The FDA’s Bayesian Guidance Sounds Like Good News for Sponsors. Sites Will Feel It Differently.
FDA's January 2026 Bayesian draft guidance promises flexible trial designs — but adaptive interim triggers, real-time IRB amendments, and...
FDA Guidance
Adaptive DBS Just Ran a Randomized Trial on Gait. The Endpoints FDA Needs to Validate Next Are Nowhere in Current Guidance.
A Nature Medicine feasibility trial on adaptive deep brain stimulation for Parkinson's gait signals a regulatory gap: FDA has...
Decentralized Trials Are Everywhere. Nobody Agrees What They’re For.
DCTs promise faster enrollment and broader diversity, but sponsors, CROs, sites, and regulators each want something different—and the TELEPIK...
The Platform Trial Takeover: Neurology’s Last Best Chance to Stop Failing Patients
Multi-arm multi-stage platform trials could cut neurodegenerative drug timelines in half—but FDA adaptive design rules haven't caught up with...
Platform Trials Are Neurology’s Best Bet — So Why Is the FDA Still Treating Them Like Experiments?
The Lancet calls MAMS platform trials the fix for neurodegenerative drug failure. With 182 Alzheimer's trials active in 2025,...
The Neurodegenerative Trial Problem Has a Design Solution—But Sponsors Keep Ignoring It
MAMS platform trials could slash neurodegenerative drug development timelines—so why are sponsors still running serial Phase 2s for Alzheimer's...
The Cancer Nobody Saw Coming: What One Gene Therapy Tumor Tells Us About a Broken Safety Surveillance System
A rare gene therapy-linked cancer case exposes fatal gaps in long-term safety monitoring—and why FDA's 15-year follow-up mandate isn't...
One Cancer Case Is All It Takes: Why Gene Therapy’s Post-Market Safety Infrastructure Is Still Broken
A rare gene therapy-linked cancer case exposes the gap between FDA's 15-year CAR-T surveillance mandate and real-world monitoring systems...
6.4 Million Patients Can’t Be Wrong — But Can Regulators Read What This Validation Is Actually Saying?
A Nature Medicine validation of PREVENT and SCORE2 across 6.4M individuals offers a blueprint for RWE methodology that FDA...
The MASAI Trial Just Made AI-Augmented Mammography the Standard of Care. The FDA Hasn’t Noticed
The MASAI trial showed AI-plus-one-radiologist outperforms two radiologists in breast cancer screening. FDA's AI device framework still treats this...