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 and Traditional Communities – Clinical research and observational studies specifically designed for or preferably addressing traditional communities (quilombolas, caiçaras, faxinalenses, among others) and indigenous peoples, both within and outside legally demarcated territories, observing the specific regulations for each case.

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.

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).

10/13/2025  |  Sapna Rani  |  Clinical Leader

https://www.clinicalleader.com/doc/trends-in-rare-disease-trials-trial-designs-challenges-and-regulatory-progress-0001 

A rare disease, as defined by the World Health Organization, affects fewer than one person in every 1,000, and the cumulative burden is enormous, with more than 7,000 distinct conditions identified to date. Despite this, 95% of rare diseases lack FDA- or EMA-approved treatments. Patients typically face years-long journeys to diagnosis, fragmented expertise, and limited access to research trials. Pediatric prevalence is high; around half of rare disease patients are children, making ethical and logistical trial design a particularly complex challenge.1

The rare disease clinical trial ecosystem is rapidly evolving in response to scientific, operational, and regulatory complexities. A shift from classical randomized controlled trials (RCTs) to innovative, flexible model including micro trials, adaptive designs, registry-based studies, and n-of-1 approaches reflects both the constraints and the opportunities inherent in studying small, heterogeneous patient populations. Regulatory authorities have responded with progressive frameworks, incentives, and methodological flexibility. This article reviews the evolution of trial design types in rare disease research, analyzes ongoing challenges, and examines how regulatory support is enabling innovation, preparing for a follow-up discussion on how sponsors can match trial design to research needs and emerging solutions.

Rare diseases, though individually infrequent, collectively affect more than 300 million people worldwide. Clinical research for these diseases is confounded by ultra-small patient populations, diagnostic uncertainty, and a lack of natural history data or robust…

10/13/2025  |  Mark Chiang  |  Gene Online

https://www.geneonline.com/ai-in-clinical-trials-focuses-on-predictive-analytics-and-patient-recruitment-optimization/ 

A recent analysis highlights the potential and challenges of artificial intelligence (AI) in clinical trial technology, emphasizing the importance of focusing on tangible outcomes rather than being swayed by emerging trends. Industry experts stress that while AI offers promising advancements in drug development, its implementation must prioritize measurable results to ensure meaningful innovation.

The report underscores the need for executives in pharmaceutical and biotech sectors to approach AI-driven tools with a critical perspective. It notes that enthusiasm for cutting-edge technologies should not overshadow their ability to deliver practical benefits in streamlining clinical trials or improving drug efficacy evaluations. The findings suggest that while AI has demonstrated capabilities such as predictive analytics, patient recruitment optimization, and data processing efficiency, its success ultimately depends on how effectively these tools translate into improved outcomes for patients and stakeholders.

10/13/2025  |  Liz Wells  |  Healthcare Management

https://www.healthcare-management.uk/winds-change 

Stakeholders and policymakers came together at the start of October to discuss priorities for medicine regulation in the UK

Westminster Health Forum held its latest event on 2 October to examine the priorities for medicine regulation in the UK.

The webinar, attended by more the 70 delegates, heard from Dr Karen Noble, director of research policy and innovation for Brain Tumour Research. She told delegates that the UK needs a better user-friendly registry or a finder for clinical trials to support clinicians. 

She said: ‘It's very difficult for the clinicians to know what's going on and, therefore, is even more challenging for the patients to be able to understand what clinical trials might be relevant for them.

However, Dr Noble told delegates there is ‘some sunshine' on the horizon. Scott Arthur has taken his Rare Cancers Bill, which aims to improve outcomes for patients with cancers that affect less than one in 2,000 people, through the House of Commons and now to the House of Lords. He wants to set up a national specialty lead and dedicated registries to improve trial access for patients.

She told the webinar that the UK needs to improve processes, from taking tissue to making it, making sure it is stored appropriately, and then making sure that the genome sequencing is happening in a timely and speedy manner, and that there are enough staff to be able to interpret those results. 

Jane Morrin O'Rourke, senior policy manager at Health Research Authority (HRA), gave delegates some background on the work the organisation has been involved in to improve the future of clinical research delivery. This work is known as the UK Clinical Research Delivery Programme and also…

10/13/2025  |  Paul J. Hastings  |  STAT10

https://www.statnews.com/2025/10/13/clinical-trials-autoimmune-disorders-crohns-lupus-nkarta/ 

My teenage years were ravaged by severe autoimmune disease. In that era, the burdens of treatment for Crohn’s disease rivaled the misery of the affliction.

My illness brought searing stomach pain, fatigue, and fistulas. The steroids my physician prescribed caused breakouts of cystic acne all over my body as well as exhausting bouts of hyperactivity, manic mood swings, and a serious case of moon face. 

Hopelessly trapped between symptoms and side effects, I would have jumped at the chance to participate in a clinical trial. Instead, faced with an impossible choice of excruciating pain vs. mania, lethargy, and disfigurement, I opted for an eight-hour surgical intervention. 

Forty-six years later, I’m still managing my autoimmune disease, but I’m also a CEO of a biotech company focused on delivering a new kind of cell therapy for people with autoimmune conditions. While biologics transformed what’s possible for people living with Crohn’s, millions of autoimmune patients still manage the side effects, risks, and tradeoffs of lifelong immunosuppressive steroids. 

As a teenager, I rarely talked about my condition. For so long, stoicism has been the default posture of so many people living with severe, yet often invisible autoimmune diseases. We’re a community that has been taught to cope, not hope. But recently, thanks to biotechnology innovation, what’s medically possible may be changing.

In 2022, a German researcher named Georg Schett showed the world that cell therapy could put a subset of young adult lupus patients into prolonged drug-free remission after conducting a small clinical trial.…

10/10/2025  |  Nicholas Shores  |  Veja Magazine  

https://veja.abril.com.br/coluna/radar/lei-de-pesquisa-clinica-atraira-investimentos-diz-industria-farmaceutica/ 

FarmaBrasil Group expects regulation to double the number of clinical studies in Brazil and propel Brazil into the top 10 in the global ranking for this field 

The FarmaBrasil Group, an association representing twelve of the leading national pharmaceutical companies, believes that the Clinical Research Law, regulated by President Lula this week, represents a “strategic boost” to attract more investment in innovation and position Brazil among the leading countries in this area.

Brazil currently ranks 20th in the global ranking of clinical studies, behind countries with smaller GDPs and pharmaceutical markets, such as Taiwan and Egypt. 

Last year, Brazil conducted 254 clinical studies. The expectation with the regulation is to double that number and place the country among the top ten nations in the global ranking in this segment. 

“Brazil brings together ethnic diversity, a robust consumer market, and highly qualified health researchers,” says Reginaldo Arcuri, CEO of FarmaBrasil. 

“The new law provides an adequate legal framework that encourages research and values knowledge, so that studies are conducted with respect and efficiency,” he adds.