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NeuroNEXT Clinical Coordinating Center (CCC)

The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT ) consists of a Clinical Coordinating Center (CCC) at Massachusetts General Hospital, a Data Coordinating Center (DCC) at the University of Iowa, and 25 clinical sites throughout the country.

Overview

Network for Excellence in Neuroscience Clinical Trials

The Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry. Funded by the National Institutes of Health's National Institute of Neurological Disorders and Stroke (NINDS), NeuroNEXT was designed to:

  • Increase efficiency of clinical trials
  • Expand the capability of NINDS to test promising new therapies
  • Respond quickly as opportunities arise to test promising new treatments for people with neurological disorders

Working with NeuroNEXT is a cooperative venture between NINDS, the Network coordinating centers, and the academic, small business, or industry collaborator. The Network provides a robust, standardized, and accessible infrastructure to facilitate the rapid development and implementation of protocols in neurological disorders, in both adult and pediatric populations. The network includes clinical sites, a Clinical Coordinating Center, and a Data Coordinating Center.

About NeuroNEXT

The NeuroNEXT Network consists of a Clinical Coordinating Center (CCC) at Massachusetts General Hospital, a Data Coordinating Center (DCC) at the University of Iowa, and 25 clinical sites throughout the country. Since 2011, we have been working together to improve productivity and expedite therapy development for neurological disorders. Features of the Network, including a Central IRB and a standardized Master Trial Agreement, are designed to efficiently conduct Phase II Clinical Trials. Studies in the Network are expected to take advantage of the experienced CCC and DCC, who work with investigators through the life-cycle of their project, as well as the well-trained clinical sites located throughout the US. Our funding comes from the National Institute of Neurological Disorders and Stroke (NINDS), and we work closely with NINDS representatives in all of our undertakings.

Clinical Coordinating Center

Our Neurological Clinical Research Institute (NCRI), at Mass General Hospital serves as the NeuroNEXT Clinical Coordinating Center (CCC). The NCRI develops, designs, supports and manages innovative observational and interventional trials for neurological disorders. The NeuroNEXT CCC provides high-quality project management and regulatory coordination for all studies in the NeuroNEXT Network.

The NeuroNEXT CCC provides trial coordination, site management, protection of human subjects, and training and education for the all Network projects. The Study Design team at the CCC are experts in early phase clinical trial design and conduct, and works with the Protocol Principal Investigators of all NeuroNEXT projects on protocol design and budget development. In addition to providing high-quality project management and clinical coordination to all Network projects, our CCC works closely with the Central IRB to insure timely timely cIRB review and approval (initial and annual) as well as protocol amendments and safety reporting. The CCC also develops and maintains the Trial Master File structure and content for each project.

For more information, view our full website.

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