Benchmark Scores Don’t Save Patients: Why Clinical AI Needs RCT-Grade Evidence Before It Touches a Workflow
Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...
What FDA’s July 2026 Psychedelic Drug Guidance Actually Says About Trial Design
FDA's finalized psychedelic guidance rewrites the rules on blinding, informed consent, and session monitoring, and the NEJM's September 2026...
DYNAMIKA™: The Operating System for Imaging Clinical Trials
Sponsored by Image Analysis Group. Why the imaging platform decision is the single most consequential infrastructure choice a sponsor...
The 400-Member Protein Family That Neuroscience Has Almost Entirely Ignored
Nature Reviews Drug Discovery identifies SLC transporters as untapped CNS drug targets, but 97% remain undrugged, and trial designers...
In Vivo CAR-T for CNS Autoimmune Disease Looks Promising. The Trial Design Problem Is Hiding in Plain Sight.
NEJM's lentiviral in vivo CAR-T data in neurologic autoimmune disease is compelling, but the trial infrastructure to validate it...
The EMA Just Opened a Door That Animal Testing Has Kept Closed for Decades
EMA's September 2026 NAM data pilot lets sponsors share organ-chip and computational data directly with regulators, reshaping preclinical drug...
Nature Medicine’s 38,753-Patient HF Synthesis Signals a Replicable Model for RWE-Driven Label Expansion Without New RCTs
A 38,753-patient cross-trial synthesis in Nature Medicine maps short-term safety of HF combination therapies—signaling how sponsors can use pooled...
Reading the COMPARE Phase 1 Data in Nature Medicine Closely
Nature Medicine's COMPARE phase 1 data on CD19 CAR T in refractory RA shows zero severe CRS in 6...
TALENTOP Proved Conversion Surgery Works in Advanced HCC. Now Comes the Harder Question.
TALENTOP's phase 3 data shows liver resection after atezo-bev nearly doubles time to treatment failure in advanced HCC. The...
What the KRYSTAL-12 Lancet Correspondence Actually Says About PRO Reporting in KRASG12C Trials
KRYSTAL-12's EQ-5D-5L scores looked similar between arms despite heavier GI toxicity with adagrasib, a gap in PRO depth that...