholders prioritize to connect regulatory modernization with durable referral and recruitment infrastructure?
Over the next three years, our priority is to build on the progress made through Brazil's new regulatory framework, INAEP, and PPClin to expand the country's clinical research capacity. This includes increasing the number of accredited RECs across all regions, strengthening research centers, including those conducting early-phase trials, and investing in workforce development. We also aim to improve coordination between INAEP and ANVISA, while respecting their respective responsibilities, to make ethics and regulatory reviews more predictable.
We are developing a new national digital platform for research involving human participants to improve transparency and timeline monitoring. Together with the National Registry of Clinical Research Centers, this initiative will help guide investment and strengthen research and recruitment networks. Other priorities include developing biobanks and genomic databases, expanding real-world evidence studies within Brazil's Unified Health System (SUS), and strengthening international partnerships and initiatives supporting the development of Brazilian health technologies.
In Boston, we presented preliminary findings from an analysis covering 528 records of privately sponsored trials. The estimated time to a final ethics review outcome decreased from 59 to 36 business days between 2024 and 2026. The next step is to monitor site activation and actual patient enrollment.
The success of this agenda should be measured by growth in the number and quality of clinical trials and real-world evidence studies, increased participation and greater diversity among research participants, broader regional distribution of research, strong ethical protections, and the progression of Brazilian-developed technologies into clinical development. Our goal is to establish Brazil as an international hub for health research and innovation, capable of generating evidence that informs decisions and delivers tangible benefits to the population.
About The Expert:
Maiko Tonini is a federal civil servant (science and technology career) at Brazil’s Ministry of Health, where he serves as general coordinator for regulation and research ethics within the Department of Science and Technology (DECIT/SCTIE). He is deputy coordinator of the National Ethics Research Authority (Inaep). He is experienced in managing, funding, and monitoring strategic health research portfolios aligned with Brazil’s Unified Health System (SUS). He holds a B.Sc. in pharmacy and biochemistry, an M.Sc. in biotechnology and biosciences, a Ph.D. in molecular and cellular biology, and completed a postdoctoral research fellowship at Cleveland State University (Ohio, USA).