FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...
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 —...
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...
MRD Is Now the Endpoint That Matters: The EMN24 IsKia Trial Just Proved It
The EMN24 IsKia phase 3 trial didn't just test a new drug combination for newly diagnosed multiple myeloma —...
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...
The POLAR Trial Proves Pancreatic Cancer Trials Were Broken by Design
The POLAR trial's Phase 2 results in homologous-recombination-deficient metastatic pancreatic cancer aren't just a clinical win — they're an...
The FDA Doesn’t Have a GLP-1 Problem. It Has an Evidence Problem.
A trial emulation study of 174,678 type 1 diabetes patients shows GLP-1RAs cut major cardiovascular events and end-stage kidney...
Greenwich LifeSciences Switched Drug Product Mid-Pivotal Trial. The FDA Has Rules About That.
Greenwich LifeSciences announced mid-trial use of commercially manufactured GP2 in its Phase III FLAMINGO-01 study. What looks like a...