PRIORITY SERVICES

The Brazilian Registry of Clinical Trials (ReBEC) presents the new fast tracks for clinical research and observational studies on INDIGENOUS PEOPLE AND TRADITIONAL COMMUNITIES and on NEGLECTED TROPICAL DISEASES (NTDs). Fast-track can reduce the normal approval period for clinical trials to less than 48 hours, if the documentation, information and any mandatory changes requested are provided by the registrant.

The already existing fast-tracks and the attendance to other studies will not be interrupted. Priority care is granted with a view to accelerating clinical research in epidemiological emergency situations and/or studies with the potential to reduce socioeconomic inequalities, keeping the perspective aligned with the forefront of ethics and transparency, diplomacy in health, scientific collaboration and diversity and specificities of recruitment and health care.

FAST-TRACKS IN OPERATION:

I - Indigenous Peoples, Traditional Communities, Human Migration and Refugee Movements – clinical research and observational studies dedicated to or preferably addressing traditional communities (quilombola, caiçara, faxinalense, among others), Indigenous peoples (within or outside legally demarcated territories), and refugee groups, taking into account the specificities established by regulation, on a case-by-case basis.

II - Neglected Tropical Diseases – Leprosy, Tuberculosis, Leishmaniasis, Schistosomiasis, Scabies, Chagas disease, Intestinal parasitoses, Viral hepatitis, Trachoma, Onchocerciasis, Human rabies transmitted by dogs.

III - National and International Public Health Emergencies – Mpox, Covid-19.

IV - Arboviruses – Zika, Dengue, Chikungunya, Malaria, Yellow fever.

V - WHO Prioritized Pathogens for Latin America – Studies dealing with World Health Organization prioritized pathogens for Latin America, as listed in the document "PATHOGENS PRIORITIZATION - A SCIENTIFIC FRAMEWORK FOR EPIDEMIC AND PANDEMIC RESEARCH PREPAREDNESS" (Health Emergencies Programme, 2024) – Lassa fever, Cholera, Black Death (Plague), Bacillary dysentery or Shigellosis, Salmonella, Pneumonia, Urinary tract infection, MERS-CoV, SARS, Ebola virus (EVE), Marburg virus (MVE), Ebola virus (EVE) Sudan subtype, Hantavirus pulmonary syndrome (HPS), Hemorrhagic fever with renal syndrome (HFRS), Crimean-Congo hemorrhagic fever, Influenza A H1, Influenza A H2, Influenza A H3, Avian influenza (Influenza A H5N1), Avian influenza (Influenza A H6), Avian influenza H7 (Avian influenza H7), Avian influenza H10 or Avian influenza H10, Nipah disease, Viral hemorrhagic disease, Poliomyelitis, Hand-foot-and-mouth disease, Herpangina, Viral meningitis, Smallpox, Mpox, Human Immunodeficiency Virus (HIV), Venezuelan equine encephalitis (VEE).

VI - WHO Prioritized Prototype Pathogens for Latin America – Studies dealing with World Health Organization prioritized prototype pathogens for Latin America, as listed in the document "PATHOGENS PRIORITIZATION - A SCIENTIFIC FRAMEWORK FOR EPIDEMIC AND PANDEMIC RESEARCH PREPAREDNESS" (Health Emergencies Programme, 2024) – Recombinant mastadenovirus, Mastadenovirus blackbeardi serotype 14, Mammarenavirus juninense, Mammarenavirus lujoense, Mamastrovirus virginiaense, Orthobornavirus bornaense, Orthoflavivirus encephalitidis, Orthoflavivirus nilense, Orthohepadnavirus hominoidae genotype C, Paslahepevirus balayani genotype 3, Protoparvovirus carnivoran, Orthobunyavirus oropoucheense, Phlebovirus riftense, Orthopicobirnavirus hominis, Enterovirus alphacoxsackie 71, Enterovirus deconjuncti 68, Metapneumovirus hominis, Orthopoxvirus vaccinia, Genus Vesiculovirus, Genus Rotavirus, Orthoreovirus mammalis.

VII - Studies on the impacts of climate change, the effects of scientific denialism, and health misinformation -The physical, mental, and social consequences of environmental and climate changes on human populations; The impact of extreme weather events and environmental degradation on infectious, chronic, or emerging diseases; The influence of denialist narratives and misinformation in Health on adherence to preventive measures, vaccination, treatments, and risk behaviors, as well as the physical and mental outcomes for human beings and populations.

INSTRUCTIONS:

We recommend reading the Registrant Handbook. Material available at LINK.

1. Register or log in and normally fill out the forms in Portuguese and English. For English, in case of difficulty, use the Google Translate tool (or another free translation tool).
2. Attach the mandatory ethics committee documentation and submit the form.
3. Register the service number on your Whatsapp. Send a message with your name and login. IT IS NOT NECESSARY NOR RECOMMENDED TO SEND YOUR PASSWORD.
4. A reviewer will respond to you. Choose the service modality: chat, audio recordings or voice call by appointment.
5. Your form will be proofread in both languages. Follow the remaining guidelines to finalize the approval.

CONTACTS:

ReBEC support is provided exclusively by official online channels.

Service channels:
* IA ReBEC@ (virtual assistant): automated service 24 hours a day, 7 days a week
* Humanized chat: from Monday to Friday, from 8 a.m. to 12 p.m. (Brasília time)
* Institutional WhatsApp / Dedicated line: +55 21 97203-4750
Service from Monday to Friday, from 9 a.m. to 4 p.m. (Brasília time)

Priority and/or urgent administrative demands outside the file schedule may be submitted to: plantao.rebec@gmail.com

We recommend that all requests be accompanied by a login, linked email or study registration number. (RBR-xxxxxxx), when applicable, for agility in attention.

ABOUT REBEC:

The Brazilian Registry of Clinical Trials (ReBEC) is a free access virtual platform for recording experimental and non-experimental studies carried out on human beings and conducted in Brazilian territory, by Brazilian and foreign researchers. ReBEC is a joint project of the Ministry of Health (DECIT/MS), the Pan American Health Organization (OPAS) and the Oswaldo Cruz Foundation (FIOCRUZ). ReBEC's Executive Committee is composed of the aforementioned institutions and the National Health Surveillance Agency (ANVISA).

06/19/2026  |  Dan Schell  |  Clinical Leaders

https://www.clinicalleader.com/doc/where-are-we-with-clinical-trial-tokenization-0001 

Back in January 2024, I interviewed Tom Dougherty about a topic many clinical research professionals had heard mentioned but few could confidently explain: tokenization. More than two years later, that article remains one of the most-read pieces ever published on Clinical Leader.

Why?

Well, I’d be guessing, but I think it’s because tokenization is one of those topics that seems to get more relevant every year. The concept touches everything from RWE and AI to patient privacy and long-term follow-up. It offers the possibility of learning more from clinical trial participants without asking more of them, but … and this is a big but … it also raises important questions about how data is used and protected. That's a combination that tends to make people perk up, especially during an ICF explanation.

Today, with growing interest in RWE, external control arms, and more connected data ecosystems, it seemed like a good time to revisit the topic and find out how much progress the industry has actually made. By the way, since 2024, Tom has joined Novo Nordisk as Real-World Data Strategy Director, CMR - Clinical Data Science & Evidence. Here is our Q&A.

1- When we last spoke in 2024, tokenization still felt a bit like a “future state” capability. Where are we today in terms of actual adoption? Are sponsors truly operationalizing tokenization at scale, or are we still mostly in pilot mode? 

Tom Dougherty: Today, I’d say adoption is real, but it’s still selective rather than universal. In the US, a lot of sponsors, academia, and CROs have moved beyond pure pilots, and tokenization…

06/18/2026  |  Osborne Clark

https://www.osborneclarke.com/insights/eu-introduces-harmonised-template-clinical-trial-recruitment-and-consent 

A single EU-wide structure now governs how sponsors document recruitment and informed consent across all member states

The European Commission's expert ethics committee group MedEthicsEU has released a revised template for clinical trial recruitment and informed consent procedures as part of volume 10 of EudraLex, the EU's rules governing medicinal products.

Endorsed by the EU Clinical Trials Coordination and Advisory Group (CTAG), the template is designed to harmonise how sponsors document Part II recruitment and consent arrangements across the EU and European Economic Area for clinical trials authorised under Regulation (EU) 536/2014 (CTR). The arrival of the template consolidates what has been a fragmented landscape in which national Part II expectations have varied considerably across member states. It formalises a single six-section structure that should now be used for all new submissions. The CTR itself may be subject to further change if and when the proposed EU Biotech Act becomes law.

Recruitment guidelines
Section 1 of the template requires sponsors to articulate, in concrete terms, how potential participants will be identified and whether that process involves access to identifiable data such as existing patient lists or medical records. The distinction between identification that involves access to identifiable data, such as existing patient lists or medical records that the template explicitly mentions, and approaches that do not may carry different implications under national data protection regimes.

The template also prompts sponsors to identify the first act of recruitment under section…

06/19/2026  |  Beata Pasek  |  KevinMd.com

https://kevinmd.com/2026/06/why-clinical-trials-fail-before-enrollment-even-begins.html 

When a clinical trial starts to struggle, the conversation almost always turns to enrollment, with recruitment numbers running low and retention becoming increasingly difficult to maintain as timelines slip and pressure mounts. Sponsors and study teams begin asking how enrollment can be improved, accelerated, or rescued, often treating it as the central problem that needs to be solved.

But after more than fifteen years working inside clinical research operations across academic medical centers, industry-sponsored trials, and multi-site studies, I have come to believe something uncomfortable about all of this. Many trials are already struggling long before enrollment begins to fail. The operational cracks often appear quietly at the beginning. A protocol may be scientifically strong but operationally unrealistic. Study teams inherit timelines disconnected from clinical workflow realities. Communication becomes fragmented across sponsors, contract research organizations (CROs), investigators, coordinators, and regulatory teams. Small inefficiencies accumulate long before recruitment numbers visibly decline.

Then the study opens.

At first, everything looks fine. Meetings happen, metrics get reported, and timelines move forward. Behind the scenes, the operational burden starts shifting onto the people closest to the work, including coordinators, nurses, project managers, regulatory staff, data teams, and eventually patients themselves. By the time enrollment visibly struggles, deeper structural problems may have existed for months.

This is not a criticism of the people working inside clinical research. Across my career, I have worked beside extraordinary coordinators, investigators,…

06/18/2026  |   Wallace Graciano  |  O Tempo

https://www.otempo.com.br/politica/2026/6/18/anvisa-aprova-novos-testes-de-medicamentos-em-humanos.amp 

The agency authorizes clinical trials by companies such as Pfizer, Roche, and Merck for the development of experimental treatments in Brazil.

The Brazilian Health Regulatory Agency (Anvisa) has approved a series of requests to conduct and modify human trials (clinical trials) for various experimental drugs. The decision was formalized by Resolution RE No. 2,414, published in the Federal Official Gazette on Wednesday, June 17, 2026.

The measure, signed by the Coordination of Clinical Research on Medicines and Biological Products, authorizes major pharmaceutical companies to continue or initiate new phases of scientific studies in the country. The approval covers everything from modifications to products already under investigation to authorization for new development dossiers.

Authorized Drugs and Companies
Anvisa’s resolution includes a diverse list of substances intended for the treatment of various health conditions. Among the highlights are immunotherapies and experimental gene therapies.

The authorized items and the respective companies responsible are:

• PPD do Brasil Suporte a Pesquisa Clínica Ltda. — substances mRNA-4157 (V940) and Barzolvolimab
• Produtos Roche Químicos e Farmacêuticos S.A. — substance RO7790121
• GlaxoSmithKline Brasil Ltda. — Belantamab (GSK2857914)
• Merck S/A — substances M5049 and MSC2584939A
• CTI Clinical Brasil Serviços de Pesquisas Clínicas — Siplizumab (TCD601)
• Pfizer Brasil Ltda. — substances PF-08634404 (SSGJ-707) and Ponsegromab (PF-06946860)
…

06/17/2026  |    Vivass Comunicação for Paraíba Total

https://paraibatotal.com.br/2026/06/17/da-pratica-clinica-a-duvida-online-78-dos-medicos-e-49-dos-pacientes-digitalizados-utilizam-ia-na-saude-no-brasil/ 

A survey conducted by Afya and Conexa indicates that AI is gaining ground in medical practice, but the final decision remains with the healthcare professional

In Brazil, 78% of doctors use artificial intelligence in clinical practice. The data comes from the survey “Overview of AI Use in Healthcare: The Doctor’s and Patient’s Perspectives,” conducted by Afya—Brazil’s largest ecosystem for education and solutions in medical practice—in partnership with the healthtech company Conexa. Conducted between November 2025 and January 2026, the survey interviewed 551 doctors and 511 patients nationwide and has a 95% confidence level, with a margin of error of 4 percentage points.

The survey indicates that adoption of the technology is widespread, but human oversight remains non-negotiable. Proof of this is that 63% of doctors report having already corrected an error generated by an AI tool before using the information in clinical care. Doctors who are more familiar with digital tools (73%) are precisely those who most frequently report inconsistencies generated by AI and, at the same time, those who are most successful at identifying and correcting them before applying any recommendations, indicating a more conscious and critical use of the technology.

At Afya Paraíba, where digital transformation is also advancing in the healthcare sector, the use of artificial intelligence has been gaining ground among both professionals and patients. Medical schools, clinics, hospitals,…