The Pediatric CNS Immunotherapy Signal That Sponsors Are Underreading
ReMIND's multi-antigen T cell data in 25 pediatric CNS patients points to a regulatory inflection point sponsors haven't mapped...
Adaptive Clinical Trial Design
Definium’s Phase 3 LSD Win Is Real. The Fracture It Exposed Is Bigger.
Definium's LSD trial hit p<0.0001 and a $700M raise. But credible voices are asking whether FDA's drug model can...
VR Plus Neurostimulation Just Cleared a Major Feasibility Hurdle. Now Comes the Hard Part.
A Nature Medicine feasibility trial combining immersive VR with synchronous neurostimulation hit enrollment and kinematic endpoints in stroke rehab....
What a 26-Trial Ketamine Meta-Analysis Gets Right, and What It Still Can’t Capture
A JAMA Psychiatry meta-analysis of 26 RCTs confirms ketamine's acute antidepressant effect. Here's what 1,166 trial patients don't show...
AI Aced the Boards. It Failed the Clinic. The Kenya Trial Reveals a Gap the Industry Can’t Ignore.
A cluster-RCT across 16 Kenya primary care clinics found ChatGPT-4o-assisted decision support improved documentation but missed on patient outcomes...
An Open Letter to Acting Commissioner Diamantas: The FDA Needs a Regulatory Pathway for Vaccine-Based Dementia Prevention Trials Now
Nature Medicine just made the case for large-scale RCTs of live-attenuated shingles vaccination for dementia prevention. Acting Commissioner Diamantas,...
Adaptive DBS Just Rewrote the Rules for CNS Trial Design — Is the FDA Ready?
A Nature Medicine randomized trial shows adaptive DBS cuts gait variability in Parkinson's. The real story is what its...
Closed-Loop DBS Just Validated a New Class of CNS Trial Design. Is Your Protocol Ready?
A UCSF randomized trial of adaptive DBS in Parkinson's gait published in Nature Medicine signals a coming wave of...