SCRI and Merck Oncology Collaboration Falls Short on Activation Efficiency
SCRI's Accelero™ delivery model aims to expand patient access to oncology clinical trials at community-based sites across the US.
The collaboration with Merck deploys SCRI's delivery model across a network of over 200 locations in more than 20 states and approximately 1,500 oncology physicians.
However, site directors are left to navigate complex operational tasks despite having a network contract in place.
The site activation process involves multiple stages, including IRB submission, budget reconciliation, pharmacy qualification, lab certification, coordinator training, and system access for EDC and IRT.
The FDA's final guidance on decentralized clinical trial elements emphasizes that sponsors bear responsibility for ensuring site capabilities match the protocol's operational requirements.
SCRI and Merck must build site-specific readiness support into the activation process to truly compress the startup curve.