01/13/2026  |  Salong Debbarma  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/uk-clinical-trial-regulatory-reforms/ 

The new rules introduce a fast-track notification route, enabling quicker starts for lower-risk trials and maintaining safety standards.

The UK has announced new clinical trial regulatory reforms to boost its appeal as a leading destination for medical research.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) reported a 9% increase in clinical trial applications between January and November 2025 compared to the same period in 2024, with notable growth in early-stage and innovative studies.

Early phase research saw the strongest gains, with trials involving healthy volunteers rising by 16%, first-in-human studies up by 5%, and initial UK-based trials increasing by 7%. The MHRA also experienced a 75% surge in scientific advice meetings as companies sought earlier guidance to optimise trial design and minimise delays.

These increases occurred under the current framework, but significant regulatory changes are set for April. The new rules will introduce a fast-track notification route for around one in five studies, enabling quicker start times for lower-risk trials while maintaining safety standards.

The MHRA will also implement a 14-day assessment process for phase I trials, aimed at expediting early testing of new medicines.

Further updates include streamlined methods for assessing overseas safety data that meet UK requirements and enhanced capabilities to evaluate computer model simulations, such as in-silico trials. These changes reflect ongoing advances in medicine development while upholding robust safety measures.

Patient involvement in research has also grown, with more than 450,000 people participating in studies…

01/13/2026 | Agência SP

https://www.agenciasp.sp.gov.br/butantan-inicia-estudo-clinico-de-vacina-contra-gripe-em-pessoas-acima-de-60-anos/ 

New vaccine contains a substance in its formulation that enhances the immune response in the elderly and will be evaluated in more than 7,000 volunteers

The Butantan Institute began on Monday (January 12) the recruitment for the phase 3 clinical trial of the adjuvanted influenza vaccine, intended for the population aged 60 or older. The new vaccine has an adjuvant in its composition with the aim of increasing protection against influenza in the elderly, who naturally have reduced immunity and are more susceptible to complications from the disease.

The first stage of the clinical trial will evaluate the safety of the immunizing agent in 300 participants. Volunteers will be recruited from seven Brazilian research centers located in the states of São Paulo, Bahia, Sergipe, and Pernambuco.

Women and men aged 60 and over who are healthy or have treated and clinically stable comorbidities are eligible to participate. Individuals with immunodeficiency or unstable diseases will not be included.

The research centers involved in the first phase are: A2Z Clinical Advanced Clinical Research Center, in Valinhos (SP); Research Center of the Hospital das Clínicas de Ribeirão Preto, in Serrana (SP); Fundação Faculdade Regional de Medicina de São José do Rio Preto, in São José do Rio Preto (SP); Universidade Municipal de São Caetano do Sul, in São Caetano do Sul (SP); Associação Obras Sociais Irmã Dulce – Clinical Research Center, in Salvador (BA); Clinical Research Center of the Federal University of Sergipe, in Laranjeiras (SE); and Plátano…

01/12/2026 | Daniela Barros | Medscape

https://portugues.medscape.com/viewarticle/atrasa-diagn%C3%B3stico-cncer-colorretal-brasil-2026a10000wc?form=fpf 

In colorectal cancer, the moment of diagnosis is a silent milestone that separates patients who can still follow a predominantly curative trajectory from those who begin treatment in a scenario of greater clinical complexity, with high costs and a lower probability of prolonged disease control. This is the central message of the study "Colorectal Cancer in Brazil: The Invisible Challenge of Diagnosis," coordinated by the Cancer Foundation, which analyzed 177,575 cases of this type of tumor registered in Brazil between 2013 and 2022.

The majority of patients were ≥ 50 years old (85.9%) and almost half resided in the Southeast region (49.4%), reinforcing that the problem is not limited to areas with fewer resources, but also appears where there is a greater concentration of services and volume of care. More than 60% of cases with reported staging were diagnosed in stages III and IV, when the tumor has already spread beyond the intestine or has become widespread. "This is a catastrophe," states the oncological surgeon Dr. Luiz Augusto Maltoni, executive director of the Cancer Foundation.

“Diagnosis at an advanced stage completely changes the course of care: it increases the need to combine different treatment modalities—such as surgery, chemotherapy, and radiotherapy—raises the risk of complications, and imposes a high cost not only on the healthcare system but also on the patient and their family,” she says.

In stage IV, when the disease is already metastatic, the impact is even more evident, with a lower chance of cure and a worse overall prognosis. In early stages, the chance of cure can be greater than…

01/12/2026  |  Justin Gottlieb  |  Mayo Clinic

https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-qa-what-does-it-mean-to-be-in-a-cancer-clinical-trial/ 

DEAR MAYO CLINIC: Our daughter was recently diagnosed with cancer. She's interested in participating in a clinical trial but doesn't really know what that means or how to get involved. Can you help?

ANSWER: A cancer diagnosis can feel overwhelming and often comes with a long list of decisions to make. 

Many people are surprised to learn that clinical trials aren't just for people who have run out of standard treatment options, but are an important part of cancer care at every stage and most aspects of diagnosis and treatment. They help physicians study new and better ways to diagnose, treat and improve the quality of life for people. They also give patients access to promising treatments that they might not otherwise receive.

What happens in a cancer clinical trial?
During a clinical trial, participants may receive specific interventions or potentially the standard treatment. Researchers measure how safe and effective the interventions are and usually compare them to standard treatments. These may include:

• New cancer drugs or drug combinations.
• New medical procedures or devices.
• New surgical techniques.
• New ways to use existing treatments.
• Lifestyle or behavioral approaches.

One of the biggest misconceptions is that joining a trial means you might not receive treatment or be given a placebo. Most clinical trials compare a new treatment with the current standard of care.

Who's eligible for a trial?
Your daughter’s care team is the best starting point. Feel free to ask if she is a candidate…

01/12/2026  |  by/Staff Writer  |  Miller School of Medicine

https://news.med.miami.edu/why-so-many-head-and-neck-cancer-trials-fail/ 

Head and neck cancer ranks as the seventh most common cancer worldwide, and its incidence continues to rise. In the United States alone, 2025 projections estimate more than 72,000 new cases and 16,000 deaths. More than 90% of these cancers are head and neck squamous cell carcinomas, which originate in the mucosal lining of the oral cavity, pharynx and larynx.

While immunotherapy and precision chemoradiation have improved outcomes for some patients, survival rates for recurrent or metastatic head and neck squamous cell carcinomas remain dismal. Clinical trials are essential to finding better treatments, but many fail before completion.

A Troubling Trend for Head and Neck Cancer Clinical Trials
Researchers from Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and collaborators analyzed 692 clinical trials launched between 2000 and 2024.

Alex Reznik, an M.D./Ph.D. student at the Miller School and co-author of the study, described the study as “a retrospective query of head and neck cancer clinical trials in which we compared trial characteristics between failed clinical trials and completed clinical trials.”

The study included 346 studies that ended early, either terminated or were withdrawn. The leading culprits?

• Strategic decisions by sponsors, often unrelated to safety or efficacy (29.5%)

• Poor patient recruitment (26%)

Early-phase trials and those testing immunotherapies or targeted therapies were more likely to fail because of sponsor-driven decisions. Later-phase trials investigating chemotherapy, radiation or combination treatments struggled with enrollment.