The Bispecific Combination Wave Is Here: What the Englumafusp-Glofitamab Trial Signals for Hematology Trial Design
A Phase 1 trial pairing englumafusp alfa with glofitamab in B-cell NHL reveals a mechanistic shift reshaping how sponsors...
Adaptive Trial Design
The Trial You Never Have to Run: How Simulation Is Rewriting Clinical Development Economics
Nature Reviews Drug Discovery's 2026 simulation-guided trial framework shows sponsors how digital modeling can cut sample sizes 13–23% and...
The PARTNERS Trial Is Running a Clinical Experiment That Has Never Been Done Before. The World Is Watching.
The PARTNERS trial opened BVD enrollment July 2, 2026, testing MBP134 and obeldesivir for a hemorrhagic fever that kills...
The FDA’s Bayesian Guidance Arrives at Your Site Whether You’re Ready or Not
FDA's January 2026 Bayesian statistics draft guidance reshapes protocol design, interim analysis workflows, and site staffing budgets—here's what operators…
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FDA's January 2026 Bayesian draft guidance promises flexible trial designs — but adaptive interim triggers, real-time IRB amendments, and...
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...
The Trial Architecture Neurodegenerative Disease Has Always Needed — And Kept Refusing to Build
MAMS platform trials could end neurology's 99.6% drug failure rate. The Lancet just made the case. Here's what the...
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...