EU Clinical Trials Face Cost, Speed, and China Competition Pressure
At the Clinical Trial Innovation Summit 2025 in Basel, industry leaders from UCB, Novo Nordisk, Novartis, and Medable debated...
Moe Alsumidaie
How LLMs Can Audit LSD Clinical Trial Ratings in Real Time
MindMed is running three phase three trials of pharmaceutically optimized LSD with a two-person AI team and a custom...
AI Platform Predicts Clinical Trial Outcomes with High Accuracy
At the Clinical Trial Innovation Summit 2025 in Basel, QuantHealth's Chief Medical Officer presented AI-driven trial simulation technology capable...
Novartis Restructures Clinical Ops to Scale Trial Innovation Beyond Pilots
Novartis built a dedicated Global Clinical Operations Innovation Team 18 months ago to move past one-off pilots and embed...
The ICU Trial That Should Embarrass Every Sponsor Hiding Behind “Ethical Complexity”
A JAMA RCT on ICU restraint strategies just proved rigorous trial design works even in critically ill patients —...
Ewing Sarcoma’s EWS::FLI1 Trial Just Showed What Precision Oncology Has Been Promising for a Decade
A Nature Medicine phase 1/2 trial of trabectedin plus low-dose irinotecan targeting EWS::FLI1 in Ewing sarcoma signals a new...
The Imaging Gap in GLP-1 Trials: Why the Most Important Data May Not Be in Your Protocol
Professor Mikael Boesen Professor of Musculoskeletal Radiology & Head of Imaging Research, Copenhagen University Hospital Bispebjerg and Frederiksberg A...
The MASAI Trial Just Made AI-Augmented Mammography the Standard of Care. The FDA Hasn’t Noticed
The MASAI trial showed AI-plus-one-radiologist outperforms two radiologists in breast cancer screening. FDA's AI device framework still treats this...
The Liver Signal Europe Just Sent About Cenobamate Will Reshape How Sponsors Design Post-Approval Safety Plans
The EMA's PRAC issued a direct communication to healthcare professionals about severe liver injury linked to cenobamate in April...
France Approved IV Ketamine for Suicidal Crisis. The FDA Should Be Uncomfortable Right Now.
France's March 2026 authorization of intravenous racemic ketamine for acute suicidal crisis is the first regulatory approval of its...