[Notice - March 6, 2026]

Dear researchers,

In the last 24 hours, instabilities were identified on the ReBEC platform in some operations in the registration form.

Our Information Technology team has already carried out the necessary adjustments.

There was no leak, loss, or alteration of the stored data.

We appreciate your understanding.

Sincerely,
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).

03/09/2026  |   Liz Highleyman  |  Cancer Health

https://www.cancerhealth.com/article/power-participation-cancer-clinical-trials

Clinical trials offer access to cutting-edge treatment and the opportunity to help others while helping yourself.

The remarkable advances in cancer CARE AND treatment are largely attributable to the countless patients who have chosen to take part in clinical trials over the years. Participating in studies can be a good way to gain early access to the newest therapies, contribute to science and help other people living with cancer. But it’s important to weigh the pros and cons.

Despite the benefits, less than 10% of adult cancer patients in the United States participate in treatment trials, and groups such as Black and Latino people, those with lower incomes and rural residents are underrepresented.

“How precise can medicine be when the data showing whether a drug works or not excludes entire populations?” asked Yehoda Martei, MD, a medical oncologist at the University of Pennsylvania, in a recent STAT opinion piece. “Our failure to enroll truly representative populations in clinical trials not only harms patients, it threatens the foundations of innovation and undermines the promise of personalized medicine.”

The most familiar clinical trials assess the safety and effectiveness of new therapies in a formalized, stepwise manner (see “Clinical Trial Stages,” below). The process of developing new medications is lengthy and expensive, and only a small fraction ever make it from the laboratory to pharmacy shelves. Many drug candidates that show promising activity in a test tube or a mouse don’t end up working in humans—but the only way to know is to try.

The gold standard for testing new therapies is…

03/09/2026  |  Abigail Beaney  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/features/opening-clinical-trials-to-pregnant-women/ 

Research found just 4% of trials over the past decade allowed the inclusion of pregnant women.

regnant and breastfeeding women have historically been excluded from medical research, resulting in substantial gaps in evidence on the safety and efficacy of medicines and vaccines.

Analysis led by the Global Observatory on Health Research and Development of all clinical trials in the International Clinical Trials Registry Platform (ICTRP) reveals that just 4% of clinical trials over the past decade allowed the inclusion of pregnant women. As a result, many pregnant and breastfeeding women are left without treatment options or take prescription medicines off-label, without adequate data to inform safe use.

In response, the World Health Organization (WHO) established a global task force to tackle this, with the aim of achieving timely and ethical inclusion of pregnant and breastfeeding women in clinical research for medical health products by 2030.

This is not just a task for agencies like WHO to take on, however, says Sheila Diamond, digital health strategist at Medidata, and is something that all parties involved in clinical trials need to address to improve access.

Abigail Beaney (AB): Why are women so underrepresented in clinical trials?
Shelia Diamond (SD): With my work in Medidata and as a board-certified genetic counsellor, I have seen firsthand how these healthcare disparities widen as medicine becomes more advanced. As we move to an era of precision medicine, it holds such incredible promise, but without including these populations across the board, we can’t necessarily innovate in the way we need to…

03/09/2026  |   Leila Cupersmith  |  Clinical Leader

https://www.clinicalleader.com/doc/the-fda-plausible-mechanism-framework-just-changed-rare-disease-drug-development-0001 

If you lead clinical development at a pharmaceutical, biotech, or biopharma company working in rare or ultra-rare disease, you know the operational reality. Patient populations are extraordinarily small. Diagnoses arrive late — sometimes years after disease onset. Designing a randomized controlled trial for a disease affecting fewer than a dozen patients worldwide has always been, for many programs, both scientifically impractical and ethically out of reach. Randomizing fewer than a dozen known patients worldwide to placebo or non–disease-modifying care is ethically out of reach because it can deny a potentially life-altering therapy to a meaningful fraction of the entire patient population — often children with progressive, irreversible disease — without a proportionate social or scientific benefit. For many of these ultra-rare diseases, every day that passes can translate to permanent loss of function, decreased quality and duration of life.

On February 23, 2026, the FDA released the Plausible Mechanism Framework to establish, for the first time, a formal approval pathway for individualized therapies targeting ultra-rare genetic diseases, including genome editing technologies, such as CRISPR, and RNA-based therapies such as antisense oligonucleotides (ASOs).

This is a structural shift in how approval evidence can be generated and evaluated for programs where conventional clinical trial design does not apply. Every rare and ultra-rare disease sponsor needs to understand it and prepare to take immediate action. Traditional randomized controlled trial frameworks were never designed for…

03/06/2026  |  Millie Hoe  |  BioXconomy

https://www.bioxconomy.com/modalities/peptide-therapeutics-market-set-soar-investments-clinical-trials-rise 

The US is driving innovation in the peptide therapeutics space, especially around GLP-1s.

Investment in peptide therapies is set to soar in the next decade. A recent financial report from Grand View Research predicts a market value of almost $300 billion by 2033, more than double their 2025 evaluation of $140 billion. The US currently dominates the peptide space at more than 60% of the market share. 

What appears to be driving this growth is the stratospheric success of glucagon-like peptides (GLP-1s). These have fueled clinical trial investments to discover additional indications for GLP-1s while spotlighting the abilities of other peptide drugs. 

From uses in oncology to the treatment of rare diseases, peptide popularity is attracting significant investor attention.

More than weight loss
Much of the focus on GLP-1s has been on weight loss, with the World Health Organization (WHO) releasing guidelines recommending their use for the “long-term management” of obesity. While this will certainly generate significant capital within the peptide therapies market, multiple studies have highlighted that GLP-1s aren’t just a one-trick pony.
A landmark study published in the Journal of the American Medical Association (JAMA) evaluated data from over 58,000 patients with type II diabetes, heart failure, and obesity. The study found a 42% risk reduction of death or hospitalization from heart failure in patients treated with GLP-1s compared to the placebo group. What’s more, there was nearly double the incidence of hospitalization and death in patients treated…

03/05/2026  |  Jacob Becraft  |  Washington Post/Opinion

https://www.washingtonpost.com/opinions/2026/03/05/offshore-china-clinical-trials-biotechnology/ 

A burdensome regulatory environment is pushing clinical trials overseas.

In the late 20th century, the United States made a bet that it could offshore manufacturing to countries with cheaper labor, such as China, while leading innovations at home. But although that bet delivered cheaper goods, it also hollowed out domestic manufacturing capacity, weakened supply chains, cost millions of jobs, and fueled the rise of foreign competitors who now rival or surpass American industry.

Today, the U.S. is making the same mistake with biotechnology.

More companies are running clinical trials in China, where early-stage medical research is faster and cheaper. From 2010 to 2021, the number of clinical trials conducted in China by Western companies more than tripled, and by 2023 China was registering roughly 50 percent more interventional clinical trials than the U.S. This shift is often justified by the view that it doesn’t matter where drugs are first tested, so long as Americans eventually gain access to them.

After more than a decade working in genetic medicine, I believe this view is deeply flawed. Early clinical development is not interchangeable, low-value work. Where trials are run determines where expertise accumulates, where data are generated and where the next generation of therapies is conceived. Forfeiting this stage of innovation to China threatens American science and national security.

But offshoring early-stage innovation isn’t inevitable. With one targeted change to clinical trial approval policies, the U.S. could reverse this trend, making new medicines cheaper and more accessible for Americans.