NeuroNEXT Clinical Research Site at the University of Michigan

NIH RePORTER · NIH · U24 · $312,000 · view on reporter.nih.gov ↗

Abstract

The Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT), sponsored by NINDS, is designed to create infrastructure accelerating clinical trials for neurologic diseases in children and adults. This project will establish a Clinical Trials Site at the University of Michigan (UM) as part of the NeuroNext consortium. UM has a strong tradition in clinical neurosciences research, including clinical trials, and outstanding institutional resources to facilitate clinical trials. These include a centralized Clinical Trials Support Office, a robust pool of clinical research coordinators, strong institutional commitment to clinical trials, access to broad and diverse patient populations, and a diverse group of accomplished clinical investigators. These attributes qualify the University of Michigan as a productive NeuroNEXT site. Our goals as a NeuroNEXT site are to participate in a minimum of 4 NeuroNEXT trials over the course of the 5 year award, to provide substantial support for other NINDS sponsored trials, to coordinate our institutional resources at UM with the shared NeuroNEXT network infrastructure to increase efficiency, and to provide support and resources for clinical research training in order to develop the next generation of neurologic disease clinical trialists. To accomplish these goals, we will abide by a master clinical trial agreement and use a centralized IRB. The UM NeuroNEXT site will be led by two experienced Principal Investigators with track records in NINDS-, foundation- and pharmaceutical-supported clinical trials and will be administered by an Operating Committee. The Operating Committee will be responsible for the major decisions required in operating the UM NeuroNEXT program, including reviewing the approved clinical protocols received from NINDS, selecting the appropriate lead investigator among the UM NeuroNEXT site faculty to assume responsibility for the trial, providing the clinical and administrative support to conduct the trial rapidly and efficiently, as well as tracking and reporting trial performance to NINDS on a regular basis. A Training Program consisting of a mentorship program, a didactic learning experience, and clinical trial participation will also be part of the UM NeuroNEXT site to assist early stage clinical investigators in developing the skills needed to pursue careers in academic clinical research.

Key facts

NIH application ID
10439643
Project number
5U24NS107158-05
Recipient
UNIVERSITY OF MICHIGAN AT ANN ARBOR
Principal Investigator
KELVIN L CHOU
Activity code
U24
Funding institute
NIH
Fiscal year
2022
Award amount
$312,000
Award type
5
Project period
2018-07-15 → 2024-06-30