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:

Support is online, via chat, dedicated telephone line (see phone number below) and WhatsApp, from 9 am to 5 pm (Brasília time).

Administrative, priority and/or urgent matters outside office hours: plantao.rebec@gmail.com
Line 1: +55 21 97203-4750

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).

01/30/2026 | Marcos Patullo | Migalhas

https://www.migalhas.com.br/depeso/448888/polilaminina-a-luta-judicial-por-um-tratamento-para-lesao-medular 

The judicialization of access to medication exposes the conflict between the right to health, medical urgency, and regulatory requirements of ANVISA (Brazilian Health Regulatory Agency).

The fundamental right to health and life, enshrined in the Federal Constitution, frequently clashes with the regulatory barriers of the health system. One of the most complex arenas of this dispute involves access to medications that are not yet registered with ANVISA, but currently represent the only hope for patients with serious conditions and no therapeutic alternatives. The legal battles surrounding access to Polilaminina, a promising biopharmaceutical for the treatment of acute spinal cord injuries, illustrate the complex balancing of interests between medical urgency and public health safety.

What is Polilaminina?

Pollilaminina is a biopharmaceutical developed over more than two decades of research by UFRJ - Federal University of Rio de Janeiro, in partnership with the Cristália Produtos Químicos Farmacêuticos laboratory. Derived from laminin, a protein found in human placentas, the substance targets the regeneration of lesions in the nervous system. Administered intramedullary, Polilaminina has demonstrated significant potential in preclinical studies and early phases of clinical trials for improving motor function in patients with acute spinal cord trauma, a devastating condition that frequently results in permanent paralysis.

The main obstacle to its widespread use is the fact that the drug is still in the clinical research phase and does not yet have definitive sanitary registration from ANVISA (Brazilian…

02/02/2026  |  Edith Siméon  |  DDN/Drug Discovery and Development

https://www.drugdiscoverynews.com/how-estimands-are-changing-the-way-clinical-trials-are-designed-16976 

By explicitly specifying treatment effects and intercurrent events, estimands help sponsors, clinicians, and regulators work from a shared understanding.

At its core, an estimand defines the treatment effect a clinical trial is designed to estimate — in other words, the precise question the study is trying to answer. By explicitly stating what is being compared, in whom, on what endpoint, and under which circumstances, estimands bring clarity to trial objectives and ensure that all stakeholders are aligned from the outset.

This clarity matters. Clinical trials often generate ambiguity when protocol design, data collection, analysis, and interpretation are not fully aligned. Estimands address this by creating a shared framework that connects the clinical question to the statistical analysis, helping teams avoid misinterpretation and increasing confidence in trial results.

Recognizing this need, the International Council for Harmonisation (ICH) E9(R1) guideline on statistical principles for clinical trials formalized the estimand framework, giving the industry a common language to discuss key aspects of trial design. While the individual components of an estimand are not new, the requirement to define them explicitly at the protocol stage has fundamentally changed how sponsors, statisticians, clinicians, and regulators interact and collaborate. Used effectively, the framework aligns teams around a shared understanding of what a trial is truly designed to answer, while supporting sponsors in trial planning and regulators in their review.

An estimand comprises five key elements: the treatment…

02/02/2026  |  Health Innovation News Network

https://www.innovationnewsnetwork.com/improved-access-clinical-trials-could-improve-outcomes-for-patients-with-rare-cancers/66099/ 

Patients with rare cancers now have a better chance of survival due to a new government approach to clinical trials and access to breakthrough treatments.

As part of the government’s new National Cancer Plan – and the Rare Cancers Bill, which was introduced by Dr Scott Arthur MP and is currently going through Parliament – patients will be able to take part in clinical trials through the NHS App.

This gives them the chance to benefit from innovative approaches and technology to help fight the diseases.

Secretary of State for Health and Social Care, Wes Streeting, said: “We’re modernising the NHS so rare cancer patients not only get breakthrough treatments faster, but so we have more experts in the right places able to boost survival rates for rare cancers across the country.

“The National Cancer Plan marks a step‑change for brain cancer and rare cancer patients, giving researchers the tools they need and patients the hope they deserve.”

Easier access through the NHS App
Initially, patients will be able to search for trials on the clinical research database and ask to be contacted.

In time, patients with rare cancers will be able to sign up to automatically receive details of clinical trials that might benefit them.

Expanding the ‘doctor in your pocket’ NHS App is about creating a truly empowering, digitally enabled NHS, from booking a GP appointment, to managing existing care, all the way to receiving notifications on the latest research trials and state-of-the-art treatment.

02/02/2026  |  Annabel Kartal Allen  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/biorce-series-a-funding-round-ai-clinical-trials/ 

The AI-powered startup will now look to scale its global footprint and its clinical trial platform, Aika.

Spanish healthtech company Biorce has secured $52.5m through a Series A funding round to support the global rollout of its artificial intelligence (AI) clinical trial programme.

The financing round, which includes investors TZR Capital, Endeavour Catalyst, Norrsken VC and Mustard Seed Maze, as well as angel investors like Revolut CEO Nik Storonsky and Mistral AI co-founder and CEO Paulo Rosado, will see the company expand from its roots in Barcelona to the US, while further developing the global scaling of its AI-powered technology.

At the heart of this funding round is Aika, Biorce’s clinical trial platform. The company designed Aika to optimise trial design and operations – allowing study operators to create “regulator-ready protocols” in 90 seconds with 86% accuracy.

Built on a data pool of over one million clinical trials, the disease-agnostic technology functions through a multi-modality approach, Biorce’s CEO, Pedro Coelho, tells Clinical Trials Arena.

“Aika employs a mixture of task models. They are all trained to conduct a single task, while working together to create a protocol that is very likely to gain approval from regulators,” he said.

When generating a protocol, Coelho noted that Aika mirrors the way in which a human would approach the process. It achieves this by creating a best protocol first, which can then be tailored to a specific sponsor’s requirements before it is submitted to health authorities.

It also helps to reduce the need for…

01/28/2026 | Hannah Franco | O Liberal

https://www.oliberal.com/para/ministerio-da-saude-declara-surto-de-doenca-de-chagas-em-ananindeua-par%C3%A1-1.1077386#goog_rewarded 

The Ministry of Health has classified the increase in cases of Chagas disease registered in Ananindeua, in the Metropolitan Region of Belém, as an "outbreak." The change occurred after the confirmation of four deaths and approximately 14 cases linked to the disease in January of this year alone.

According to official data, the deaths registered this month already exceed the total number of deaths in the municipality over the last five years. The number of cases also shows significant growth and is 30% higher than that reported in the same period last year. Throughout 2025, Ananindeua recorded 45 cases of the disease, with 26 confirmed in December alone.

Investigation points to oral transmission of Chagas disease.
In a statement, the Ministry of Health classified the situation in Ananindeua as an "outbreak associated with oral transmission." Investigations are being conducted by teams from different agencies, including the Pará State Department of Public Health (Sespa), the National Health Surveillance Agency (Anvisa), and the Strategic Information Centers for Health Surveillance. According to the ministry, investigation, surveillance, assistance, and control actions are being carried out, including the evaluation of sanitary conditions in the food production and marketing chain. Treatment for the disease is offered free of charge by the Unified Health System (SUS). To reinforce these actions, the Ministry of Health has made available to the municipality a team from the Applied Epidemiology Training Program for SUS Services (EpiSUS), which can act as requested by…