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).

06/15/2026 | AL1

https://al1.com.br/noticias/noticias/197862-pesquisa-clinica-acesso-a-tratamentos-e-potencial-do-brasil-colocam-setor-no-centro-do-debate-em-saude 

Clinical research has gained prominence in Brazil not only for its role in advancing science, but mainly for its direct impact on the lives of patients who find in clinical studies a real opportunity to access innovative treatments, often unavailable through traditional means.

In Brazil, this scenario takes on even greater relevance. The country possesses strategic characteristics that position it as one of the most promising markets for the development of clinical research in the world, such as ethnic diversity, a qualified medical staff, and research centers with recognized experience.

Clinical research plays a fundamental role not only in the development of new drugs, therapies, and vaccines, but also as a concrete alternative for patients facing serious or rare diseases who have exhausted the options available in the healthcare system.

“For many patients, clinical research represents the possibility of accessing treatments that are not yet commercially available. In many cases, it is a real chance to improve quality of life and even extend survival,” emphasizes Fernando de Rezende Francisco, executive director of the Brazilian Association of Representative Organizations of Clinical Research (ABRACRO).

In addition to the direct impact on the patient journey, the sector also drives the economy, generates qualified jobs, and strengthens the health innovation ecosystem. Even so, Brazil faces structural challenges that impact its competitiveness, such as regulatory deadlines and processes that could be more agile, especially in an increasingly dynamic international landscape.

06/15/2026 | Band.com

https://www.band.com.br/noticias/canal-livre/ultimas/avanco-em-pesquisa-clinica-aproxima-medicina-do-brasil-do-padrao-global-202606141702#google_vignette 

Oncologists discuss cultural differences in treatment between Brazil and the United States and highlight the expansion of scientific studies in the SUS (Brazilian Public Health System)

The quality of centers of excellence in private medicine in Brazil is on par with the main health services in the United States, but the clinical research landscape still establishes a significant distance between the two countries. Oncologist Antonio Buzardi, who worked for 13 years in American institutions, including Yale and Emerson universities, states in an interview with Canal Livre that the American territory remains light-years ahead in the development of new treatments, driven by investments that exceed global rates. Despite the disparity in the volume of resources, Brazil is showing structural progress in conducting international protocols.

The Instituto Vencer o Câncer (Cancer Victory Institute), co-founded by Buzardi and fellow oncologist Fernando Maluf, leads the expansion of the national scientific field with the creation of 20 research centers installed in hospitals of the Unified Health System (SUS) located in vulnerable regions of the country.

This initiative allows patients from locations such as Manaus to access clinical studies integrated with universities and hospitals of global prestige, such as Harvard, Memorial New York, and MD Anderson in Texas.

Cultural Differences and the Impact of Research on the SUS
The relationship between doctors and patients exposes striking cultural contrasts in daily hospital life. While the North American…

06/16/2026  |   WANG XIAOYU  |  China Daily.com

https://www.chinadaily.com.cn/a/202606/16/WS6a30a4f8a310986e2b460298.html 

Revised guideline ensures compliance with ethics, protection of participants

China has recently released a new edition of the Good Clinical Practice for Drugs — a guideline designed to ensure the ethical and scientific conduct of clinical studies, aiming to strengthen the nation's research ecosystem and support innovation in biotechnology.

The document, jointly issued by the National Medical Products Administration and three other government departments last week, is an update of the version that has been in effect since 2020. The new version is set to take effect on Sept 1.

According to the administration, key highlights of the guideline include the addition of provisions on data governance, as well as an emphasis on compliance with ethical principles, scientific rules, and relevant laws and regulations when applying new technologies and methods.

The guideline states that data governance should run throughout the entire clinical trial process, ensuring accurate reporting, validation, and interpretation of trial-related information.

Researchers are also required to establish procedures to guarantee the reliability, traceability, and security of electronic data, and to prevent data loss or tampering.

The guideline explicitly identifies the principal investigator as the responsible person at the site level and names the sponsor as the ultimate accountable party for all trial-related activities.

Sponsors are also required to consider the protection of participants' rights and safety as of fundamental importance when carrying out trials.

To further enhance the protection of participants, the guideline calls for strengthened ethics review…

06/15/2026  |  Gareth Macdonald  |  BioXconomy

https://www.bioxconomy.com/clinical-and-research/ema-prepares-for-major-clinical-trial-regulation-changes-under-eu-biotech-act-coming-this-year 

The agency will allocate resources to update systems before new rules take effect, aiming to speed assessments and cut administrative burden for sponsors.

The EU Biotech Act will result in “significant changes” to the Clinical Trial Regulation and Clinical Trials Information System, according to the European Medicines Agency (EMA).

The Amsterdam-based regulator made the comments this week, explaining its management board will allocate resources to prepare for these changes before the Biotech Act comes into full effect.

An EMA spokesperson told BioXconomy, “In December 2025, the European Commission proposed the Biotech Act. This aims to modernize the regulatory framework and, through more agile regulation, strengthen the EU’s competitiveness in research and development. 

“Building on what has already worked well under the Clinical Trials Regulation, the Biotech Act proposes amendments to support high-quality science, reduce administrative burden, and ultimately improve patients’ access to innovative treatments,” she added.

In addition to facilitating faster trial assessments, the Act will modify the CTR to give sponsors and CROs greater flexibility when it comes to adjusting ongoing studies, the spokesperson said. It will also prompt an update of the CTIS, the public database where sponsors log information about drug research.

Related:EMA proposes contract platform to aid sponsors, sites, and CROs

“The implementation of the Biotech Act will be supported by enhanced…

06/15/2026  |  Catherine Longworth  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/ai/clinical-trial-statistics-gets-an-ai-era-overhaul/?cf-view

For decades, statistical analysis has remained one of clinical research's most manual processes. As AI reshapes drug development, CROs and sponsors are asking whether biostatistics could be the next major efficiency breakthrough. 

or much of the pharmaceutical industry’s discussion around artificial intelligence (AI), attention has focused on drug discovery. Yet as sponsors race to shorten development timelines, another area of the clinical trial ecosystem is emerging as a candidate for technological disruption: biostatistics.

Despite decades of advances in data capture and trial management, many of the processes underpinning statistical analysis remain heavily reliant on manual programming, bespoke workflows, and labour-intensive quality control.

For an industry under increasing pressure to accelerate development timelines while maintaining regulatory compliance, the question is becoming harder to ignore: why are some of clinical research’s most critical workflows still operating much as they did decades ago?

That is the challenge that Veristat is attempting to address through InStat, an AI-enabled biostatistics platform designed to automate elements of statistical analysis and reporting while preserving the traceability required by regulators.

“We’ve been writing, checking and executing thousands of lines of study-specific code by hand for decades,” Kyle McBride, Vice President of AI and Innovation at Veristat tells Clinical Trials Arena. “At some point you have to ask: there’s got to be a better way to do this.”

A legacy process meets modern…