The FDA Just Rewired Alzheimer’s Trial Design, Most Sponsors Haven’t Caught Up Yet
FDA's approval of two blood-based Alzheimer's tests signals regulators now accept plasma biomarkers as primary endpoints, reshaping CNS trial...
Adaptive Clinical Trial Design
Proteomic Aging Clocks Enter Clinical Trials: What Sponsors Need to Know Before the FDA Does
Proteomic aging clocks are moving into clinical trials, but FDA surrogate endpoint standards and assay reproducibility gaps could stall...
When Phase 3 Fails Because of Trial Design, Someone Missed a Signal Months Earlier
AstraZeneca's HICKORY trial missed its primary endpoint not because efzimfotase alfa didn't work, but because the trial design did,...
Phage Therapy Trials Are Launching Without a Regulatory Playbook. That’s a Problem.
Phage therapy trials for drug-resistant UTIs are advancing with no FDA guidance document, here's why comparator selection and resistance...
Replication Is Dead. Corroboration Is the Standard Clinical Trials Must Meet Now.
The NEJM just reframed reproducibility in biomedical science, and every clinical trial sponsor still designing for repetition is building...
The Pragmatic Trial Has Been Hijacked. Here Is What It Was Actually Supposed to Do.
JAMA's 2026 editorial exposes how "pragmatic trial" has been stretched beyond recognition, threatening regulatory credibility and real-world evidence quality.
Amygdala Ultrasound in Depression: What the First Human Data Reveals About Neuromodulation’s Next Frontier
First-in-human trial targets the amygdala with focused ultrasound in MDD, raising hard questions about biomarker selection, endpoint design, and...
Giredestrant Plus Everolimus Just Cleared the Bar: What the evERA Data Actually Demands From Trial Designers
NEJM publishes evERA Breast Cancer trial data showing giredestrant plus everolimus superiority in HR+ advanced breast cancer, here's what...
The Brain-Wave Trial That Just Raised the Bar for Neuromodulation RCTs
A double-blind tACS trial targeting theta oscillations in methamphetamine patients sets a new design standard regulators will use to...
The AI That Eliminated Cold Chain from mRNA Vaccines Just Changed How You Design a Phase I
AGENT framework achieves 100% mRNA bioactivity after 2+ months at 37°C, forcing a rethink of cold-chain assumptions in vaccine...