When the Primary Endpoint Moves After 283 Patients Are Already In
A mid-trial primary outcome amendment in a thrombectomy study reveals the operational chain reaction sites and sponsor clinops teams...
Why the First Scan Matters Most: IAG’s Romiesa Hagoug on Keeping Imaging Data Honest Across Multi-Site Trials
Romiesa Hagoug, Head of Project Management at Image Analysis Group (IAG), on what a site's first scan reveals, how...
The WILLOW Trial Didn’t Fail Enpatoran. The Endpoint Did.
WILLOW Cohort B's p=0.14 masked a 58% BICLA response at the lowest dose. The drug worked. The endpoint couldn't...
Inventiva’s Lanifibranor Faces Cash Runway Pressure Before Phase 3 MASH Data
Inventiva's lanifibranor faces cash runway pressure as it awaits Phase 3 MASH data readout. Enrollment pace will determine financing...
Innovent Expands Phase 3 MarsLight-11 Trial of IBI363/TAK-928 to Non-Squamous NSCLC
Innovent and Takeda expand the Phase 3 MarsLight-11 Trial to include non-squamous NSCLC patients, doubling the addressable population for...
Akeso Enrolls First Patient in Phase III Trial of Cadonilimab vs Nivolumab for Gastric Cancer
Akeso launches COMPASSION-37, a global Phase III trial of cadonilimab versus nivolumab for HER2-negative gastric cancer, testing dual checkpoint...
Platform Trials Are Rewriting the Rules of Evidence. Regulators Haven’t Caught Up.
Adaptive platform trials like REMAP-CAP enrolled 4,869 critically ill COVID patients across 300+ sites, but FDA's master protocol guidance...
Headlands Research Joins SCRS Global Impact Partner Program
Headlands Research joins SCRS Global Impact Partner program to address site sustainability and trial complexity challenges in clinical operations.
Kodiak Sciences to Report DAYBREAK Phase 3 Results for Zenkuda and KSI-501
Kodiak Sciences reports DAYBREAK Phase 3 results for Zenkuda and KSI-501 in wet AMD on September 28, testing non-inferiority...
Platform Trials Are Rewriting the Rules of Evidence Generation. Regulators Haven’t Caught Up.
Adaptive platform trials like RECOVERY and REMAP-CAP are transforming infectious disease research, but FDA and EMA guidance still lags...