About ReBEC

The Brazilian Clinical Trials Registry (ReBEC) is an open-access virtual platform for registering experimental and non-experimental studies involving human beings 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 (PAHO), and the Oswaldo Cruz Foundation (FIOCRUZ). The Executive Committee of ReBEC is composed of the aforementioned institutions and the National Health Surveillance Agency (ANVISA). ReBEC is an important source of information for patients, healthcare professionals, researchers, companies, and research centers. Its support services feature generative artificial intelligence ReBEC@, the first artificial intelligence for clinical trial registration in the world. Learn more

Everything you need to know about ReBEC

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Instructions for the Registrant

We recommend reading the Registrant's Manual.

1 - Register or log in and fill out the forms normally in Portuguese and English.
For English, if you experience any difficulty, use Google Translate
(or another free translation tool).
2 - Attach the mandatory ethics committee documentation and submit the form.
3 - Save the support number in your WhatsApp contacts. Send a message with your name and username.
It is not necessary or recommended to send your password. 
4 - A reviewer will respond to you. Choose your preferred communication mode:
chat, audio recordings, or scheduled voice call.
5 - Your form will be reviewed in both languages. Follow further instructions to complete approval.

Clinical Research Volunteer

Would you like to become a volunteer in a clinical trial registered in ReBEC?

Access our FAQ to find out how.

08/31/2026 | Priscila Torres | BioRed Brasil

https://www.bioredbrasil.com.br/diretoria-da-anvisa-delibera-sobre-pesquisa-clinica-boas-praticas-de-fabricacao-composicao-de-vacinas-contra-covid-19-rotulagem-e-controle-de-substancias/ 

On July 8, 2026, the Brazilian Health Regulatory Agency (Anvisa) held the 12th Public Ordinary Meeting of its Collegiate Board (DICOL). The session was led by CEO Leandro Pinheiro Safatle and attended by directors Daniel Pereira, Daniela Marreco, Tiago Campos, and Marcelo Moreira, as well as Chief Counsel Flávia Oliveira Tavares, Ombudsman Samara Carneiro, and Secretary-General Kenia Hugo Lucas.

The agenda included twelve items for deliberation covering pharmacovigilance, Good Manufacturing Practices (GMP), drug and food labeling, clinical research, pharmacopeia, vaccines, and substance control.

Summary
Eleven items were unanimously approved during the meeting. A key highlight for pharmaceutical sector stakeholders was the amendment to RDC 497/2021. This amendment establishes priority processing for Good Manufacturing Practices Certification (CBPF) applications linked to registration or post-registration processes that are currently under review or nearing completion, thereby fostering greater integration between certification and registration workflows and reducing operational bottlenecks. Along these lines, a normative instruction was approved to improve the continuous data submission process for Drug Clinical Development Dossiers (DDCM), allowing sponsors to present information progressively as it becomes available, thereby directly accelerating the review of clinical research. The composition of COVID-19 vaccines was updated, retaining the LP8.1 strain as the preferred antigen—or…

08/31/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/sponsors-cros-must-address-growing-execution-translation-gap-tufts-study-finds 

Research shows pharma companies identify clinical trial risks well but lack the organizational capability to implement effective solutions.

Sponsors and CROs are effective at detecting problems with trials, but they are less adept at taking corrective action, according to new analysis.

Research by the Tufts Center for the Study of Drug Development suggests this “execution translation gap” reflects a breakdown in organizational capability that is having a detrimental impact on clinical trials.

“This gap reflects the systemic inability to convert well-identified problems into coordinated, timely, and effective action. In a domain as complex and interdependent as clinical trials, this gap manifests in the failure to mobilize cross-functional teams, align incentives, adapt processes, and implement corrective strategies and tactics.

“The execution translation gap is not a deficit of knowledge; rather, it is a failure to execute clinical activities efficiently and effectively. Its consequences are measurable, material, and growing,” authors Kenneth Getz and Kenneth Kaitin wrote.

Protocol deviations are an example of these consequences, according to the authors, who pointed to a 56% increase in the mean number of deviations per trial over the past five years—up from 189 in 2020 to 296 last year—to support their argument.

“This trend suggests that root causes are not being effectively addressed. Instead, corrective actions are localized and transient, failing to achieve systemic learning,” they wrote.

Enrollment…

09/01/2026  |  Brian Maguire/Jennifer Carroll MacNeill  |  Euractive

https://www.euractiv.com/news/irelands-clinical-trials-council-meets-for-first-time/ 

A new advisory council chaired by Professor Donal Brennan will steer a 20-point reform plan, aiming to lift trial numbers before a national trials body launches in 2027

Ireland has advanced its overhaul of clinical research, with the Clinical Trials Advisory Council (CTAC) convening for the first time on 27 August. Health minister Jennifer Carroll MacNeill welcomed the meeting on Monday, calling it another milestone in reshaping the country’s trials landscape.

The council draws together patient representatives, healthcare providers, academics, industry, regulators and government agencies. It will provide strategic advice and oversight as Ireland implements reforms set out in the National Clinical Trials Oversight Group’s (NCTOG) final report, published last November.

The report had recommended the council be in place by early 2026; it convened for the first time some months later.

“Transforming the clinical trials landscape in Ireland is a priority for Government,” Carroll MacNeill said. She praised a “broad and balanced membership” spanning patients, clinicians, researchers, regulators, industry and the state, describing collaboration as essential to delivering the recommendations.

Professor Donal Brennan, who chairs the council, said he was “honoured to be in a position to continue this vital work”, pledging to drive implementation of the blueprint and “deliver meaningful improvements for patients, researchers and the wider health system”.

The council fulfils a recommendation of that report, Transforming Ireland’s Clinical Trials Landscape: A Blueprint…

08/31/2026  |   Christina Elston/Cedars-Sinai  |  New Wise

https://www.newswise.com/articles/study-supplement-plus-chemo-boosts-pancreatic-cancer-survival 

Adding an FDA-Approved Version of the Common Dietary Supplement Glutamine to Standard Therapy Improved Outcomes in Patients With Advanced Disease, Prompting Further Clinical Trials

When added to standard chemotherapy, a clinical version of the dietary supplement L-glutamine improved survival in an early-phase trial of patients with advanced pancreatic cancer. The study, led by Cedars-Sinai Health Sciences University investigators, was published in Nature Cancer.

L-glutamine, an amino acid that occurs naturally in the body and plays an important role in digestion, has been studied as a potential way to ease side effects in other cancers. But this was the first trial to evaluate it as an anti-cancer therapy in human patients, said Jun Gong, MD, associate professor of Medicine, medical director of Colorectal Cancer at Cedars-Sinai Cancer and first author of the study.

“Current treatment for stage 4 pancreatic cancer is a cocktail of chemotherapy, with overall survival ranging from eight to 13 months,” Gong said. “We found that by adding L-glutamine to this treatment, we increased overall survival to as much as 22 months—and these positive results merit larger clinical trials of this combination.”

In this Phase I clinical trial, investigators studied 16 patients with advanced pancreatic cancer. All patients were treated with a standard chemotherapy combination of gemcitabine and nab-paclitaxel, along with clinical-grade L-glutamine supplements.

“We began the trial in the hope of improving gut health in these patients,” said Neil Bhowmick, PhD, Mark Goodson Chair in Oncology Research,…

08/31/2026  |  Jon Napitupulu  |  The Clinical Trial Vanguard

https://www.clinicaltrialvanguard.com/news/ascletis-doses-first-patient-in-asc30-phase-iii-obesity-trial/ 

With roughly 4,600 participants, two pivotal trials, and a regulatory clock that runs through late 2028, Ascletis has placed a substantial bet that the obesity pill market will be far more crowded and competitive by the time ASC30 reaches an FDA reviewer’s desk. The company announced this week that the first participant has been dosed in AURORA-1 and AURORA-2, its global Phase III program for the once-daily oral small molecule GLP-1 receptor agonist ASC30. That timing matters because oral semaglutide for weight management already cleared the FDA in December 2025, and Ascletis itself acknowledges ASC30 is positioned to become the second oral small molecule GLP-1 receptor agonist available in the U.S. and Europe, if approved. Entering a market against an established oral incumbent is a meaningfully different competitive posture than entering against injectables alone.

The trial architecture is straightforward but demanding. AURORA-1 enrolls adults with obesity or overweight without type 2 diabetes; AURORA-2 targets the same BMI thresholds in patients who have type 2 diabetes. Both are 72-week, randomized, double-blind, placebo-controlled studies testing three maintenance doses (20 mg, 40 mg, and 60 mg), with percentage change in body weight from baseline as the primary endpoint in each. Sites span the U.S., Europe, and Canada. Topline data are expected in the third quarter of 2028, with an NDA submission targeted by year-end 2028 and an EMA marketing authorization application to follow in early 2029. Ascletis states its current cash position funds operations into 2029, covering both planned regulatory submissions without an intervening…