The Patients We’ve Been Afraid to Treat: PTSD, Psychosis, and What the STAR Trial Just Proved
The STAR trial enrolled 305 psychosis-PTSD patients clinicians long excluded from trauma therapy. The safety and efficacy data should...
The Consent Form Doesn’t Cover the Data: A Gap Regulators Can No Longer Ignore
Nature Medicine flags data rights as consent's missing pillar—and three converging signals show the FDA's frameworks haven't caught up...
The Geroscience Biomarker Gap: Why Immune Aging Endpoints Are About to Reshape Trial Design
Nature Medicine's immune aging biomarker framework challenges sponsors to redesign geroscience trials around surrogate endpoints the FDA hasn't yet...
Harvard’s COMPASS Model Just Made Immunotherapy Trial Design More Complicated
Harvard's COMPASS AI predicts checkpoint inhibitor response across 33 cancer types with 8.5% better accuracy—but translating that into trial...
What a Single-Dose Synthetic Psychedelic Teaches Us About the Limits of Our TRD Trial Designs
A JAMA Psychiatry trial of inhaled mebufotenin in TRD shows rapid antidepressant response, and exposes critical gaps in how...
What Semaglutide’s Fentanyl Data Should Mean for How We Design the Next OUD Trial
New preclinical data shows semaglutide cuts fentanyl self-administration in rats, and raises hard questions about OUD trial design for...
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...
The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
A NEJM pragmatic trial of a 6-month rifampicin-resistant TB regimen just set a new benchmark for adaptive evidence generation...
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...