TALENTOP Proved Conversion Surgery Works in Advanced HCC. Now Comes the Harder Question.
TALENTOP's phase 3 data shows liver resection after atezo-bev nearly doubles time to treatment failure in advanced HCC. The...
Adaptive Clinical Trial Design
The Oregon Dataset Is Larger Than the Entire History of Psychedelic Trials. So Why Are Regulators Still Looking the Other Way?
OHSU's 2,363-person Oregon psilocybin dataset dwarfs every RCT in the field's history. Here's what it tells us that clinical...
Dronabinol for PTSD Nightmares Is Promising, and the Dual Diagnosis Question Changes Everything
A Nature Medicine RCT shows dronabinol cuts PTSD nightmares. For the 46% of PTSD patients who also carry a...
Psilocybin Works in the Lab. Can It Survive the Clinic?
A UK NHS psilocybin trial exposes the standardization gap threatening psychedelic drug approval — therapist training, setting protocols, and...
iPSC Cardiomyocytes Reach the Beating Heart: What This Trial Design Tells Sponsors About the Next Frontier of Cell Therapy Protocols
A Nature Medicine RCT of allogeneic iPSC-derived cardiomyocytes in advanced ischemic heart failure just set the protocol bar for...
FDA Has Authorized 1,500 AI Medical Devices. The Evidence for Most of Them Is Still Catching Up.
Over 1,500 AI-enabled medical devices have FDA authorization, yet rigorous RCT validation trails far behind. Here's the mechanism breaking...
LSD Just Beat Phase 3 Twice. Now Comes the Hard Part.
Definium's DT120 cleared Phase 3 in both MDD and GAD. As a ketamine PI who's treated 30,000+ patients, here's...
AI Clinical Decision Support Is Everywhere. The Evidence Base Is Not.
71% of US hospitals now deploy predictive AI, but validation frameworks lag dangerously behind. Here's what that gap means...
AI Is Clearing Phase I. That’s the Wrong Finish Line.
Of 117 AI-enabled drug assets tracked in clinical trials, only 8 have cleared Phase II. Speed is real. Efficacy...
RiboX’s Circular RNA CAR-T IND Clearance Forces the Industry to Rethink Everything It Knows About Cell Therapy Trial Design
FDA cleared RiboX's RXIM002 IND for the first circular RNA-based in vivo CAR-T therapy — here's what it means...