[Notice - March 19, 2026]

NOTICE OF SCHEDULED MAINTENANCE – ReBEC

Please be advised that the ReBEC system will undergo a scheduled maintenance outage, beginning at 6:00 p.m. on March 20, 2026 (Friday) and expected to end at 6:00 p.m. on March 22, 2026 (Sunday).

During this period, the system will be unavailable for access and for performing any operations. This measure is necessary to implement improvements and updates aimed at ensuring greater stability, security, and performance of the platform.

We recommend that users plan ahead to avoid any potential disruptions to their activities.

Thank you for your understanding.
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).

04/06/2026  |  Moe Alsumidaie  |  The Clinical Trial Vanguard  -  Opinion

https://www.clinicaltrialvanguard.com/opinion/the-alzheimers-prevention-trial-has-no-finish-line-until-now/ 

Picture a regulatory affairs team at a mid-size biotech preparing its pre-IND package for a tau-targeting monoclonal antibody. The science is solid. The biomarker data from their Phase 1 are clean. But when they sit down to write the section on intended clinical benefit — the part where they define what success looks like in a prevention trial — the room goes quiet. Because nobody has formally defined what a preventive Alzheimer’s therapy needs to demonstrate to earn approval. Not in a way that translates directly into endpoint selection, trial duration, and enrollment criteria. They are building a finish line while running the race.

That is the operational reality that a new target product profile framework published in Nature Medicine in 2026 is trying to fix. The paper establishes explicit benchmarks for what treatments designed to delay or prevent symptomatic Alzheimer’s disease should achieve — covering efficacy thresholds, population definitions, safety tolerability, and biomarker utility. On its face, this sounds like academic housekeeping. It is not. For the sponsors currently designing trials in the pre-symptomatic and early symptomatic space, a validated TPP framework is the difference between a development program built on regulatory signal and one built on educated guessing.

But behind the framework’s careful language lies a quieter crisis — one that the paper itself cannot fully resolve, because it sits outside the agency’s direct authority. The FDA has guidance on early Alzheimer’s trials. It has expressed openness to biomarker-defined…

04/06/2026  |  Moe Alsumidaie  |  The Clinical Trial Vanguard  -  Opinion

https://www.clinicaltrialvanguard.com/opinion/the-alzheimers-prevention-trial-has-no-finish-line-until-now/ 

Picture a regulatory affairs team at a mid-size biotech preparing its pre-IND package for a tau-targeting monoclonal antibody. The science is solid. The biomarker data from their Phase 1 are clean. But when they sit down to write the section on intended clinical benefit — the part where they define what success looks like in a prevention trial — the room goes quiet. Because nobody has formally defined what a preventive Alzheimer’s therapy needs to demonstrate to earn approval. Not in a way that translates directly into endpoint selection, trial duration, and enrollment criteria. They are building a finish line while running the race.

That is the operational reality that a new target product profile framework published in Nature Medicine in 2026 is trying to fix. The paper establishes explicit benchmarks for what treatments designed to delay or prevent symptomatic Alzheimer’s disease should achieve — covering efficacy thresholds, population definitions, safety tolerability, and biomarker utility. On its face, this sounds like academic housekeeping. It is not. For the sponsors currently designing trials in the pre-symptomatic and early symptomatic space, a validated TPP framework is the difference between a development program built on regulatory signal and one built on educated guessing.

But behind the framework’s careful language lies a quieter crisis — one that the paper itself cannot fully resolve, because it sits outside the agency’s direct authority. The FDA has guidance on early Alzheimer’s trials. It has expressed openness to biomarker-defined…

04/06/2026  |  Pfizer

https://www.pfizer.com/news/articles/how_ai_is_already_reshaping_cancer_care 

When treating cancer, few things are more precious than time. Jeanine Bortel, Vice President and Head of AI Portfolio Development at Pfizer, who has developed clinical trials at Pfizer for more than two decades, remembers when she first witnessed the transformative potential of artificial intelligence (AI) put into practice to help address the needs of patients enrolled in cancer clinical trials.

For years, Bortel’s work had run up against an inherent challenge: Many cancer patients miss out on the opportunity to enroll in clinical trials. When someone is diagnosed with metastatic cancer, there’s often little time to sign up for a trial before a treatment plan must be determined. Missing that narrow window denies patients a “potentially life-changing opportunity to be part of a clinical trial,” Bortel says.

Thanks to rapid advances in AI, however, Bortel witnessed a turning point. Her “aha” moment, she recalls, occurred not long ago when she was managing team leaders for breast cancer trials. In the course of their research, machine learning—a type of AI that learns patterns from data it has access to—drastically improved their ability to predict who might be eligible for clinical trials and, in turn, offer them the chance to enroll before their window closed. Suddenly, these patients had access to treatment options that might have been inaccessible without AI.

“It unlocked a major opportunity,” says Bortel. “We have the ability to be transformative in how we identify patients who are likely to become eligible for a trial — something we simply couldn’t do before these new technologies.”

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