Redefining feasibility in clinical trials: Collaborative approaches for improved site selection.

Background: This Site Feasibility Task Force convened to assess the complex and burdensome process of site feasibility in clinical trials. The objective was to create mutual understanding of challenges and provide suggestions for improving collaboration among sponsors, contract research organizations (CROs), and sites.

Methods: The task force was composed of representatives from sponsors, CROs and sites (43 % Sites, 20 % Site Networks, 10 % Small/mid-size sponsors, 10 % Small/mid-size CROs, 10 % Large sponsors, 7 % Large CROs).

Creation of a Proof-of-Concept 3D-Printed Spinal Lateral Access Simulator.

Background Minimally invasive lateral lumbar interbody fusion (LLIF) offers advantages over traditional approaches, providing indirect decompression of neural elements and deformity correction while avoiding many challenges and risks of anterior and posterior approaches. Mastering this technique requires a specialized team, advanced equipment, and sufficient case exposure. Current training is limited to the classic educational model, and alternative training methods such as cadaver labs can be inconvenient, inaccessible, expensive, and incompatible with intraoperative neuromonitoring (IONM) systems.