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NeuroNEXT: Network for Excellence in Neuroscience Clinical Trials


NeuroNEXT will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations.  The network includes multiple Clinical Sites, one Clinical Coordinating Center (CCC) and one Data Coordinating Center (DCC).

Network website: www.neuronext.org

You DO NOT need to be part of the NeuroNEXT infrastructure to apply to conduct a study within the network. Applications from academic investigators, advocacy groups/foundations, small businesses and the pharmaceutical industry are welcomed. 

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Plus Sign   Upcoming Events 

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Plus Sign   NeuroNEXT Network

  • NeuroNEXT Executive Committee (NEC)
    • Permanent members
      • CCC PI: Merit Cudkowicz, MD, MS
      • DCC PI: Christopher Coffey, PhD
      • NINDS Scientific Program Director: Elizabeth McNeil, MD, MS
    • Rotating members
      • Clinical Site PI representatives (2011-2014): Tracy Glauser, MD; E. Clarke Haley, MD; Karen Marder, MD, MPH
      • PIs of all approved NeuroNEXT studies (for study duration): Stephen Kolb, MD, PhD

  • Data Coordinating Center: University of Iowa
  • Clinical Coordinating Center: Massachusetts General Hospital
  • Clinical Sites
Plus Sign   How to Apply to NeuroNEXT 

NeuroNEXT is intended to facilitate the testing of novel therapeutics (drugs, biologics, devices) for neurological disorders. These novel therapeutics may come from academic investigators or directly from the biotechnology or pharmaceutical sector. NeuroNEXT aims to support scientifically sound phase 2 clinical trials that provide data for clear go/no-go decisions. Biomarker validation studies are also considered either independently or as part of a therapeutic trial.

Working with NeuroNEXT is a cooperative venture between NINDS, the NeuroNEXT network and the applicant. NINDS will provide guidance to potential applicants with input from the Office of Clinical Research (OCR), the applicable NINDS Extramural office/cluster and the NeuroNEXT Executive Committee (NEC). Potential applicants should contact NINDS OCR in order to discuss the feasibility of conducting the proposed trial through the NeuroNEXT infrastructure.

There are three mechanisms available for potential applicants:

  1. Academic investigators may apply for cooperative agreement grants: NeuroNEXT Clinical Trials (U01) (PAR-11-343).
  2. Industry may apply for expedited access to NeuroNEXT expertise and infrastructure through the NeuroNEXT Infrastructure Resource Access (X01) (PAR-11-344) under a cost-sharing arrangement and Cooperative Research and Development Agreement (CRADA) with NINDS.
  3. Small businesses may apply for cooperative agreement grants: NeuroNEXT Clinical Trials (U01) (PAR-11-343); OR through our Small Business program: NeuroNEXT Small Business Innovation in Clinical Trials (U44) (PAR-11-345).

Information for potential industry collaborators:

Information for potential advocacy collaborators:

Potential applicants whose clinical research cannot be supported through NeuroNEXT are encouraged to consider an alternate funding mechanism:

  • NINDS Exploratory Clinical Trials (PAR-10-199)
  • NINDS Phase III Investigator-Initiated Multi-Site Clinical Trials (PAR-11-173)

Plus Sign   Referral/review Process for NeuroNEXT Applications
  • Prospective applicant contacts NINDS/OCR to discuss the proposed trial
  • NINDS program staff, including the Office/Cluster which holds the disease of interest within its portfolio, will discuss the proposed trial
  • Trials which have good NINDS program support are referred to the NEC to assess network feasibility
  • Projects which have NINDS program support and are feasible for network performance are asked to submit a formal application for peer review by the NeuroNEXT SEP and subsequent consideration by the NINDS Advisory Council. The NeuroNEXT CCC will assist in protocol development in support of the formal application.

NeuroNEXT Clinical Trials (U01) - Standard dates apply for scientific merit review of applications coming under the U01 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-11-343.

NeuroNEXT Infrastructure Resource Access (X01) -   Expedited dates apply for scientific merit review of applications coming under the X01 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-11-344.

NeuroNEXT Small Business Innovation in Clinical Trials (U44) - Standard dates apply for scientific merit review of applications coming under the U44 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-11-345.



Plus Sign   Current NeuroNEXT-supported Studies


Contact:

Elizabeth McNeil, MD MSc
National Institute of Neurological Disorders and Stroke
Phone: (301) 496-9135
E-mail: mcneilde@ninds.nih.gov  or  NEXT@ninds.nih.gov

Questions? Please email NEXT@ninds.nih.gov

Last updated May 1, 2014