Platform Trials Are Rewriting the Rules of Evidence. Regulators Haven’t Caught Up.
Adaptive platform trials like REMAP-CAP enrolled 4,869 critically ill COVID patients across 300+ sites, but FDA's master protocol guidance...
Adaptive Clinical Trial Design
The EPoS II Trial Just Made the 3-Year Colonoscopy Standard Look Like a Reflex, Not a Rule
EPoS II RCT finds 5-year colonoscopy surveillance noninferior to 3-year for high-risk adenoma patients, forcing a rethink of global...
FDA’s 2026 Single-Trial Default Standard Reframes the Dual-Pivotal Debate for Sponsors Still Designing Phase 3
FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3...
The Liquid Biopsy That Found Pancreatic Cancer Early Has a Bigger Regulatory Problem Than Its Science
PANXEON detects stage 1-2 pancreatic cancer with 87% sensitivity, but FDA's companion diagnostic pathway may be the bigger obstacle...
What the Lancet Psychiatry Mania Data Gets Right, and What It Still Can’t Tell Us
A new target trial emulation in Lancet Psychiatry challenges antipsychotic-first strategies in early psychotic mania. Here's what it means...
Benchmark Scores Don’t Save Patients: Why Clinical AI Needs RCT-Grade Evidence Before It Touches a Workflow
Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...
The FDA Just Handed Psychedelic Drug Sponsors a Framework. Now the Hard Part Starts.
FDA finalized its psychedelic drug guidance July 14, 2026. COMPASS, Usona, and MAPS now face blinding failures, DEA barriers,...
What FDA’s July 2026 Psychedelic Drug Guidance Actually Says About Trial Design
FDA's finalized psychedelic guidance rewrites the rules on blinding, informed consent, and session monitoring, and the NEJM's September 2026...
What the FDA’s New Psychedelic Framework Actually Means for the Clinic
FDA's September 2026 NEJM framework for psychedelic drugs reshapes trial design, REMS requirements, and patient access for psilocybin and...
Proteomic Aging Clocks Just Changed What a Phase 2a Trial Has to Prove
A Nature Biotechnology phase 2a trial ran six proteomic aging clocks simultaneously, here's what that means for biomarker strategy...