Redefining Phase 1 for Cancer Trial: The FDA’s Latest Guidance  

Early-phase oncology trials operated under a simple, brutal logic: push the dose until the patient breaks, then step back one notch. While that “maximum tolerated dose” mindset made sense for traditional cytotoxic chemotherapy, modern targeted therapies, biologics, and cell therapies play by entirely different biological rules. At the same time, overly rigid eligibility checklists routinely … Read more

How Artificial Intelligence is Quietly Reshaping Clinical Trials 

The integration of artificial intelligence (AI) within clinical research is expanding across multiple medical specialties. While discussions surrounding technological applications in healthcare are frequent, empirical data on how these tools are deployed remains critical. A recent cross-sectional study published in JAMA examines interventional trials to characterize planned artificial intelligence implementations. The study provides a view … Read more