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).

07/16/2026  |  Hilde Vanaken  |  Applied Clinical Trials

https://www.appliedclinicaltrialsonline.com/view/making-communications-resonate-wherever-people-own-words  

The traditional global-to-local communication model creates fragmented content through sequential adaptation, but a local-first approach using structured data and AI-orchestrated generation can embed stakeholder terminology and preferences from the start, reducing rework while improving clarity and relevance.

Communication is often underestimated. It is not just about sharing information—it is about ensuring that what is intended is actually understood. When that alignment breaks, people don’t just miss details; they fill gaps with assumptions. In regulated environments, those assumptions can translate directly into operational inefficiencies, quality risks, and potential impacts on patient safety.

In clinical research, the importance of clear communication is amplified. Trials bring together a diverse network of stakeholders—participants, investigators, site staff, ethics committees, health authorities, and sponsor teams—each with different expertise, expectations, and perspectives. Information must simultaneously meet scientific rigor and be understandable in plain language, often across multiple cultures and languages. Ensuring that meaning is preserved—rather than lost—across that complexity is far from trivial.

This challenge is intensifying. Clinical trials are becoming more complex. They incorporate digital tools and artificial intelligence into already intricate workflows—introducing concepts that can be difficult to fully grasp, even for highly trained professionals.1 This raises a critical question: if even experts need time to interpret and understand…

07/16/2026  |   Eva Lorenz  |  POZ

https://www.poz.com/article/common-misunderstandings-clinical-trials 

A Patient Advocacy Foundation survey reveals knowledge gaps about clinical trials, barriers to participation and possible solutions.

Findings from a survey conducted by the nonprofit Patient Advocate Foundation revealed cancer patients’ knowledge gaps and misperceptions about clinical trials. The findings also shed light on some of the common barriers that prevent cancer patients from joining clinical trials. While practical barriers, such as time, location and insurance concerns, were common, trust and safety mattered too.

The Patient Advocate Foundation helps patients with chronic, life-threatening illnesses navigate and access the complex healthcare system, including through financial assistance and patient education. The foundation also offers clinical trial resources and helps patients find clinical trials through its TrialFinder.

“People are open to participation [in clinical trials], but they need clearer information, stronger guidance from their providers and fewer practical barriers. This represents a meaningful opportunity. Improving education could help clarify how trials work, particularly around concepts such as randomization and the role of physicians,” wrote the report’s authors.

The researchers highlight four key takeaways from the survey findings:

• Understanding of clinical trials is uneven and often uncertain.
• Misconceptions about physician roles are common.
• Barriers are primarily practical—like cost and transportation—but trust and safety matter too.
• Willingness to participate is high if barriers are addressed.

Clinical trials play a vital role in many aspects of our fight against cancer. Not…

07/16/2026  |  Andy Studna  |  Applied Clinical Trials

https://www.appliedclinicaltrialsonline.com/view/study-quantifies-financial-return-risk-based-quality-management-oncology-trials

New peer-reviewed research combining real-world RBQM data with Tufts CSDD benchmarks finds ROI multiples as high as 23x, with time savings identified as the primary driver of financial value.

A peer-reviewed study co-authored by researchers from CluePoints and the Tufts Center for the Study of Drug Development (Tufts CSDD) has produced quantitative evidence on the financial value of risk-based quality management in clinical development.1

The paper, published in Therapeutic Innovation & Regulatory Science, addresses a long-standing gap: while risk-based quality management (RBQM) has gained increasing acceptance as an operational framework aligned with ICH E6(R3), quantitative evidence on its financial impact has been limited.

The analysis combined real-world RBQM data from 18 oncology trials conducted on the CluePoints platform with published and proprietary oncology benchmarks maintained by Tufts CSDD.

Two primary financial measures were modeled: clinical trial-level ROI based on direct financial returns from monitoring-cost efficiencies and shorter trial durations, and development-program-level ROI based on risk-adjusted financial value across the broader oncology development pathway.

Key findings
RBQM-enabled trials were associated with 8% to 19% reductions in clinical phase durations. At the clinical trial level, estimated financial returns ranged from $3.2 million in Phase I to $18.9 million in Phase III, corresponding to ROI multiples of 6x to 23x. At the development-program level, expected net present value gains ranged from…

07/16/2026  |  Mary Whitfill Roeloffs  |  Forbes

https://www.forbes.com/sites/maryroeloffs/2026/07/16/kalshi-opens-betting-market-for-pharmaceutical-trials-and-fda-decisions/ 

Online gambling website Kalshi has already accepted more than $100,000 worth of bets in a new suite of prediction markets launched Thursday that allows people to gamble on the outcome of pharmaceutical clinical trials and when—or if—a drug will be approved by the federal Food and Drug Administration.

Key Facts
Kalshi launched the new markets Thursday in partnership with AppliedXL, which monitors and predicts the outcomes of clinical trials, and people are now able to place bets on more than a dozen different pharmaceutical outcomes.

The market only allows people to bet on the outcomes of Phase 3 trials run by established biopharma companies and on full approval decisions by the FDA—not on early-stage trials or conditional approvals, but it could expand the market down the line.

For now, most of the available bets focus on late-stage trials run by larger companies with market caps of at least $500 million, like Gilead Sciences (one market asks if the FDA will approve Gilead's experimental cancer drug anito-cel by the end of the year).

Other bets include if an Alzheimer's drug developed ‌byAriBio will meet the goals of its late-stage clinical trial, when Eli Lilly's new weight loss drug retatrutide will get FDA approval and if the FDA will approve a cure for Type 1 diabetes before 2033 (56% of bettors say no).

Kalshi requires employment verification for traders and says it will restrict the markets only to people without insider information (a policy that has failed before), but researchers have said they're…

07/16/2026  |  Gaya Gupta  |  The Guardian

https://www.theguardian.com/technology/2026/jul/16/kalshi-betting-drug-trial-results 

Move comes as prediction platforms rapidly gain popularity and offer opportunities to bet on virtually anything

Kalshi is expanding its wagers to include bets on drug trial results, an expansion into new predictions territory as platforms continue to rapidly gain popularity and offer opportunities to bet on virtually anything.

The betting platform said the expansion into clinical trials and FDA regulatory decisions would help surface information on drug trials that otherwise go unreported. A publicly listed contract on a drug trial would produce a “continuously updated, public probability that reflects the weight of the evidence, rather than the preferred message of the trial sponsor”, the company said.

“Drug development is one of the most important and most information-constrained industries on earth,” Kalshi’s CEO, Tarek Mansour, said in a statement. “The data that determines which drugs advance and which don’t is largely locked away from the people who need it most. Surfacing information is what Kalshi is for, and we are committed to doing it right: compliance-first, carefully scoped, and built for the long term.”

The launch is described as a pilot program, and was announced as a partnership with the artificial intelligence firm AppliedXL.

Critics have said prediction platforms such as Kalshi are at risk of market manipulation and insider trading.

Federal regulators told CBS News on Friday that Donald Trump’s longtime teleprompter operator made tens of thousands of dollars on bets around the president’s speeches. Last month, the Department of Justice launched an investigation into…