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...
Real-World Evidence
LITMUS Changes the Biopsy Calculus: What the Nature Medicine Data Means for Your MASLD Protocol
A Nature Medicine study using the 10,000-patient LITMUS registry shows non-invasive fibrosis tests can replace liver biopsy endpoints. Here's...
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...
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...
The LITMUS Study Just Changed How You Should Design Your MASLD Trial Endpoints
LITMUS Imaging Study validates imaging and serum biomarkers for MASLD fibrosis—here's what it means for endpoint strategy in your...
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...
Digital Twins Are Rewriting Clinical Trial Math. The Validation Problem Could Erase the Gains.
Biotech's digital twin rush is outpacing regulatory frameworks. Without standardized qualification, sponsors risk building trial strategies on unvalidated…
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...
The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
A NEJM pragmatic trial of a 6-month rifampicin-resistant TB regimen just set a new benchmark for adaptive evidence generation...
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...