Pediatric Oncology Keeps Getting Treated as an Afterthought. The Biology Disagrees.
Children with cancer wait 6.5 years longer than adults to access new drugs. Adaptive and tumor-agnostic designs can close...
Adaptive Trial Design
Neurodegenerative Drug Development Has a 2% Success Rate. Platform Trials Are the Only Honest Response.
With 51% of Alzheimer's disease-modifying compounds failing Phase III, The Lancet's case for MAMS platform trials in neurology isn't...
The Alzheimer’s Agitation Approval That Should Rewrite How We Think About Antipsychotics in Geriatric Psychiatry
Auvelity's FDA expansion into Alzheimer's agitation—peak sales now projected at $8B—exposes how long antipsychotics dominated a space where safer...
DIPG’s Biomarker Reckoning: What BIOMEDE Tells Us About Precision Oncology Trial Design When the Primary Endpoint Fails
BIOMEDE screened 279 DIPG patients across 45 centers using biopsy-driven tumor profiling — and its biomarker signals outlasted its...
Enpatoran’s Phase 2 Miss Exposes a Protocol Design Flaw That Every SLE Sponsor Needs to Confront
Enpatoran improved BICLA response rates in moderate-to-severe SLE but failed its primary dose-dependent endpoint—a design flaw sponsors can't afford...
The Survival Signal That Should Redesign Every RAS-Mutant Pancreatic Trial Running Right Now
Daraxonrasib cut pancreatic cancer mortality nearly in half vs. chemo in the RASolute 302 Phase 3 trial — here's...
When J&J Eliminates the Interim: What the NANORAY-312 Amendment Actually Signals
J&J's FDA-accepted protocol amendment to NANORAY-312 drops the interim analysis for NBTXR3—here's what that move reveals about pivotal trial...
FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
AI Platform Predicts Clinical Trial Outcomes with High Accuracy
At the Clinical Trial Innovation Summit 2025 in Basel, QuantHealth's Chief Medical Officer presented AI-driven trial simulation technology capable...