MASH Trials Are Screening Out the Patients They Were Designed to Treat
MASH trial NIT thresholds misalign with clinical practice, creating screen failure crises that delay approvals and exclude the patients...
PROSpect Proved Two Treatments Don’t Work. The Real Story Is What That Took.
PROSpect's phase 3 RCT enrolled 424 children with PARDS and found neither prone positioning nor HFOV improves ventilator-free days....
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...
MDT-BRIDGE Phase 2 Data Signals a Protocol-Driven Model for Adaptive Resectability Assessment in Neoadjuvant NSCLC
The MDT-BRIDGE trial's 142-patient neoadjuvant durvalumab dataset introduces a multidisciplinary reassessment architecture that FDA's existing perioperative…
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...
Pelacarsen Lowered the Biomarker. It Did Not Save Lives. Now What?
Novartis's pelacarsen hit its Lp(a) target in 8,323 patients but missed the cardiovascular endpoint entirely, exposing a $6B assumption...
Base Editing’s Decade of Promise Meets Its Regulatory Reckoning
Base editing reached human trials, but the FDA's April 2026 NGS safety draft guidance reveals how far the regulatory...
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...
Phage Therapy Trials Are Launching Without a Regulatory Playbook. That’s a Problem.
Phage therapy trials for drug-resistant UTIs are advancing with no FDA guidance document, here's why comparator selection and resistance...
Replication Is Dead. Corroboration Is the Standard Clinical Trials Must Meet Now.
The NEJM just reframed reproducibility in biomedical science, and every clinical trial sponsor still designing for repetition is building...