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).

05/28/2026  |  WHO Media Team  |  WHO

https://www.who.int/news/item/28-05-2026-experts-convened-by-who-advise-on-candidate-treatments-and-vaccines-for-ebola-disease-caused-by-bundibugyo-virus

In response to the current outbreak of Ebola disease caused by Bundibugyo virus occurring in the Democratic Republic of the Congo, with cases also reported in Uganda, WHO convened several of its expert and advisory groups. These groups assessed potential vaccines and therapeutics for both prevention and treatment of Bundibugyo virus disease (BVD). The WHO advisory groups recommended that all the products identified and considered be used exclusively within clinical trials to generate robust data and ensure safe, ethical, and effective research.

WHO convened a series of meetings with the WHO R&D Blueprint technical advisory groups on candidate vaccines and therapeutics for BVD.

In parallel, WHO also convened the Strategic Advisory Group of Experts on Immunization (SAGE) and its Ebola vaccine working group to advise on the potential role of licensed Ebola vaccines during BVD outbreaks.

Key recommendations
There are currently no licensed therapeutics or vaccines specifically approved for the prevention and treatment of BVD. Nevertheless, WHO advisory groups considered several candidate products that are promising enough to warrant prioritization for evaluation in clinical trials. WHO is now working closely with the governments of the Democratic Republic of the Congo and Uganda to facilitate the implementation of research evaluation of these products.

For treatment of cases:

• For treatment, the independent experts recommended prioritizing three candidate therapeutics for evaluation in research (i.e.…

05/29/2026  |  Kerry Dooley Young  |  Medscape

https://portugues.medscape.com/viewarticle/placebo-vs-glp-1-dilema-%C3%A9tico-dos-ensaios-fase-3-2026a1000hyy?form=fpf 

Kailera Therapeutics is taking a somewhat unusual step in its effort to bring a new anti-obesity drug to market. One of its Phase 3 studies with ribupatide will test the dual agonist of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors not only against placebo but also against semaglutide (an already approved GLP-1 receptor agonist).

The pharmaceutical companies Eli Lilly & Co. and Novo Nordisk have also made comparisons with approved drugs in studies of experimental anti-obesity drugs.

However, an analysis by Medscape showed that, for the most part, Kailera, Eli Lilly, Novo Nordisk, and other pharmaceutical companies continue to test their experimental anti-obesity drugs only against placebo.

This strategy may raise practical and ethical questions for clinical trials, since most patients are aware of the efficacy of already approved GLP-1 receptor agonists.

Challenges of the placebo arm
The potential practical impact on clinical trials was mentioned by the authors of the study that supported the FDA’s approval, in April 2026, of orforglipron, a once-daily oral GLP-1 receptor agonist.

Dr. Sean Wharton, a physician, and his co-authors reported that 6.2% of patients in the placebo group discontinued treatment due to lack of efficacy, compared with up to 1% in the orforglipron group, depending on the drug dose. Other weight-control interventions were initiated by 2.5% of patients in the placebo group who remained in the study.

“Although the higher discontinuation rate in the placebo group in the present…

05/29/2026  |  Pistoia Alliance  |  News Medical Life Sciences

https://www.news-medical.net/news/20260529/Half-of-clinical-trial-professionals-cite-trust-and-regulatory-gaps-as-barrier-to-AI-adoption-Pistoia-Alliance-poll-finds.aspx 

The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has released new poll data showing trust and regulatory uncertainty are the biggest barriers to AI adoption in clinical trials, cited by half of respondents (50 %). The poll was conducted at the Clinical Trials Technology Congress (CTTC) in London, where the Alliance hosted a panel with regulators from the MHRA, Danish Medicines Agency and Swedish Medical Products Agency.

"A recurring message at the Congress was that regulators are ready to embrace AI, and are keen for pharma companies to engage early to ensure adoption is safe and compliant. The panel rightly emphasized that speed without control is not enough when patient safety is at stake. For AI to support clinical development at scale, the industry needs validated, auditable and explainable approaches, not black-box models that create uncertainty for sponsors and regulators alike. Regulators are not the enemy. They can be partners to pharma, working together to formalize AI guidance that supports both sides. This is exactly where the Pistoia Alliance helps, by convening pre-competitive working groups that bring pharma, technology providers and regulators together around common frameworks.”
Dr. Becky Upton, President, Pistoia Alliance

The poll data show that AI is beginning to deliver value in clinical development, with 42 % of respondents seeing early signs of Return on Investment (ROI) and…

05/29/2026  |  Jessica Davis Plüss  |  SwissInfo.ch

https://www.swissinfo.ch/eng/healthcare-innovation/ais-next-pharma-challenge-tackling-costly-and-risky-clinical-trials/91486864

AI has transformed the search for new medicines. Now drug companies are betting it can fix the slow, expensive process of testing them in humans.

Ask a pharmaceutical company about the current approach to clinical trials and you’re likely to hear a chorus of complaints about a broken and dysfunctional system. It takes on average at least a decade and roughlyExternal link $1-2 billion (CHF790 million-1.6 billion) to develop a new drug. Around 60-70% of that time is spent in the three phases of human testing. The longer a clinical trial takes, the longer it takes for that medicine to reach patients.

To make matters worse, companies often waste time and money on trials for drugs that aren’t ultimately approved by regulators. For every 100 drugs that begin human trials, about 90 aren’t given the green light because the tests fail to prove the medicines are safe or effective.

“The industry has just accepted that risk and failure are a part of drug development because there has been no other option,” said Kevin Buyens, co-founder and Chief Business Officer at AI biotech TwinEdge Bioscience in western Switzerland. “But this is changing. Digital technologies can help fill the gap.”

Artificial intelligence, especially machine-learning systems, have already helped scientists identify promising drug candidates by sifting through huge volumes of chemical and biological data far faster than humans.

The situation is different in clinical trials. Regulators like the US Food and Drug Administration (FDA) and Swissmedic use information…

05/28/2026 | Vilhena Soares | JOTA

https://www.jota.info/saude/anvisa-registra-alta-de-11-em-pesquisas-clinicas-em-2025 

The increase registered today does not reflect the effects of the new legislation, sanctioned in 2024, the agency says

The number of requests for clinical research in Brazilian centers increased 11% from 2024 to 2025, according to the Annual Report of Activities published by the National Health Surveillance Agency (Anvisa).

Despite its growth, the data indicate that the reliance mechanism — a simplified analysis based on the evaluations of international regulatory agencies — has been explored by less than two applicants.

Confirm, below, the highlights of Anvisa's report, analyzed by JOTA.

More orders
Anvisa received 352 doses of clinical trials last year, compared to 315 in 2024. The data still do not allow me to measure the impact of the new Clinical Research Law (Lei 14.874/2024), which is intended to speed up the agency's analysis.

"As the law was only regulated in October 2025, it is expected that future events, starting in 2026, will be able to demonstrate the practical effects of the rule," the document highlights.

Another relevant point of balance is the high rate of interruption of studies for the pharmaceutical industry. In 2025, there will be 30 cancellations and 62 withdrawals from clinical trials.

Among the cancellations, 33% occur due to "absence of benefit or benefit less than or expected." In relation to withdrawals, the most cited reason for companies was the “change of sponsor strategy”, which represented 42% of two recovery requests.

Read more... Read less... Open