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...
Clinical Trial Integrity
The Validation Accords: Clinical Trials Are About to Learn What “Validated AI” Actually Means
Nature Medicine's Validation Accords push for a generative AI consensus framework, and expose a regulatory gap that could invalidate...
GCP Breakdown at King’s College Hospital Just Clouded the Most Promising Parkinson’s Trial in Years
An MHRA inspection at King's College Hospital flagged department-wide GCP failures in the exenatide Phase 3 Parkinson's trial, triggering...