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).

06/01/2026 | HU Brazil Network | Gov.br

https://www.gov.br/hubrasil/pt-br/hospitais-universitarios/regiao-centro-oeste/humap-ufms/comunicacao/noticias/ebserh/primeiro-biobanco-publico-de-celulas-tronco-da-rede-hu-brasil-functurara-no-humap-ufms-1 

Service opens the way for innovation in regenerative medicine and advanced therapies within SUS 

The Maria Aparecida Pedrossian University Hospital, of the Federal University of Mato Grosso do Sul (Humap-UFMS), linked to HU Brasil, receives approval from the National Research Ethics Commission (Conep) for the operation of the mesenchymal stem cell biobank (CTM). Com isso, this unit will first be a public bank of samples of these types of cells, with a regulated flow of availability for research projects approved by the Committees of Ethics in Research with Human Beings.

According to Thais Farias, technical biologist in charge of the biobank and chef of the Humap Research Management Unit-UFMS, CTM is only cells that do not have a specific function, but can be found in specialized tissues, such as fat, umbilical cord, and dental pulp. leite. “They have the capacity to transform into other cells when they affect a healthy tissue, in addition to regulating the immune system in the areas of inflammation,” he explains.

Cells with regenerative potential

Due to these two characteristics reported by the biologist, CTM has potential for use in regenerative medicine and in the treatment of various diseases, such as arthritis, diabetes and neurological diseases. In addition to stem cells, the biobank also stores blood, serum and plasma samples, which broaden the scope of research for different areas of scientific knowledge.…

06/01/2026 | Paola Caracciolo | HU Brazil/MS Network | Gov.br

https://www.gov.br/hubrasil/pt-br/comunicacao/noticias/pesquisa-do-hospital-da-rede-hu-brasil-em-niteroi-rj-destaca-substancias-biologicas-como-fator-de-propensao-a-doencas-cardiovasculares 

Biomarkers such as GDF-15 provide information for diagnosis and prognosis

Biomarkers are substances found in our blood or urine that can be used for the diagnosis of diseases. Researcher Humberto Villacorta (aside), professor of cardiology at Universidade Federal Fluminense and doctor at Hospital Universitário Antônio Pedro (Huap-UFF), reports on a line of studies that investigates the biomarker GDF-15 (Growth Differentiation Factor 15) as indicative of cardiovascular alterations.

"At the bottom of the line is the area of ​​heart failure, which is a situation in which the heart grows and increases in size, often causes symptoms such as lack of heart and swelling in the legs. And within the heart doenças I study cardiac biomarkers, which contain substances that "People do not bleed or urine, and we provide information for diagnoses and prognoses, or seja, establish the risk of death or hospitalization of a certain condition," explains the researcher.

Humberto Villacorta says that among the most common biomarkers found in blood are natriuretic peptides (BNP and NT-proBNP) and troponins. Therefore, more recently, the growth factor of differentiation, or GDF-15, is gaining prominence in research around the world. GDF-15 is a cytokine, a protective cellular component, which has an anti-inflammatory function.

"We know that when the GDF-15 biomarker is high, it indicates a worse prognosis, but in some situations it can…

06/01/2026  |  Huntsman Cancer Institute at the University of Utah  |  News Wise

https://www.newswise.com/articles/clinical-trial-shows-novel-prostate-cancer-treatment-can-reduce-risk-of-disease-progression-by-half 

A Phase 3 clinical trial led by Neeraj Agarwal, MD, FASCO, senior director of clinical research at Huntsman Cancer Institute and professor of internal medicine at the University of Utah (the U), has found that a combination prostate cancer treatment could prevent the disease from progressing into a harder-to-treat form of cancer in select patients.

The study, TALAPRO-3 (NCT04821622), evaluated a combination of two drugs—talazoparib and enzalutamide—in patients with metastatic castration-sensitive prostate cancer. This is a form of the disease that has spread beyond the prostate but remains susceptible to standard hormone therapy treatment. The patients involved also had prostate cancer affected by certain gene mutations, including but not limited to BRCA1 and BRCA2 mutations, that often signal more aggressive disease.

Agarwal and his research team assessed enzalutamide in combination with talazoparib in comparison to enzalutamide alone, the standard of care. Using the two drugs together led to an observed 52% reduction in the risk of disease progression or death. 

The results of the trial have been published in the prestigious New England Journal of Medicine. Agarwal also presented these findings as a late-breaking abstract at the American Society of Clinical Oncology Annual Meeting.

“Delaying progression to castration-resistant disease, when hormone therapy will no longer work, remains a significant challenge in patients with an earlier stage of metastatic prostate cancer, also known as castration-sensitive prostate…

06/01/2026  |  Mary L. Hendrickson/Emily K. Weber  |  Foley

https://www.foley.com/insights/publications/2026/06/clinical-trial-transparency-enforcement-a-practical-guide-for-sponsors-and-research-sites-after-fdas-april-2026-reminders/ 

On April 13, 2026, the U.S. Food & Drug Administration (FDA) publicly disclosed that it had sent targeted reminder messages on March 30, 2026, to more than 2,200 sponsors and researchers concerning over 3,000 registered clinical trials that appear to lack required results postings on ClinicalTrials.gov. The agency’s internal review indicated that nearly 30 percent of studies considered “highly likely” to be subject to mandatory reporting obligations still have no results available to the public. Former but then-current FDA Commissioner Marty Makary emphasized that the failure to report results distorts the scientific record by over-representing positive outcomes while concealing negative or inconclusive findings — a situation the agency views as a direct threat to public health and informed decision-making by patients, physicians, and regulators.

These reminders stem from long-standing statutory and regulatory requirements under Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), codified at Public Health Service Act § 402(j) and FDA’s 2016 Final Rule implementing that provision (42 C.F.R. Part 11). In general, “applicable clinical trials” must have results submitted to ClinicalTrials.gov no later than one year after the trial’s primary completion date. The obligations apply regardless of whether the product ultimately receives marketing approval, and they extend to both positive and negative outcomes.

Although…

06/01/2026  |   Kerry Cullinan  |  Health Policy Watch

https://healthpolicy-watch.news/three-eboba-vaccine-candidates-fast-tracked/ 

Three investigational vaccine candidates for the Ebola Bundibugyo virus are being “urgently accelerated towards clinical trials”, the Coalition for Epidemic Preparedness Innovations (CEPI) announced on Monday.

There are no licensed vaccines for the Bundibugyo virus, and none are in clinical development. This is the strain of Ebola currently driving the outbreak in the Democratic Republic of Congo (DRC) and Uganda, with over 1000 suspected cases and 246 deaths.

CEPI will invest up to $62 million “to back a portfolio of candidates under development from longstanding partners with proven capabilities”.

These include candidates developed by IAVI, Moderna, and the University of Oxford, which will be manufactured at the Serum Institute of India.

IAVI has been awarded $3.2m to accelerate the development of a recombinant vesicular stomatitis virus (rVSV)-based vaccine candidate.

The candidate was developed by University of Texas Medical Branch (UTMB) scientist Dr Thomas Geisbert and colleagues, building on earlier work by Andrea Marzi and Heinz Feldmann from the National Institute for Allergy and Infectious Diseases in the United States.

IAVI has reached an agreement with UTMB to develop the rVSV candidate, which has “demonstrated protective efficacy in nonhuman primate studies but has not yet been evaluated in humans”, IAVI noted in a statement on Monday, adding that the Dutch government is assisting in financing the vaccine development.

World Health Organization (WHO) experts determined last week that IAVI’s one-dose rVSV vaccine candidate is the most promising Bundibugyo vaccine candidate in the pipeline and called for it…