[Notice - March 6, 2026]

Dear researchers,

In the last 24 hours, instabilities were identified on the ReBEC platform in some operations in the registration form.

Our Information Technology team has already carried out the necessary adjustments.

There was no leak, loss, or alteration of the stored data.

We appreciate your understanding.

Sincerely,
ReBEC Coordination

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).

03/11/2026 | Ana Luiza Figueiredo | Olhar Digital

https://olhardigital.com.br/2026/03/11/ciencia-e-espaco/por-que-estudo-da-polilaminina-ainda-nao-foi-publicado/ 

Article on polylaminin faces criticism from scientific journals due to data discrepancies and lack of prior registration of the clinical trial

The research on polylaminin, a substance studied for the treatment of spinal cord injuries, has not yet been accepted by scientific journals. The work was released in 2024 as a preprint, a preliminary version that has not yet undergone the formal peer review process.

The author of the study, Tatiana Sampaio, stated in an interview with g1 that the article will be revised to correct points criticized during the publication attempts. According to the researcher, the new version should correct errors identified in the manuscript and clarify aspects questioned by editors and specialists.

Why did some scientific journals reject publication?

When a scientific article is submitted to a specialized journal, it goes through a peer review process, in which other researchers evaluate the methodology, results, and conclusions of the study. Approval indicates that the work has undergone a technical analysis considered one of the main quality filters in science.

According to Tatiana Sampaio, the revised version of the article received rejections from three journals, including Nature Communications, another journal in the Nature group, and the Journal of Neurosurgery. Among the reasons cited by the editors are disagreements about the recovery rate used as a reference in the study and the absence of prior registration of the clinical trial in an international research database.

Disagreements in the recovery rate

In the study, the authors…

03/11/2026  |  EurekaAlert! por Fundação de Amparo à Pesquisa do Estado de São Paulo

https://www.eurekalert.org/news-releases/1119674 

Study published in Nature Medicine confirms that Butantan-DV protects against hospitalizations.

The tetravalent dengue vaccine, developed by the Butantan Institute in São Paulo, Brazil, with support from FAPESP, was 80.5% effective against severe dengue cases with warning signs over a five-year period. The results of the phase 3 clinical trial were published on March 4 in Nature Medicine.

Funded by the Brazilian Ministry of Health, the Brazilian Development Bank (BNDES), and the Butantan Foundation, the study was conducted at 16 research centers across Brazil’s five regions. From February 2016 to July 2019, 16,235 participants between the ages of 2 and 59 were recruited. Of those, 10,259 received a single dose of the vaccine, while 5,976 received a placebo.

There were no reports of hospitalization in the vaccinated group, compared to eight cases in the placebo group.

Overall, the vaccine was 65% effective in preventing symptomatic dengue (caused by any serotype) during the five years of monitoring.

The vaccine, called Butantan-DV, was approved by the Brazilian Health Regulatory Agency (ANVISA) on November 26, 2025, for use by the Brazilian population aged 12 to 59. Since then, the institute has sent 1.3 million doses to the National Immunization Program (PNI), which distributes them to Brazil’s national public health network, the SUS (Sistema Único de Saúde).

In January of this year, the Ministry of Health began a pilot project to immunize 90% of the target population in Nova Lima (Minas Gerais state), Maranguape (Ceará state), and Botucatu (São Paulo state). The vaccination of primary care health professionals…

03/11/2026  |  Manasi Vaidya  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/features/be-nimble-be-ready-how-to-tackle-regulatory-uncertainty-in-clinical-trials/ 

Rich Pelt, senior director of Global Regulatory Sciences at Pfizer gives tips for navigating the rapidly changing regulatory space.

A constantly evolving landscape for clinical trials and drug development research has created challenges for the sector to not only keep up with changes but also to plan ahead for potential developments.

Recent changes in guidelines for trials issued by the US Food and Drug Administration (FDA) have necessitated contract research organisations (CROs), pharma sponsors, biotechs and clinical investigators to adapt quickly to ensure a successful program.

Rich Pelt, senior director of Global Regulatory Sciences at Pfizer, shared insights at the Outsourcing Clinical Trials (OCT) Southeast conference, on lessons learned from navigating the regulatory uncertainty of the last few years in pharma and clinical trials space.

In a conversation with Clinical Trials Arena, Pelt discusses the current landscape for clinical research, recent controversies surrounding vaccines, and how to plan effectively for new possibilities.

The OCT Southeast conference is taking place 10–11 March in Raleigh, North Carolina.

Manasi Vaidya (MV): How can sponsors and other stakeholders in the clinical trials space weather ongoing changes at the FDA, the Department of Health and Human Services (HHS) and other agencies? What have you found helpful?
Rich Pelt (RP): To some extent, the best way to be helpful is to be resilient, because there is no a clear magic pill for any of this stuff right now. Be nimble, be ready and just…

03/06/2026  |   Jyoti Madhusoodanan  |  Nature

https://www.nature.com/articles/d41586-026-00526-8

Disaggregating data by sex is a powerful way to help develop better diagnostics and treatments for women — but researchers say it’s not used enough.

As a postdoctoral researcher, Jennifer Rabin spent her days studying how risk factors for heart disease corresponded to the chance of developing Alzheimer’s disease. In 2019, shortly after she started her own laboratory at the University of Toronto, Canada, she met with a PhD student who wanted to study women’s health. Together, they began to explore whether an obvious sex difference, the drop in the hormone oestradiol during the menopause transition, might be connected to higher rates of Alzheimer’s in women. Rabin was astounded by the research literature — or rather, its scarcity. “I just couldn’t believe how little we know,” she says.

The student’s project was a turning point for Rabin. Over the next few years, she realized that across many conditions, women’s health was uncharted scientific…

03/11/2026  |  Moe Alsumidaie  |  The Clinical Trial Vanguard

https://www.clinicaltrialvanguard.com/opinion/how-a-single-egfr-change-is-exposing-the-clinical-trial-industrys-embedded-patient-bias-problem/ 

A single algorithmic correction — removing one variable from one equation — is now demonstrably responsible for thousands of Black patients gaining access to kidney transplants they were previously denied. If that doesn’t reframe how the clinical trial industry thinks about the tools embedded in its own infrastructure, nothing will.

According to STAT News, removing race as a variable from the estimated glomerular filtration rate (eGFR) calculation — the standard measure used to assess kidney function — produced a 5.3 increase in transplants per 1,000 Black candidates. That is a structural correction to a system that was actively and measurably disadvantaging patients based on a biological assumption with no sound scientific foundation. The race-adjusted eGFR had been artificially inflating kidney function estimates for Black patients, making them appear healthier than they were, and therefore less urgently in need of a transplant. The algorithm wasn’t neutral. It was a gatekeeping mechanism dressed in clinical clothing.

The implications for clinical trials are the story. Because the same class of algorithmic thinking — race-adjusted, historically derived, assumption-embedded — is woven throughout the trial ecosystem. It lives in the eligibility criteria. It lives in biomarker stratification. It lives in the composite endpoints that define whether a drug works. And almost nobody is auditing it.

The Problem Is Structural, Not Incidental
The eGFR case is not an isolated failure. The…