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).

11/13/2025 | Guilherme Hummel | Health Business

https://www.saudebusiness.com/colunistas/medicos-e-hospitais-que-pesquisam-e-publicam-garantem-lugar-na-pos-medicina/ 

New legislation and AI are renewing research.

In 1976, psychiatrist and Columbia University professor Jerrold S. Maxmen published "The Post-Physician Era: Medicine in the 21st Century." Maxmen, who died in 1992, did not live to see his prophecy fulfilled: "In 50 years [2026], the traditional physician-centered healthcare model will be replaced by a new system that will depend less on individual doctors and more on computers and clinical technology." According to him, medical information would grow faster than the human capacity to assimilate it, making the figure of the "universal clinician" unfeasible. The book anticipated with remarkable precision some themes that would only gain traction decades later, such as electronic medical records, telemedicine, AI diagnoses, and the crisis of medical burnout caused by information overload. He projected a technological determinism that disregarded cultural and legal factors, and the importance of empathy in the doctor-patient relationship.

As we approach 2026, and with just over 3 years since the advent of remarkable Artificial Intelligences (GenAI), the medical profession faces an undeniable challenge: what does the future hold for the medical profession? It is certain that it will not disappear, but what will its core function be in the era of Post-medicine, in times of intelligent automation in medical practices?

Post-medicine should not be confused with neomedicine, or Xmedicine, or other opportunistic prudishness. She continues to care for patients as in the time of Hippocrates. But now she goes further, exceeding the act of diagnosing and…

11/13/2025  |   Kristina Lindgren  |  UCI Health

https://www.ucihealth.org/blog/2025/11/surviving-advanced-stomach-cancer 

In the fall of 2023, Mauricio Alvarez was given no more than a year to live after being diagnosed with advanced stomach cancer.

Two years later, he has beaten the odds thanks to a unique clinical trial developed by UCI Health gastric cancer specialists. Today, the 61-year-old mechanical engineer has no sign of the deadly disease.

Alvarez has a very good chance of extended, progression-free survival, says surgical oncologist Dr. Maheswari Senthil, co-principal investigator of the clinical trial with medical oncologist Dr. Farshid Dayyani at the UCI Health Chao Family Comprehensive Cancer Center.

"I wouldn't be here if it wasn't for Dr. Senthil and Dr. Dayyani," says the father of seven and grandfather of 10. “I want the world to know how great these doctors are. They are always looking to innovate, to find treatments that can help others."

Improving survival odds

Senthil and Dayyani launched the clinical trial called STOPGAP in 2020 to improve treatment options for patients like Alvarez with stage IV gastric cancer, which has a survival rate of six to 12 months even with the best systemic chemotherapy regimen available. Those poor results reflect the inability of the intravenous treatment (IV) to penetrate the abdomen's peritoneal lining.

Their multipronged approach combines systemic therapy with three months of chemotherapy delivered directly into the abdominal cavity through a peritoneal port. Next comes surgery to remove all visible tumors, bathing the area with a heated chemotherapy solution to kill any lingering microscopic cancer cells.

Armed with seed money from the UC Irvine Anti-Cancer Challenge, a cycling rally…

11/13/2025  |  Annabel Kartal Allen  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/geopolitical-instability-clinical-trials-oct-dach/ 

As unforeseen circumstances complicate clinical trial operations, companies in the space must be flexible to reduce the impact of these events.

The 2020s thus far have been fraught with unforeseen circumstances with pharmaceutical companies working through everything from a global pandemic to wars and supply chain uncertainty.

When operating clinical trials, geopolitical instability can pose significant challenges, so companies in the space must be well equipped to deal with these complexities both before and during an unforeseen event.

In a panel session at Arena International’s Outsourcing in Clinical Trials DACH 2025 conference, speakers noted that flexibility is key to mitigating the impacts of geopolitical instability.

Assessing MFN’s impact on pharma

Traditionally, the US has been a key market for the pharma industry, with high list prices for drugs meaning that the region accounts for a strong proportion of many companies’ global sales.

However, the US pharma landscape is shifting, as President Donald Trump’s re-election has seen a wide range of policies introduced that impact everything from drug pricing to import tariffs.

One of the most notable policies to come out of the Trump administration this year was the Most Favored Nation (MFN) executive order. Introduced in May 2025, the bill was signed to slash drug prices in the US, which have traditionally been significantly higher than in countries across Europe and Asia.

While MFN’s introduction has caused a stir in the pharma industry, Amir Ahari, global head of clinical studies, neuroscience…

11/13/2025  |  Yael L. Maxwell  |  TCTMD

https://www.tctmd.com/news/artificial-intelligence-successfully-adjudicates-clinical-events-cv-trials 

The hope is using AI to judge outcomes will ease the high cost and complexity of running big clinical trials, say researchers.

An artificial-intelligence (AI)-based model called Auto-MACE can adjudicate major adverse events in clinical trials, especially CV death and stroke, on par with expert physicians, according to new data.

The authors say their findings, presented this week at the American Heart Association 2025 Scientific Sessions and simultaneously published online in JACC, suggest that this technology could be used to streamline processes and save research dollars down the line.

“By decreasing the volume of cases requiring human review, AI can lessen a major driver of adjudication cost and timeline delays,” Pablo M. Marti-Castellote, PhD (Brigham and Women’s Hospital, Boston, MA), and colleagues write. “Applying a consistent AI-based adjudication model across all events within a trial and even between trials may improve reproducibility compared to adjudication by numerous reviewers with heterogeneous experience.

“AI has the potential to not only replicate human adjudication but actually improve upon its consistency and efficiency, paving the way for better clinical trials in the future,” they add.

Alexandra Popma, MD (Cardiovascular Research Foundation, New York, NY), who commented on the findings for TCTMD, said this “fantastic” study represents a formal step in the process of bringing AI into the fold of clinical trials.

“The challenge is how we are going to translate this into a product and an output that is going to be acceptable by regulatory agencies,”…

11/12/2025  |  Felix Sassmannshausen  |  Health Policy Watch

https://healthpolicy-watch.news/new-malaria-drug-candidate-exceeds-cure-rate-for-standard-acts-in-phase-3-trial/ 

The 97% cure rate for the novel compound, ganaplacide/lumefantrine in a recent Phase 3 trial offers hope for continued progress rolling back malaria even as resistance to artemisinin combination therapies (ACT) escalates. 

A next-generation antimalarial drug GanLum (ganaplacide/lumefantrine, KLU156) slightly outperformed a standard of care Artemisinin Combination Therapy (ACT) in a recent Phase 3 trial – offering new hope that recent gains against malaria can be maintained and advanced despite growing parasite resistance to current treatments.  

The randomised controlled trial (RCT) involving over 1,600 participants across 12 Sub-Saharan African Countries demonstrated a +97% cure rate for GanLum, as compared to 94% for the ACT, Coartem©, in the control arm of the trial, said the pharma firm Novartis. The results were published Wednesday following an embargoed briefing at the annual conference of the American Society for Tropical Medicine and Health (ASTMH) in Toronto, including Novartis co-developer, Medicines for Malaria Venture (MMV), lead trial coordinator, Abdoulaye Djimdé, and ASTMH President, David Fidock. 

The trial is all the more significant insofar as it tested efficacy against malaria caused by the most deadly parasite, Plasmodium falciparum (P. falciparum).

P. falciparum is responsible for almost all malaria-related deaths worldwide. African countries bear the heaviest burden, accounting for an estimated 95% of the 597,000 malaria-related deaths globally in 2023.

After falling dramatically from 2000 to 2015, malaria deaths and infections, which mainly…