Lecanemab’s At-Home Start Dose Just Rewrote the Rules for Alzheimer’s Trial Design
FDA's July 2026 approval of at-home subcutaneous lecanemab initiation eliminates the 18-month IV requirement, reshaping CNS trial recruitment and...
CNS trial design
Psychiatry’s Stratification Crisis: How Biomarkers Are Finally Breaking the DSM’s Grip on Trial Design
Precision psychiatry biomarkers are reshaping CNS trial stratification — here's what the shift from symptom-based DSM criteria to biotype-driven...
The PTSD Nightmare Drug No One Expected: What Dronabinol’s RCT Tells Us About CNS Trial Design
A dronabinol RCT in Nature Medicine just outperformed prazosin's VA trial with 170+ PTSD patients. Here's what the trial...
The FDA Measures All Schizophrenia Symptoms at the Same Clock. A Six-Trial IPD Analysis Just Proved That’s Wrong.
A Lancet Psychiatry IPD meta-analysis of six antipsychotic trials shows hostility resolves weeks before negative symptoms—exposing a critical flaw...
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...