NSABP B-59 Failed. The Real Question Is Why We Keep Designing Trials That Can’t Detect the Signal.
The NSABP B-59/GeparDouze trial enrolled 1,550 TNBC patients and missed its primary endpoint. Atezolizumab's Phase 3 failure reveals a...
When a Failed Primary Endpoint Teaches More Than a Win: What CARDIOTTRansform’s Secondary Analysis Reveals About Stratification in Complex Trials
CARDIOTTRansform missed its primary endpoint, but its secondary analysis of eplontersen in ATTR-CM patients on background stabilizers is reshaping...
Lecanemab’s At-Home Start Dose Just Rewrote the Rules for Alzheimer’s Trial Design
FDA's July 2026 approval of at-home subcutaneous lecanemab initiation eliminates the 18-month IV requirement, reshaping CNS trial recruitment and...
Dubai’s rWGS Scale-Up Rewrites the Diagnostic Playbook — But the Data Infrastructure Problem Stays Unsolved
Dubai Health's rapid whole-genome sequencing rollout for critically ill children delivers diagnostic yields that dwarf standard testing, but exposes...
Psychiatry’s Stratification Crisis: How Biomarkers Are Finally Breaking the DSM’s Grip on Trial Design
Precision psychiatry biomarkers are reshaping CNS trial stratification — here's what the shift from symptom-based DSM criteria to biotype-driven...
Rapid Whole-Genome Sequencing Is Leaving the Research Ward and Entering the PICU Protocol — What Sponsors Need to Watch
Nature Medicine's citywide Dubai rWGS study and Seattle Children's 1,000-patient rollout signal a regulatory inflection point for genomic diagnostics...
Dronabinol for PTSD Nightmares Is Promising, and the Dual Diagnosis Question Changes Everything
A Nature Medicine RCT shows dronabinol cuts PTSD nightmares. For the 46% of PTSD patients who also carry a...
Psilocybin Works in the Lab. Can It Survive the Clinic?
A UK NHS psilocybin trial exposes the standardization gap threatening psychedelic drug approval — therapist training, setting protocols, and...
AI Antibody Design Just Got Its First Honest Report Card — And the Grade Is Complicated
A blinded 29-org benchmark in Nature Biotechnology tested 511 AI-designed antibodies against experimental data. No single algorithm won. Here's...
iPSC Cardiomyocytes Reach the Beating Heart: What This Trial Design Tells Sponsors About the Next Frontier of Cell Therapy Protocols
A Nature Medicine RCT of allogeneic iPSC-derived cardiomyocytes in advanced ischemic heart failure just set the protocol bar for...