[Notice - March 19, 2026]

NOTICE OF SCHEDULED MAINTENANCE – ReBEC

Please be advised that the ReBEC system will undergo a scheduled maintenance outage, beginning at 6:00 p.m. on March 20, 2026 (Friday) and expected to end at 6:00 p.m. on March 22, 2026 (Sunday).

During this period, the system will be unavailable for access and for performing any operations. This measure is necessary to implement improvements and updates aimed at ensuring greater stability, security, and performance of the platform.

We recommend that users plan ahead to avoid any potential disruptions to their activities.

Thank you for your understanding.
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).

04/28/2026 | Anaeze C. Offodile II, Kushal T. Kadakia, Yashodhara Dash, Whitney Snider, Joseph C. Wu, and Selwyn M. Vickers | Harvard Business Review

https://hbr.org/2026/04/u-s-medical-centers-need-a-new-model-for-drug-discovery-and-development?language=pt 

For more than 50 years, academic medical centers (AMCs) in the United States have been the global engine of pharmaceutical innovation. These university-affiliated hospitals are dedicated to fulfilling the missions of medical education, scientific research, and patient care. They have developed a distinct innovation model in which patient care inspires research questions, public investment supports discoveries, and public-private partnerships enable the translation of these discoveries into clinical practice. But U.S. AMCs now face a major challenge from China, which has emerged as a significant rival in the last decade. Its pharmaceutical R&D sector is on track to become the global industry leader, replacing its North American counterpart.

To remain competitive, U.S. research contract management companies (AMCs) need to rethink their approach, and some have already begun to do so. This article explores what other companies can learn from these efforts—and what additional steps are needed for U.S. AMCs to remain at the forefront of drug discovery and development.

Previous Successes
Today, it is estimated that more than half of the patents behind drugs approved by the U.S. Food and Drug Administration (FDA) originate from research led by AMCs. Some examples of the many discoveries produced by this research ecosystem include the following:

• Fundamental discoveries about cholesterol metabolism at UT Southwestern, which later led to the development of statins.
• Translational research in cell signaling at several universities paved…

04/27/2026 | Medicina S/A

https://medicinasa.com.br/pesquisa-clinica-ia-edicao33/ 

Expert with over three decades in clinical development says Latin America could gain prominence in the next decade

The way new drugs are tested worldwide is set to undergo profound changes in the next decade. Advances in artificial intelligence, new regulatory requirements, and the pursuit of greater efficiency are transforming global clinical research, according to Charles Schmidt, a clinical development specialist with over three decades of experience in Latin America and global projects, and a professor at the Faculty of Medical Sciences of Santa Casa de São Paulo (FCMSCSP).

Reports from the pharmaceutical industry and clinical research organizations, such as Anvisa and Interfarma, point to a transition to more digitized and data-driven models. Thus, the next decade should represent a significant shift in how clinical studies are conducted worldwide.

“Clinical research has always evolved in cycles. We’ve already gone through regulatory crises, financial collapses, industry transformations, and even a pandemic that globally reconfigured operations. But the next decade looks structurally different,” he states.

According to the expert, sponsors—mainly large pharmaceutical and biotechnology companies—have begun demanding data quality, operational efficiency, and predictability from the very beginning of clinical studies.

The use of wearable devices for continuous patient monitoring, coupled with new regulatory frameworks and the advancement of study digitization, also contributes to this structural change in the sector.

In this scenario, research centers will need to demonstrate technological maturity, governance, and adaptability to remain competitive. Another factor that tends to transform the sector…

04/27/2026  |   Stacy R Lindborg  |  European Pharmaceutical Review

https://www.europeanpharmaceuticalreview.com/the-bayesian-edge-how-the-new-fda-guidance-is-enabling-nimble-efficient-clinical-trials/2135307.article 

Dr Stacy Lindborg, CEO of IMUNON, reflects on the FDA’s recent draft guidance that promotes the use of Bayesian modelling in clinical trials.

In recent years, the US Food & Drug Administration (FDA) has been on a mission to modernise its programmes, adding more flexibility to clinical trial designs and accommodating the complexities of indications such as cancer and rare diseases.

As part of the push, new draft guidance from the FDA1 was recently released on the use of Bayesian statistical methods in trials. As the guidance states, “Bayesian methods provide various applications in clinical trials. For example, Bayesian calculations can be used to govern the timing and adaptation rules for an interim analysis in an adaptive design, to inform design elements (eg, dose selection) for subsequent clinical trials, or to support primary inference in a trial.”1

The Bayesian method is hardly new. So why now? And what does this mean for clinical trial designs and sponsors looking to leverage the new opportunities?

Enabling a smart and efficient route
Bayesian modelling2 is a statistical approach that enables one to continuously update the probability of an outcome of interest as new information becomes available. Bayes’ theorem was posthumously published in 1763, but its application is more ubiquitous than ever in modern life. Google Maps navigation is a prime example: Bayesian inference powers the ‘smart’ real-time parts of Google Maps navigation, while…

04/27/2026  |  Mirage News

https://www.miragenews.com/clinical-trial-reforms-launched-1662533/ 

Patients in the UK to get access to new treatments faster and still safely under new clinical trial regulations coming into force on 28 April 2026.

The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) are introducing the largest package of reforms in over 20 years. This will include faster assessment of first in human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner and modification to be approved quicker, whilst maintaining the highest safety standards.

The reforms will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including use of early safety data from overseas studies which meets UK standards and computer model simulations which can help to predict how new medicines may behave before they are tested in patients.

The regulators have already made headway towards delivering more streamlined and efficient approvals, which has contributed to exceeding the government's ambitious target to reduce clinical trial set-up times to 150 days as part of its 10-year plan for the NHS. Latest figures show the contribution of the MHRA and HRA reducing set-up times from 169 days to just 122 days for studies going through combined safety and ethical review. The combined review process conducted by MHRA and HRA takes an average of 41 days, less than half of the time it took a few years ago.

This is good news for patients and researchers, enabling new trials to be set up more quickly and improving patient care. Innovations include the Route B substantial modification pathway which was successfully piloted from October 2025 to March 2026 and received strong support from…

04/27/2026  |  Ben Zimmer  |  Clinical Leader

https://www.clinicalleader.com/doc/breaking-barriers-in-rare-disease-clinical-trials-0001 

Conducting large-scale clinical trials in rare diseases presents a unique set of scientific and operational challenges. Dermatomyositis, a serious autoimmune condition affecting only an estimated five to 10 people per million each year, has historically been difficult to study at scale due to limited patient populations and complex disease management. To address this challenge, Priovant Therapeutics designed and executed the VALOR trial, which ultimately became the longest and largest interventional study ever conducted in dermatomyositis. VALOR’s results were recently published in the New England Journal of Medicine, where brepocitinib 30mg demonstrated statistically significant and clinically meaningful improvement over placebo on the primary endpoint and all nine key secondary endpoints, spanning global disease activity, muscle strength, skin involvement, physical function, and corticosteroid reduction.

Last month, the FDA granted Priority Review to brepocitinib’s New Drug Application, with a PDUFA target action date in the third quarter of 2026, underscoring both the urgency of the unmet need for a new standard of care that prioritizes rapid, sustained, steroid-sparing efficacy and the potential for this therapy to meaningfully shift the treatment paradigm in dermatomyositis. Delivering a trial of this magnitude required careful study design, deep collaboration with physicians and patient communities, and sustained operational focus.

Executing A Global Trial In An Ultra-Rare Disease
Enrolling and executing a rare disease trial like VALOR is challenging across so many dimensions. It’s difficult to enumerate every single one of these,…