09/29/2025 | Fernando de Rezende Francisco | Medicina S/A

https://medicinasa.com.br/sancao-lei-14-874-2024/ 

Brazil has begun a new chapter in Clinical Research with the enactment of Law No. 14,874/2024, which establishes a robust and modern regulatory framework in line with international best practices. More than just updating standards, the law creates conditions to expand the population's access to studies that bring innovation, new therapies, and a better quality of life.

Although the legislative process took almost a decade, the most recent stage of this process was marked by the leading role played by the Ministry of Health, through the Secretariat of Science, Technology, Innovation, and Health Complex (SECTICS) and the Department of Science and Technology (DECIT). In recent months, these areas have taken the lead on the agenda, competently and dialogically conducting the process that will culminate in the beginning of the regulation of the law and the reorganization of the ethical research system.

Despite its enormous potential, Brazil participates in just over 1% of global clinical studies, according to ClinicalTrials.gov. This means less investment, less access to cutting-edge technologies, and fewer opportunities for patients. Law No. 14,874/2024 paves the way for changing this scenario, and the recent actions of the Ministry of Health are decisive in consolidating these transformations.

The movement to draft a law for this area gained momentum in 2014 when Afonso Celso Haas, a businessman from Rio Grande do Sul diagnosed with advanced lung cancer, found a chance to prolong his life in a clinical trial. The experimental treatment not only gave him five additional years with his family, but also turned him into a symbol of the fight for the modernization of the sector.

Inspired by his story, doctors, lawmakers, organizations, and civil society…

10/01/2025 | Eurico Bitencourt Neto, Brunello Stancioli | Jota

https://www.jota.info/opiniao-e-analise/artigos/lei-14-874-24-uma-nova-perspectiva-para-a-pesquisa-clinica-no-brasil 

Legislation is welcome and represents a bioethical and administrative milestone for Brazilian research

Improvements in the health, well-being, and productivity of contemporary societies are largely linked to advances in biomedical research and the improvements they bring to collective and individual health. In an era marked by exponential production of information and knowledge and, at the same time, by growing uncertainty and risk, biomedical sciences play a central role as a tool that saves lives and prevents disease in a world that still grapples with profound inequalities, thus serving as an important instrument of social justice.

In this context of undeniable relevance, the progress of biomedical research involves a double ethical challenge. On the one hand, preventing or hindering scientific research means hindering prophylaxis, cure, and prevention for countless diseases, hindering the achievement of better health conditions and adequate care for those facing various causes of suffering. On the other hand, clinical research involves the participation of volunteers who agree to subject themselves to certain risks in order for scientific progress to be achieved, which requires a protection system that ensures the preservation of their fundamental rights of personality.

Ensuring the ethics of research and the safety and interests of research participants is fundamental in this process, as they are the key to the tests that culminate in scientific advancement. However, until last year, Brazil offered very fragile legal guarantees to research participants.

Research ethics standards in Brazil…

09/30/2025  |  Nick Charron and Hannah Yang  |  Clinical Leader

https://www.clinicalleader.com/doc/age-diversity-in-clinical-trials-considerations-for-improving-older-adult-representation-0001 

The share of the U.S. population aged 65 and older grew to 18% in 2024,1 now outnumbering children in nearly half of the country's counties. These demographic shifts are expected to continue, with estimates stating that the global population above 60 will double by 2050.2

It’s crucial to understand how these trends impact clinical trials,3 where older adults have historically been underrepresented. For several large oncology indications, the enrollment-to-incidence ratio (EIR) is only 25% for those above 70,4 revealing a significant discrepancy in inclusion.

Without prioritizing DEI, research findings aren’t fully generalizable5 to this key demographic, limiting the applicability of trials. In this piece, we dive into the importance of age diversity in clinical trials, breaking down innovative methods to redesign clinical trials and better engage older populations in the U.S.

Implications Of Underrepresenting Older Adults In Clinical Trials
Despite the shifting demographics of the U.S. population, only 50%6 of clinical trials specifically enroll patients under the age of 65, and 8% of trials enroll patients 80 and older. Many clinical trials also exclude older adults with comorbidities,7 further limiting their relevance to real-world populations.

While it’s true that comorbidities can complicate trial results and risk jeopardizing approval of a viable therapy, overly stringent inclusion/exclusion (I/E) criteria unnecessarily restrict participation. This exclusion creates a gap in data8 on efficacy and safety of treatments…

09/29/2025  |  Kerry Cullinan  |  Health Policy Watch

https://healthpolicy-watch.news/mobilisers-on-motorbikes-the-complex-process-of-involving-communities-in-clinical-trials/ 

Recruiting semi-nomadic people from West Pokot, Kenya, in a clinical trial meant those running the trial needed to know where to find them when they went in search of water and grazing for their animals.

Engaging people from a nomadic community in rural Kenya in a clinical trial involved employing community mobilisers on motorbikes and understanding seasonal and cultural practices.

Geographic touchpoints such as waterholes and schools were mapped as places to find trial participants as they searched for grazing and water for their cattle and goats.

This was a lot of work, but for Luke Kanyangareng, a nurse based in rural West Pokot, adjacent to the Ugandan border, the community is the main stakeholder in clinical trials.

“Clinical trials are about getting a solution to their health problems, so we need to recruit and keep rural patients in the trial,” said Kanyangareng, who recently won an international award for his role as a patient advocate.

“Understanding their life setup is also very important, because when you are doing recruitment, you should know where this patient is coming from, and where you expect to find this patient at different seasons of the year.” 

Kanyangareng was addressing a September 16 webinar on patient and community engagement in clinical trials.  The webinar, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)  was the first such event in a series of four, comprising this year’s African Regulatory Conference.  The online conference focused…

09/26/2025  |  Fred Lewsey  |  University of Cambridge

https://www.cam.ac.uk/research/news/common-diabetes-drug-and-antihistamine-could-together-repair-multiple-sclerosis-damage-trial-finds 

Scientists behind the trial say they are “on the brink of a new class of treatments” and that the findings take us another step closer to stopping disease progression in MS.

A combination of metformin, a common diabetes drug, and clemastine, an antihistamine, can help repair myelin – the protective coating around nerves, which gets damaged in multiple sclerosis (MS) causing symptoms like fatigue, pain, spasms and problems with walking.

"My instinct is that we are on the brink of a new class of treatments to stop MS progression"
Dr Nick Cunniffe

This is according to early findings from the phase two clinical trial, CCMR-Two, carried out by researchers at the University of Cambridge’s Department of Clinical Neurosciences, and funded by the MS Society.

The scientists say the results take us another step closer to finally being able to stop disease progression in MS. However, they stress that people should not attempt to acquire the drugs outside a clinical trial, as further research is needed to fully understand their efficacy and safety in MS.

Previous evidence from animal studies showed that metformin enhances the effect of clemastine on myelin repair, but until now the two drugs had never been tested together in people. News of the latest trial was presented today at this year’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – one of the world’s biggest MS research conferences.

“I am increasingly sure that remyelination is part of the solution…