The Bispecific Combination Wave Is Here: What the Englumafusp-Glofitamab Trial Signals for Hematology Trial Design
A Phase 1 trial pairing englumafusp alfa with glofitamab in B-cell NHL reveals a mechanistic shift reshaping how sponsors...
Checkpoint Inhibitors Are Failing Recurrent GBM. This Phase 1 Trial Design May Explain Why They Keep Trying.
A 46-patient LAG-3/PD-1 phase 1 trial in recurrent GBM reveals the protocol innovations sponsors need before scaling immunotherapy in...
The Consent Form Doesn’t Cover the Data: A Gap Regulators Can No Longer Ignore
Nature Medicine flags data rights as consent's missing pillar—and three converging signals show the FDA's frameworks haven't caught up...
The Pediatric CNS Immunotherapy Signal That Sponsors Are Underreading
ReMIND's multi-antigen T cell data in 25 pediatric CNS patients points to a regulatory inflection point sponsors haven't mapped...
AI Aced the Boards. It Failed the Clinic. The Kenya Trial Reveals a Gap the Industry Can’t Ignore.
A cluster-RCT across 16 Kenya primary care clinics found ChatGPT-4o-assisted decision support improved documentation but missed on patient outcomes...
The Specialized Clinical AI Trap: General-Purpose Chatbots Are Winning the Benchmark War
A Nature Medicine study shows general-purpose LLMs outperform specialized clinical AI tools on real physician questions—exposing a validation crisis...
Closed-Loop DBS Just Validated a New Class of CNS Trial Design. Is Your Protocol Ready?
A UCSF randomized trial of adaptive DBS in Parkinson's gait published in Nature Medicine signals a coming wave of...
CNS Gene Therapy Trials Are About to Break Every Monitoring Assumption Your CRO Has
BBM-P002's multicenter Phase 1 Parkinson's data signals a wave of CNS gene therapy trials that will overwhelm standard eClinical...
The Platform Trial Takeover: Neurology’s Last Best Chance to Stop Failing Patients
Multi-arm multi-stage platform trials could cut neurodegenerative drug timelines in half—but FDA adaptive design rules haven't caught up with...
The Oversight Gap Nobody Is Naming: State Sandboxes Are Filling a Void the FDA Has Left Open
Utah's clinical AI sandbox and the FDA's 1,451 AI device authorizations reveal a structural oversight gap—states are building what...