Obesity Trials Are Optimized to Win Approval, Not to Predict Real-World Use
Nature Medicine's 2026 analysis exposes why obesity drug trials maximizing weight loss endpoints produce results that collapse on contact...
Nature Medicine’s June 2026 Benchmark Study Reveals General-Purpose LLMs Outperform FDA-Cleared Clinical AI — and Exposes a Validation Gap Regulators Have Not Closed
A Nature Medicine study finds GPT-5.2, Gemini 3.1 Pro, and Claude Opus 4.6 outperform FDA-cleared clinical AI tools on...
An Open Letter to Acting Commissioner Diamantas: The FDA Needs a Regulatory Pathway for Vaccine-Based Dementia Prevention Trials Now
Nature Medicine just made the case for large-scale RCTs of live-attenuated shingles vaccination for dementia prevention. Acting Commissioner Diamantas,...
Adaptive DBS Just Rewrote the Rules for CNS Trial Design — Is the FDA Ready?
A Nature Medicine randomized trial shows adaptive DBS cuts gait variability in Parkinson's. The real story is what its...
What the PRAC’s June 2026 Valproate Meeting Highlights Actually Say About Paternal Exposure Risk
EMA's PRAC found paternal valproate exposure evidence "inconsistent" with causal NDD risk in offspring — but still recommended precautionary...
Spatial CRISPR Screening Just Made Your Preclinical Models Look Like Guesswork
Nature Biotechnology's Perturb-DBiT maps CRISPR perturbations in native tissue — and exposes why dissociated-cell screens keep producing trials that...
Why Pilots Don’t Scale: The Case for Pre-Protocol Invariants in Clinical Development
A leading sponsor hit 79% site adoption and called it a ceiling. The fix isn’t better tools—it’s pre-protocol invariants...
The EMPHASIS Trial Correspondence Surfaces Three Trial Design Constraints That Will Shape the Next Neuroprotection Protocol
A Lancet correspondence on EMPHASIS identifies patient selection limits, generalisability gaps, and statistical design issues that every stroke trial...
Reading the SYNCHRONIZE-MASLD Phase 3 Trial Publication Closely
The SYNCHRONIZE-MASLD Phase 3 trial in Nature Medicine shows survodutide cutting liver fat by 64.3% vs placebo — here's...
The Neurological Drug Development Machine Is Broken. Platform Trials Are the Wrench.
MAMS platform trials could cut neurodegenerative drug timelines—but adaptive stopping rules and FDA guidance gaps threaten to stall the...