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, 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).

News

06/23/2026

Anvisa Cancels Six Clinical Trials at the Request of Companies

06/23/2026 | Wallace Graciano | O Tempo

https://www.otempo.com.br/politica/2026/6/23/anvisa-cancela-seis-pesquisas-clinicas-a-pedido-de-empresas

The Brazilian Health Regulatory Agency (Anvisa) has officially withdrawn six applications related to clinical trials of drugs in Brazil. The decision was published via Resolution RE 2,503, dated June 22, 2026, in Monday’s edition of the Federal Official Gazette (DOU).

The measures respond to requests made by the manufacturers themselves, who decided to halt the progress of their applications with the federal agency’s Coordination of Clinical Research on Medicines and Biological Products. Among the affected companies are the pharmaceutical firms EMS, Apsen, and Janssen-Cilag.

In practice, the resolution means that studies for the development of new synthetic drugs or modifications to products already under investigation have been shelved. Since the research was still in the administrative review or technical execution phase, there is no direct impact or risk to those who already use drugs from these brands in the domestic market.

List of Canceled Applications
O TEMPO’s investigation found that the measure covers the following approval applications (official authorization to conduct research) and dossiers:

EMS S/A — approval application for a Drug Clinical Development Dossier (DDCM) for a synthetic drug and approval application for a clinical research protocol for synthetic drugs.
Apsen Farmacêutica S/A — three approval applications for Drug Clinical Development Dossiers (DDCM) for synthetic drugs.
Janssen-Cilag Farmacêutica Ltda — application for modification of the product under investigation in a clinical trial.

What…

06/22/2026
Promising single-dose malaria treatment advances toward pan-African clinical trial

06/22/2026 | Dr. Nicola Wittekindt | DZIF

https://idw-online.de/de/news873085

Researchers at the German Center for Infection Research (DZIF) have developed a promising single-dose malaria treatment that could help address growing drug resistance and simplify treatment for patients. The four-drug combination treatment, known as SPAP, is now being prepared for large-scale clinical testing across Africa. Prof. Ghyslain Mombo-Ngoma, who was named to the 2026 TIME100 Health list in recognition of his contributions to global health research, is co-leading the project.

Despite major progress in recent decades, malaria continues to cause hundreds of thousands of deaths every year, primarily in sub-Saharan Africa. Drug resistance is increasing, and many patients struggle to complete treatment regimens that require medication over several days. While new antimalarial drugs are being developed, it may take years before they become widely available.

To address these challenges, researchers supported by DZIF are investigating how to combine existing medicines more effectively. They have developed SPAP, a new single-dose combination therapy based on the four already approved antimalarial drugs, sulfadoxine, pyrimethamine, artesunate and pyronaridine.

Results from a clinical trial conducted in Gabon suggest that SPAP could significantly improve malaria treatment. By targeting the malaria parasite through multiple mechanisms, SPAP has the potential to overcome two major barriers to malaria control: increasing drug resistance and poor adherence to multi-day treatment schedules.

"Efforts are underway to develop next-generation antimalarial medicines, but it will take many years for them to reach the market," explains Prof. Peter Kremsner, a world-renowned malaria researcher at University Hospital Tübingen, regarding the objective of the study. "It…

06/22/2026
New drug could double survival time in patients with advanced pancreatic cancer

06/22/2026 | News Medical Life Sciences by Cedars-Sinai

https://www.news-medical.net/news/20260622/New-drug-could-double-survival-time-in-patients-with-advanced-pancreatic-cancer.aspx

A new medication could double survival time in patients with advanced pancreatic cancer, according to Phase III clinical trial results presented at the American Society of Clinical Oncology (ASCO) 2026 annual meeting and simultaneously published in The New England Journal of Medicine.

Andrew Hendifar, MD, professor of Medicine and medical director of the Cancer Clinical Trials Office and the Gastrointestinal Oncology Disease Research Group at Cedars-Sinai, was a principal investigator on the trial and a co-author of the study, which was sponsored by Revolution Medicines, makers of the new drug. He sat down with the Cedars-Sinai Newsroom to talk about the study results.

How does this new drug work?
The medication, called daraxonrasib, is the first drug that targets cancer-causing mutations in pancreas cells.

The drug targets a mutation in the KRAS gene, part of the RAS genetic family. KRAS mutations are present in 92% of pancreatic cancers. KRAS genes normally act as an "on-off" switch for cell growth. Mutated KRAS genes are stuck in the "on" position and send out a signal that causes cells to divide and grow uncontrollably, allowing cancer to form.

Daraxonrasib blocks the KRAS signal by fitting into a keyhole-type spot on the gene. That spot has a complex shape and is difficult to reach within the cell. The drug gets around this problem by using a "passenger protein" as a Trojan horse. When the cell allows this protein in, daraxonrasib tags along.

Why are these clinical trial results so groundbreaking?
…

06/22/2026
What Sponsors Don't See: The Systems Behind Clinical Trial Delivery

06/22/2026 | Jim Kremidas | Clinical Leader

https://www.clinicalleader.com/doc/what-sponsors-don-t-see-the-systems-behind-clinical-trial-delivery-0001

Ask any sponsor what they need from a site network, and they'll tell you quality, speed, consistency, and predictability. Ask them how they assess whether a network can deliver those things, and the answer is usually a feasibility questionnaire, an investigator's resume, and prior enrollment history.

It's a pretty thin basis to judge the quality of a trial by, and it sits oddly against the reality of what site operations actually look like in a modern multisite clinical research corporation (MCRC). MCRCs are networks of sites specializing exclusively in clinical trial delivery, with centralized functions, standardized processes, and technology infrastructure that generate detailed operational data across every active study. Most of it never reaches sponsors, because the systems sponsors deploy aren't connected to the platforms sites use.

Two Systems, One Trial
The technology stack within an MCRC is built around the operational realities of running trials at scale and generates substantial performance data.

Sponsors see almost none of it. For each study, they deploy their own EDC, IRT, and eCOA platforms, none of which connect to site-owned infrastructure. Site staff end up entering much of the same data twice, and the operational picture that could fundamentally change how sponsors plan and manage trials is rarely, if ever, surfaced.

Table 1: The MCRC Operating System

06/22/2026
China's annual clinical trial registrations top 5,000 for first time

06/22/2026 | Wang Xiaoyu | chinadaily.com.cn

https://www.chinadaily.com.cn/a/202606/22/WS6a3905e9a310986e2b4613df.html

The annual number of clinical trials registered in China surpassed 5,000 for the first time in 2025, doubling the figure recorded in 2020, according to a report released on Monday by the National Medical Products Administration.

The report, published by the NMPA's Center for Drug Evaluation, showed that the number of international multicenter clinical trials reached 410 in 2025, nearly double the 2020 level.

Of the more than 5,000 clinical trials registered last year, 57.5 percent were conducted for new drugs, totaling 2,997 trials and marking an 18 percent year-on-year increase. The remainder consisted of bioequivalence studies designed to evaluate the performance of generic drugs.

Clinical trials involving cell and gene therapies continued to rise significantly, with oncology remaining the dominant therapeutic area. Meanwhile, the number of trials for rare disease drugs, medical imaging and radiopharmaceuticals, as well as studies of new drugs in pediatric populations, remained relatively stable.

Chinese drug regulators have also prioritized accelerating the entire clinical trial process to speed patient access to high-quality medicines.

In 2025, the average time from regulatory approval to trial initiation for new drugs was shortened by four months compared with the previous year. In addition, a record-high 74.2 percent of trials obtained informed consent from the first participant within six months of approval.

According to the administration, 248 new drugs were approved for market entry in 2025, spanning 18 therapeutic areas, including oncology, endocrinology and mental disorders.

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Public trial

Use of Elastic Bandages to reduce pain and swelling in the lower limbs of pregnant women
Date of registration: 06/23/2026 ^(mm/dd/yyyy)
Last approval date : 06/23/2026 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Comparison of different skin rejuvenation treatments associated with cosmetic products
Date of registration: 06/22/2026 ^(mm/dd/yyyy)
Last approval date : 06/22/2026 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

The benefits of Intermittent Pneumatic Compression Boots for muscle soreness, strength and performance
Date of registration: 03/30/2026 ^(mm/dd/yyyy)
Last approval date : 06/22/2026 ^(mm/dd/yyyy)
Last revision: 2
Study type: Interventional

How the use of dentures may influence taste and smell in older adults
Date of registration: 06/22/2026 ^(mm/dd/yyyy)
Last approval date : 06/22/2026 ^(mm/dd/yyyy)
Last revision: 1
Study type: Observational

Energy expenditure of healthy men during walking in water and on land
Date of registration: 06/22/2026 ^(mm/dd/yyyy)
Last approval date : 06/22/2026 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Randomized Clinical Trial - Auricular Vagal Electrical Stimulation (aVNS) for the immediate postpartum period
Date of registration: 06/22/2026 ^(mm/dd/yyyy)
Last approval date : 06/22/2026 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

How does the information source influence what parents and guardians think about fluoride in dental caries prevention?
Date of registration: 06/22/2026 ^(mm/dd/yyyy)
Last approval date : 06/22/2026 ^(mm/dd/yyyy)
Last revision: 1
Study type: Interventional

Total de Ensaios Clínicos 18460.

Existem 9368 ensaios clínicos registrados.

Existem 5100 ensaios clínicos recrutando.

Existem 110 ensaios clínicos em análise.

Existem 6155 ensaios clínicos em rascunho.

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