REBEC

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 and Traditional Communities – Clinical research and observational studies specifically designed for or preferably addressing traditional communities (quilombolas, caiçaras, faxinalenses, among others) and indigenous peoples, both within and outside legally demarcated territories, observing the specific regulations for each case.

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.

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).

News

10/03/2025

Potential Alzheimer’s treatment, trontinemab, hits the news – how does it work and is it available?

10/03/2025 | Emma Taylor | Alzheimer's Research UK

https://www.alzheimersresearchuk.org/news/potential-alzheimers-treatment-trontinemab-hits-the-news-how-does-it-work-and-is-it-available/

Three years ago, the results of a trial for lecanemab marked a turning point. They showed for the first time that Alzheimer’s disease can be slowed by medication. Not long after, another drug called donanemab followed with similar results.

In 2025, there are almost 140 drugs in clinical trials across the world. More than ever, there is hope that real change is coming – hope that people who develop dementia in the future won’t face the same realities as they sadly do today.

Some of that hope is resting on the results of what could be the second generation of Alzheimer’s treatments. In particular, a new drug called trontinemab has recently hit the headlines following some promising early results. But we won’t know for sure how well the drug works until at least 2028, when the current trial is due to end. Read on to find out if you could help scientists to find out whether this drug could be life-changing for people affected by dementia.

What is trontinemab?
Trontinemab is a potential new Alzheimer’s drug made by the pharmaceutical company Roche. It is still in development, with a trial due to start in autumn 2025.

Data from early phase trials suggests that this drug may target an underlying process in Alzheimer’s quickly and effectively.

However, we don’t yet know whether the drug will slow down symptoms getting worse. Until these data are released, we cannot say whether this drug could be effective in the treatment of Alzheimer’s disease.

How does trontinemab…

10/03/2025
Innovation in healthcare roundup: HCA Healthcare, the Allergy Centre of Excellence, Fujifilm and Optegra

10/03/2025 | Adrian Murdoch | Heathcare Today

https://healthcaretoday.com/article/innovation-in-healthcare-roundup-hca-healthcare-the-allergy-centre-of-excellence-fujifilm-and-optegra

The latest innovations in healthcare, including tumour-infiltrating lymphocyte therapy, allergies, cancer support and drop-free cataract treatment.
HCA Healthcare trials tumour-infiltrating lymphocyte therapy
US-owned private hospital operator HCA Healthcare will treat a metastatic lung cancer patient with tumour-infiltrating lymphocyte (TIL) therapy for the first time as part of a clinical trial at its research arm, Sarah Cannon Research Institute UK.

TIL therapy leverages the body’s own immune cells called tumour-infiltrating lymphocytes, which are naturally present within tumours and trained to target cancer cells. In February 2024, the Food and Drug Administration (FDA) approved TIL therapy as the first cellular therapy to treat solid tumours, initially for melanoma treatment under the name Lifileucel (Amtagvi).

At Sarah Cannon Research Institute UK, clinical trials are now exploring TIL therapy’s efficacy in advanced and metastatic non-small-cell lung cancer. The patient was referred from the NHS for participation in this groundbreaking clinical trial.

“TIL therapy represents a potential new treatment option for patients whose advanced cancer has become resistant to other therapies,” said Anja Williams, consultant medical oncologist at Sarah Cannon Research Institute UK. “By using the patient’s own immune cells that are already trained to target their specific cancer, we’re essentially harnessing and enhancing the power of their immune system to target the disease,” she continued.

First…

10/03/2025
How Government Shutdowns Set Back Clinical Trials

10/03/2025 | Denise N. Bronner | Clinical Leader

https://www.clinicalleader.com/doc/how-government-shutdowns-set-back-clinical-trials-0001

When the federal government shuts down, news coverage tends to spotlight furloughed workers, frozen paychecks, or the political drama playing out in Washington. What gets less attention is how these lapses stall the engine of scientific progress. For clinical research, even a brief shutdown can trigger cascading consequences: disrupted operations, wavering patient participation, delayed approvals, and setbacks for urgently needed therapeutics.

Clinical research thrives on continuity. It is built on tightly orchestrated timelines, fragile patient trust, and a steady flow of regulatory and financial resources. When that continuity is interrupted, the ripple effects extend far beyond missed deadlines. They reach the lives of patients who depend on trials for care and the future of therapies waiting to move from pipeline to practice.

Regulatory Bottlenecks & Uncertainty
The FDA sits at the center of clinical research, reviewing new drug applications, monitoring safety, and ensuring compliance. A shutdown leaves the agency with only a skeleton crew. Historically, about one-third of FDA staff have been furloughed during extended shutdowns, forcing the Agency to pause most routine operations. New drug and device submissions may be accepted, but reviews stall. Site inspections and audits, critical for moving programs forward, are postponed. And sponsors often find their regulatory queries met with silence.

These delays may seem procedural, but they create real-world consequences. A biotech preparing to launch a pivotal trial might suddenly find its timeline upended. A CRO monitoring multiple sites may have to cancel visits, raising questions…

10/01/2025
Enactment of Law No. 14,874 ushers in a new era of clinical research

09/29/2025 | Fernando de Rezende Francisco | Medicina S/A

https://medicinasa.com.br/sancao-lei-14-874-2024/

Brazil has begun a new chapter in Clinical Research with the enactment of Law No. 14,874/2024, which establishes a robust and modern regulatory framework in line with international best practices. More than just updating standards, the law creates conditions to expand the population's access to studies that bring innovation, new therapies, and a better quality of life.

Although the legislative process took almost a decade, the most recent stage of this process was marked by the leading role played by the Ministry of Health, through the Secretariat of Science, Technology, Innovation, and Health Complex (SECTICS) and the Department of Science and Technology (DECIT). In recent months, these areas have taken the lead on the agenda, competently and dialogically conducting the process that will culminate in the beginning of the regulation of the law and the reorganization of the ethical research system.

Despite its enormous potential, Brazil participates in just over 1% of global clinical studies, according to ClinicalTrials.gov. This means less investment, less access to cutting-edge technologies, and fewer opportunities for patients. Law No. 14,874/2024 paves the way for changing this scenario, and the recent actions of the Ministry of Health are decisive in consolidating these transformations.

The movement to draft a law for this area gained momentum in 2014 when Afonso Celso Haas, a businessman from Rio Grande do Sul diagnosed with advanced lung cancer, found a chance to prolong his life in a clinical trial. The experimental treatment not only gave him five additional years with his family, but also turned him into a symbol of the fight for the modernization of the sector.

Inspired by his story, doctors, lawmakers, organizations, and civil society…

10/01/2025
Law 14.874/24: a new perspective for clinical research in Brazil

10/01/2025 | Eurico Bitencourt Neto, Brunello Stancioli | Jota

https://www.jota.info/opiniao-e-analise/artigos/lei-14-874-24-uma-nova-perspectiva-para-a-pesquisa-clinica-no-brasil

Legislation is welcome and represents a bioethical and administrative milestone for Brazilian research

Improvements in the health, well-being, and productivity of contemporary societies are largely linked to advances in biomedical research and the improvements they bring to collective and individual health. In an era marked by exponential production of information and knowledge and, at the same time, by growing uncertainty and risk, biomedical sciences play a central role as a tool that saves lives and prevents disease in a world that still grapples with profound inequalities, thus serving as an important instrument of social justice.

In this context of undeniable relevance, the progress of biomedical research involves a double ethical challenge. On the one hand, preventing or hindering scientific research means hindering prophylaxis, cure, and prevention for countless diseases, hindering the achievement of better health conditions and adequate care for those facing various causes of suffering. On the other hand, clinical research involves the participation of volunteers who agree to subject themselves to certain risks in order for scientific progress to be achieved, which requires a protection system that ensures the preservation of their fundamental rights of personality.

Ensuring the ethics of research and the safety and interests of research participants is fundamental in this process, as they are the key to the tests that culminate in scientific advancement. However, until last year, Brazil offered very fragile legal guarantees to research participants.

Research ethics standards in Brazil…

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Public trial

Evaluation of the effects of Magnesium and Inositol Supplementation on sleep quality, Anxiety and quality of life of health students
Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Acupuncture on the control of nausea and vomiting in patients undergoing Bariatric Surgery in a private hospital in São Luís-Ma
Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Impact of different Materials on the gum of teeth with Lesions near the gums that are not caused by Caries
Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Analysis of the stability of Implants with different macrogeometries
Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Topical Metformin Effectiveness in Melasma Treatment
Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Study of the retinal structure in patients with Autism Spectrum Disorder
Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)
Last revision: 1
Study type: Observational

Clinical study to evaluate the efficacy and tolerability of the Meneguetti brush for self-collection of anal specimens to screen for anal cancer and sexually transmitted infections
Date of registration: 02/09/2023 ^(mm/dd/yyyy)
Last approval date : 10/02/2025 ^(mm/dd/yyyy)
Last revision: 2
Study type: Interventional

Total de Ensaios Clínicos 16964.

Existem 8361 ensaios clínicos registrados.

Existem 4703 ensaios clínicos recrutando.

Existem 251 ensaios clínicos em análise.

Existem 5769 ensaios clínicos em rascunho.

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