The Utah Regional Network for Excellence in Neuroscience Clinical Trials (UR-NEXT)

Multicenter clinical trials face numerous challenges including recruitment, lack of clinical trial expertise, and inefficiencies in IRB approval and contracting. The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) has addressed these by organizing 25 research sites and central Data and Clinical Coordinating centers, each with significant expertise in clinical trial design and performance and access to a broad range of content experts. NeuroNEXT has a Central IRB (cIRB) and master trial agreement (MTA) that increases startup efficiency. NeuroNEXT has completed 8 trials, and three more are active. The Utah Regional site in the Network for Excellence in Neuroscience Clinical Trials (UR-NEXT) is the NeuroNEXT clinical research site serving the five state Intermountain West. UR-NEXT is centered at University Utah Health (UUH). UUH has the only integrated neuroscience center in the region. Primary Children's Hospital (PCH) is the only children's hospital and serves as partner. UR-NEXT also includes the Salt Lake City Veteran's Administration Health System (SLCVAHS), the anchoring center for VISN 19, and Intermountain Health Care (IHC), which operates PCH. Together these systems provide medical services to more than 80% of the 10 million covered lives in the region. UR-NEXT benefits from an established network of referring community neurologists with interest in clinical trials, the Western Intermountain Neurological Organization (WINO). The Neurology Department has Divisions in each major subspecialty with substantial expertise in the management and performance of multicenter trials. UR-NEXT shares leadership with, and benefits from a close collaborative relationship with the NCATS funded Utah Clinical and Translational Sciences Institute. UR-NEXT leadership and UUH programs provide deep expertise in rare diseases and genetic therapies that will benefit the NeuroNEXT consortium. The UUH IRB is responsible for PCH and VAHS, and leads cIRB development for the CTSA nationally, while the Office of Sponsored Projects has experience with master trial agreements. UR-NEXT has been highly engaged and successful as a NeuroNEXT site during this funding period. Utah participated in 5 of 6 protocols since 2017 and was the top enrollment site in two of the past four years, the fourth highest enrolling site over the NeuroNEXT lifespan, with 100% retention of participants during the current funding period. UR- NEXT led administration of NN-108, analyzed intraepidermal nerve fiber density as the co-primary endpoint and reviewed all study nerve conduction studies. Stacey Clardy is PDPI for NN-111 ExTINGUISH, an inpatient trial of inebilizumab for treatment of autoimmune encephalitis, which began enrolling in 2022. UR-NEXT includes a Career Enhancement Plan that supports a yearly UR-NEXT Fellowship which is awarded to a promising early career neurosciences faculty investigator interested in clinical trials. This program will benefit from alignment with robust existing career development resources available through the CTSI and UUH Vice President's office.