Daraxonrasib’s Resistance Map Is a Blueprint for How Oncology Trials Should Be Designed
Daraxonrasib's Phase 3 data in pancreatic cancer reveals how ctDNA-guided resistance profiling can reshape adaptive trial design—before acquired resistance…
AI Drug Discovery Has $8.9 Billion in Hype and Zero FDA Approvals: When Does the Bill Come Due?
AI drug discovery raised $8.9B in 2024, yet no AI-discovered drug holds FDA approval. The gap between algorithmic promise...
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...
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...
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...
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...
The Hybrid Vaccine Trial Design That Could Render Pure RCTs Obsolete
A landmark NEJM editorial argues combining RCT and observational data can unlock vaccine effectiveness insights no single design can...
The 2-Week Window: What a Phase 1 iPSC Trial Teaches Us About Designing Cell Therapy Studies That Can Actually Win Approval
A Nature Medicine phase 1 iPSC neural progenitor trial in subacute spinal cord injury shows how to build the...
The Blood-Brain Barrier Has Been Breached. Is Clinical Trial Science Ready?
FDA's March 2026 approval of AVLAYAH marks the first BBB-crossing biologic — but CNS trial design, PK monitoring, and...