When the Primary Endpoint Changes Mid-Trial: The Amendment Playbook Sponsors Get Wrong
An intra-arterial alteplase trial changed its primary outcome at month 12 after 283 enrollments. Here's the clinops reality of...
The EPoS II Trial Just Made the 3-Year Colonoscopy Standard Look Like a Reflex, Not a Rule
EPoS II RCT finds 5-year colonoscopy surveillance noninferior to 3-year for high-risk adenoma patients, forcing a rethink of global...
Tekton Research Launches Dedicated Psychiatry Team Across 17 Sites
Tekton Research launches dedicated psychiatry team across 17 sites to address rater drift, diagnostic variability, and participant dropout in...
Vistagen’s fasedienol shows positive data in open-label extension for social anxiety disorder
Vistagen's fasedienol shows positive results in open-label extension for social anxiety disorder, following two Phase 3 primary endpoint misses.
CBL-514 Meets Primary Endpoint in Phase 2 Dercum’s Disease Trial
CBL-514 meets primary endpoint in Phase 2 Dercum's Disease trial, with 90% of patients achieving meaningful pain relief at...
Barzolvolimab Meets All Primary and Key Secondary Endpoints in Phase 3 CSU Trials
Barzolvolimab meets all primary and key secondary endpoints in Phase 3 CSU trials, advancing Celldex's mast cell-targeting treatment for...
Roche’s Sefaxersen Meets Primary Endpoint in Phase 3 IgAN Study
Roche's sefaxersen Phase 3 IgAN study met its primary endpoint, significantly reducing proteinuria versus placebo at 37 weeks in...
FDA Lifts Clinical Hold on Simufilam for TSC-Related Epilepsy Study
FDA lifts clinical hold on simufilam, enabling Filana to start Phase 2a proof-of-concept study in TSC-related epilepsy after nine-month...
The 90% Automation Promise Means Nothing to a Coordinator Running 12 Systems
Medable's CEO wants 90% of clinical trials automated by 2030. Site coordinators are still manually bridging 12 disconnected systems....
The Protocol-Only Coverage Analysis: What a Site Can Defend Before the Budget Arrives
A protocol-scoped MCA is a real deliverable, but it has hard limits. Here is what you can and cannot...