AI Is Now Running Clinical Trials. The Question Is Whether Anyone Is Watching.
From a cancer patient's self-built AI agent to ARPA-H's phaseless trial model, AI has crossed from analytics into operations....
The FDA Created an AI Office. Now Comes the Hard Part.
CDER's new Office of Innovation and Clinical Trial Modernization fuses AI and RWE policy under one roof. That structural...
The 90% Automation Promise Means Nothing to a Coordinator Running 12 Systems
Medable's CEO wants 90% of clinical trials automated by 2030. Site coordinators are still manually bridging 12 disconnected systems....
Compass Pathways Just Answered the Durability Question. Now Comes the Harder Problem.
Compass Pathways' 52-week COMP360 data shows 40-45% response rates in treatment-resistant depression. FDA approval in 2027 means nothing without...
AI in Clinical Trials Doesn’t Have a Capability Problem. It Has a Honesty Problem.
Six AI models picked the same "random" number. Clinical ops leaders are finally asking what that reveals about every...
Benchmarks Don’t Fail Silently. Agentic AI Does.
Scale AI's CliniCARE-Bench found 34.7% error rates and right-answer-wrong-process failures. The clinical trials field has no governance framework to...
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...
NIH Just Killed the Training Ground for Clinical Trialists. The Damage Will Take a Decade to See.
NIH's Program Update 3 eliminates Independent Clinical Trial Required K awards — 573 active K23s affected. The clinician-scientist pipeline...
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...
Psilocybin Has Crossed the Evidence Threshold. Clinical Guidelines Have Not.
Compass Pathways' Phase 3 six-month data and a first-ever psilocybin-PTSD veteran trial signal readiness — but the guideline infrastructure...