The Brain Is the Frontier: Inside the Trial That’s Rewriting the CAR-T Playbook for Glioblastoma
A Phase 1 trial delivers B7-H3-targeting CAR-T cells directly into the brain of recurrent GBM patients — and the...
Adaptive Clinical Trial Design
The Recruiter in the Frame: What a Danish RSV Trial Reveals About Who Gets to Invite You Into a Study
A nested trial inside DAN-RSV found that video presenter sex affects adult enrollment decisions, exposing a mechanism most protocol...
The Clinical Trial That Asks Whether Your Current Treatment Should Exist
JAMA's deescalation trial framework forces a reckoning: 22% of prescriptions are unnecessary, and regulators have no standard playbook for...
Routine Health Data Is Outperforming Trial Data for AI Training. The FDA Hasn’t Caught Up.
Nature Medicine finds neuroimaging AI trained on routine health system data beats curated trial datasets. FDA's RWE framework for...
Latigo’s LTG-001 Phase 2b Data Signals a New Design Standard for NaV1.8 Pain Trials
Latigo Biotherapeutics' LTG-001 hit SPID48 in 343 patients, published in NEJM — here's what the trial design tells regulators...
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...
GLP-1s Are Cutting My AUD Patients’ Hospitalizations. Trial Designers Need to Know Why.
A Lancet Psychiatry study links GLP-1 receptor agonists to fewer AUD and SUD hospitalizations—but the post-discontinuation signal demands a...
Long COVID’s Phase 3 Reckoning: What STIMULATE-ICP Reveals About Designing Trials for Diseases Medicine Can’t Yet Explain
STIMULATE-ICP's cluster-randomized Phase 3 design for Long COVID exposes a fundamental tension in trial methodology: how do you randomize...
Capricor’s Deramiocel Briefing Is a Masterclass in How Not to Define an Endpoint
FDA's July 27 briefing document for Deramiocel (BLA 125842) contradicts Capricor's Phase 3 efficacy claims ahead of tomorrow's AdCom...
Nature Medicine’s 2026 Medical AI Superintelligence Framework Signals What FDA Benchmarking Guidance Has Not Yet Addressed
Nature Medicine's July 2026 AI superintelligence framework exposes a critical gap: FDA has no task-based benchmarking standard for medical...