AI Clinical Decision Support Is Everywhere. The Evidence Base Is Not.
71% of US hospitals now deploy predictive AI, but validation frameworks lag dangerously behind. Here's what that gap means...
RiboX’s Circular RNA CAR-T IND Clearance Forces the Industry to Rethink Everything It Knows About Cell Therapy Trial Design
FDA cleared RiboX's RXIM002 IND for the first circular RNA-based in vivo CAR-T therapy — here's what it means...
The FDA Measures All Schizophrenia Symptoms at the Same Clock. A Six-Trial IPD Analysis Just Proved That’s Wrong.
A Lancet Psychiatry IPD meta-analysis of six antipsychotic trials shows hostility resolves weeks before negative symptoms—exposing a critical flaw...
A Maternal GBS Vaccine Just Cleared Phase 1/2. Here’s What the Trial Design Tells Us About the Regulatory Gauntlet Ahead.
Pfizer's 6-valent GBS vaccine cleared Phase 1/2 with strong immunogenicity data in pregnant women. Here's what the trial design...
The Inherited Retinal Disease Trial That Should Change How Sponsors Think About AI Diagnostic Evidence
A multicenter RCT in Nature Medicine just validated AI-based IRD diagnosis—and exposed a gaping hole in how the FDA...
Roche’s Englumafusp Plus Glofitamab Combination Shows Why Phase 1 Trial Design Is the Real Competitive Moat in Bispecific Oncology
A Nature Medicine Phase 1 trial combining englumafusp alfa and glofitamab in B-cell NHL reveals how rational dose escalation...
The Trial You Never Have to Run: How Simulation Is Rewriting Clinical Development Economics
Nature Reviews Drug Discovery's 2026 simulation-guided trial framework shows sponsors how digital modeling can cut sample sizes 13–23% and...
The Trial Without Walls: How Real-World Evidence Is Rewriting the Rules of Drug Approval
Nature Medicine's RWE trial emulation framework is reshaping FDA approval pathways. Here's what sponsors running traditional RCTs need to...
Harvard’s COMPASS Model Just Made Immunotherapy Trial Design More Complicated
Harvard's COMPASS AI predicts checkpoint inhibitor response across 33 cancer types with 8.5% better accuracy—but translating that into trial...
VR Plus Neurostimulation Just Cleared a Major Feasibility Hurdle. Now Comes the Hard Part.
A Nature Medicine feasibility trial combining immersive VR with synchronous neurostimulation hit enrollment and kinematic endpoints in stroke rehab....