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...
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...
Psychedelic Trials Are Effectively Open-Label. The FDA Has to Decide What to Do With That.
A meta-analysis of 112 psychedelic RCTs found >90% unblinding rates, meaning every efficacy estimate in the field may be...
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...
FDA’s May 2026 Leadership Exodus: What the Simultaneous CDER and CBER Vacancies Mean for Sponsor IND Strategy
With Makary out May 12 and acting CDER chief Høeg fired May 15, sponsors with pending NDAs and INDs...
Pediatric Oncology Keeps Getting Treated as an Afterthought. The Biology Disagrees.
Children with cancer wait 6.5 years longer than adults to access new drugs. Adaptive and tumor-agnostic designs can close...
Neurodegenerative Drug Development Has a 2% Success Rate. Platform Trials Are the Only Honest Response.
With 51% of Alzheimer's disease-modifying compounds failing Phase III, The Lancet's case for MAMS platform trials in neurology isn't...