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...
Clinical Trial Design
Spatial CRISPR Screening Just Made Your Preclinical Models Look Like Guesswork
Nature Biotechnology's Perturb-DBiT maps CRISPR perturbations in native tissue — and exposes why dissociated-cell screens keep producing trials that...
Psychedelic Trials Are Producing Stunning Numbers. The Methodology Underneath Them May Not Hold.
Luvesilocin's 70% PPD remission rate and psilocybin-CBT pilot data are turning heads—but sex-specific blind spots and a therapy model...
The EMPHASIS Trial Correspondence Surfaces Three Trial Design Constraints That Will Shape the Next Neuroprotection Protocol
A Lancet correspondence on EMPHASIS identifies patient selection limits, generalisability gaps, and statistical design issues that every stroke trial...
China’s Tenecteplase Trial Just Challenged the Global Stroke Playbook — and the FDA Should Be Paying Attention
A phase 3 RCT from China finds tenecteplase before EVT cuts disability in proximal MCA occlusion strokes 4.5–24 hrs...
The Neurological Drug Development Machine Is Broken. Platform Trials Are the Wrench.
MAMS platform trials could cut neurodegenerative drug timelines—but adaptive stopping rules and FDA guidance gaps threaten to stall the...
Psychedelic Trials Are Effectively Open-Label. The FDA Has to Decide What to Do With That.
A meta-analysis of 112 psychedelic RCTs found >90% unblinding rates, meaning every efficacy estimate in the field may be...
Decentralized Trials Are Everywhere. Nobody Agrees What They’re For.
DCTs promise faster enrollment and broader diversity, but sponsors, CROs, sites, and regulators each want something different—and the TELEPIK...
The Platform Trial Takeover: Neurology’s Last Best Chance to Stop Failing Patients
Multi-arm multi-stage platform trials could cut neurodegenerative drug timelines in half—but FDA adaptive design rules haven't caught up with...
ADHD Dosing Has Two Failure Modes, and Trials Are Designed to Miss Both
A Lancet Psychiatry network meta-analysis of ADHD pharmacotherapy exposes therapeutic inertia and uncritical dose escalation as twin hazards—with direct…