Scaling Clinical AI to One Million Patients Taught Us Things No Pilot Study Could
A Nature Medicine analysis of 1M+ patient AI deployments across three healthcare systems reveals the infrastructure gaps sponsors must...
When You Change the Endpoint at Month 12: What CHOICE-2 Got Right About Amendment Governance
CHOICE-2 changed its primary endpoint after 283 enrollments with no interim data released. Here's what that timeline reveals about...
MCP Connectors Move to Linux Foundation as Clinical Trials Begin Adoption
MCP connectors move to Linux Foundation governance as clinical trials begin adopting the standard for AI-integrated trial systems.
Advarra Proposes Three-Layer SIV Model to Reduce Training Burden
Advarra proposes a three-layer SIV model to streamline site initiation visits and reduce training overhead across clinical trial operations.
Actimed Completes Enrollment in PROACT Trial of S-Pindolol With Semaglutide
Actimed completes enrollment in PROACT trial of S-pindolol with semaglutide to evaluate muscle preservation during weight loss.
PDS0101 Plus Pembrolizumab Shows 39.3-Month Survival in HPV16 Head and Neck Cancer
PDS0101 Plus Pembrolizumab achieved 39.3-month median overall survival in HPV16-positive head and neck cancer, published in JAMA Oncology.
IMVT-1402 Misses Primary Endpoint in Cutaneous Lupus Proof-of-Concept Trial
IMVT-1402 missed its primary endpoint in a cutaneous lupus proof-of-concept trial, failing to show statistically significant improvement on CLASI-A...
Astellas Starts Phase 3 Trial of Setidegrasib vs Docetaxel in KRAS G12D Lung Cancer
Astellas launches Phase 3 trial comparing setidegrasib vs docetaxel in KRAS G12D lung cancer patients, targeting a previously untreated...
FDA Advisory Panel Votes 7-2 to Support Galleri Multi-Cancer Blood Test
FDA advisory panel votes 7-2 to support Galleri multi-cancer blood test, with the agency's final decision expected within months.
FDA Approves Lyrfigtu for FGFR2-Rearranged Cholangiocarcinoma
FDA approves Lyrfigtu for previously treated FGFR2-rearranged cholangiocarcinoma, offering a second-line option alongside established competitor pemigatinib.