The Utah Regional Network for Excellence in Neuroscience Clinical Trials

NIH RePORTER · NIH · U24 · $305,000 · view on reporter.nih.gov ↗

Abstract

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 increased startup efficiency. NeuroNEXT has completed 3 trials, with a 4th finishing an open label extension; 3 others are enrolling, 1 will begin enrolling 11/17, and 1 was just funded. Each of the 4 having finished enrollment did so on or ahead of time. Each shares rapid startup and excellent data accuracy/qualty. The Utah Regional site in the Network for Excellence in Neuroscience Clinical Trials (UR-NEXT) is the NeuroNEXT clinical research site serving the 5 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 Medical Center (PCMC) is the only children’s hospital and serves as partner. UR-NEXT also includes the Salt Lake City Veteran's Administration Medical Center (SLCVAMC), the anchoring center for VISN 19, and Shriners Children’s Hospital. UR-NEXT has access to essentially all patients in the region (8 million covered lives). Intermountain Health Care (IHC) is the largest health care system, operates PCMC in cooperation with UUH, and is a key research partner. 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 benefits from a close collaborative relationship with the NCATS funded Center for Clinical and Translational Science and Trial Innovation Center as well as numerous other resources. The UUH IRB is responsible for PCMC and the SLCVAMC and is willing to continue to participate in the NeuroNEXT cIRB. The Office of Sponsored Projects has a history of using master trial agreements, and has agreed to continue to do so for NeuroNEXT. During the first funding period UR-NEXT was highly engaged and successful, participating in 7/8 studies for which site selection has taken place (and has volunteered for nN109). UR-NEXT has been one of the highest enrolling sites with one of the fastest startup times. Dr. Smith, UR-NEXT PI, is also PI of NN108, the Topiramate for Cryptogenic Sensory Neuropathy (the TopCSPN Study), and a member of the NeuroNEXT Executive Committee. UR-NEXT will now include a new Career Enhancement Plan including support for a yearly UR-NEXT Fellowship which will be awarded to a promising early career faculty investigator int...

Key facts

NIH application ID
10208979
Project number
5U24NS107156-04
Recipient
UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
Principal Investigator
John Robinson Singleton
Activity code
U24
Funding institute
NIH
Fiscal year
2021
Award amount
$305,000
Award type
5
Project period
2018-07-01 → 2023-06-30