10/03/2025  |  Denise N. Bronner  |  Clinical Leader

https://www.clinicalleader.com/doc/how-government-shutdowns-set-back-clinical-trials-0001

When the federal government shuts down, news coverage tends to spotlight furloughed workers, frozen paychecks, or the political drama playing out in Washington. What gets less attention is how these lapses stall the engine of scientific progress. For clinical research, even a brief shutdown can trigger cascading consequences: disrupted operations, wavering patient participation, delayed approvals, and setbacks for urgently needed therapeutics.

Clinical research thrives on continuity. It is built on tightly orchestrated timelines, fragile patient trust, and a steady flow of regulatory and financial resources. When that continuity is interrupted, the ripple effects extend far beyond missed deadlines. They reach the lives of patients who depend on trials for care and the future of therapies waiting to move from pipeline to practice.

Regulatory Bottlenecks & Uncertainty
The FDA sits at the center of clinical research, reviewing new drug applications, monitoring safety, and ensuring compliance. A shutdown leaves the agency with only a skeleton crew. Historically, about one-third of FDA staff have been furloughed during extended shutdowns, forcing the Agency to pause most routine operations. New drug and device submissions may be accepted, but reviews stall. Site inspections and audits, critical for moving programs forward, are postponed. And sponsors often find their regulatory queries met with silence.

These delays may seem procedural, but they create real-world consequences. A biotech preparing to launch a pivotal trial might suddenly find its timeline upended. A CRO monitoring multiple sites may have to cancel visits, raising questions…

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…