PROSpect’s Negative Findings Should Change How We Design Pediatric Critical Care Trials Forever
PROSpect enrolled 424 children across 75 PICUs in 18 countries to test prone positioning and HFOV in PARDS, and...
Adaptive Clinical Trial Design
PROSpect’s Negative Findings Are the Most Important Data in Pediatric Critical Care This Decade
The PROSpect trial found neither prone positioning nor HFOV improved ventilator-free days in PARDS, and the trial design that...
When the “Standard of Care” Fails the Trial: What PROSpect’s Negative Findings Reveal About Pediatric Critical Care’s Evidence Crisis
PROSpect's factorial RCT found no benefit from prone positioning or HFOV in moderate-to-severe PARDS, forcing a reckoning with two...
Can Psychedelics Restore Consciousness? The Trial Design Problem Nobody Is Ready For
A Molecular Psychiatry review asks whether psilocybin can reach minimally conscious patients, and exposes the outcome measurement gaps trials...
The Enzyme Nobody Watched: How Mitapivat’s Phase 3 Win Rewrites the Rules for Sickle Cell Drug Development
Mitapivat hit a 40.6% hemoglobin response rate in the RISE UP Phase 3 trial, and the endpoint strategy that...
GLP-1 Drugs Linked to Fewer Psychiatric Hospitalizations in People With Schizophrenia and Type 2 Diabetes
A Lancet Psychiatry cohort of 70,257 schizophrenia patients shows GLP-1 agonists reduce acute psychiatric care. Trial design hasn't caught...
The Psilocybin Layer 5 Finding Changes How I Think About What We’re Actually Dosing For
A Nature Neuroscience study separates psilocybin's neuroplastic effects from its hallucinogenic ones, and it should reshape how we design...
Icotrokinra’s NEJM Data Reveals the Quiet Shift in How UC Trials Get Designed and Approved
J&J's icotrokinra hit every UC endpoint in NEJM's Oct 2026 data, and the trial design choices behind that success...
The CHMP’s October Scorecard: Six Approvals, Five Expansions, and What the Patterns Reveal About EMA’s Evolving Evidence Bar
EMA's CHMP recommended 6 new medicines and 5 label expansions in its Oct 12-15 cycle. Here's what daraxonrasib's pancreatic...
The Comparator Arm Is the Trial: Why OptiTROP-Lung05’s Design Debate Exposes a Structural Problem in Oncology Phase 3s
OptiTROP-Lung05's HR of 0.35 over pembrolizumab monotherapy looks decisive, until you ask whether that comparator still reflects standard of...