Program Summary

Program Summary

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NeuroNEXT sites and potential new sites to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies for neurological disorders, whether from academic, foundation or industry discoveries.  Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials. The network provides a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations.  While the network is not specific to one disease, it has the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities.  This FOA solicits applications for Clinical Sites. Separate FOAs solicit applications for the Clinical Coordinating Center and the Data Coordinating Center. 

 

Research Objectives

The network aims to share expertise and infrastructure across diseases, to leverage research resources at clinical sites, and to take advantage of clinical research opportunities as they arise in different disease areas.  Finite resources and – especially for rare diseases – a small pool of potential participants limit the number of large, confirmatory efficacy (Phase 3) trials that can be conducted at any given time.  Therefore, NINDS aims through the network to support exploratory trials and biomarker validation studies that can provide more rapid preliminary testing of new treatments.

The network also aims to streamline the implementation of clinical research by using standardized master trial agreements and infrastructure that utilizes a central IRB of record. 

While NINDS has historically funded trials to test drugs already approved for other indications, the network is designed to assure the broadest access to any new therapies for patients by carrying out trials coming from partnerships between NINDS and industry, foundations, or academia. These trials will be utilizing a variety of the NIH agreement mechanisms (e.g., Cooperative Research and Development Agreements [CRADAs]) that maximize industry participation and support.

It is envisioned that the network will not be "idle" at any time. During the periods of time when new network projects do not take up the entire capacity, the Clinical Site coordinators and Clinical Site principal investigators will improve the quality and facilitate the implementation of clinical trials at their sites, by offering their support to ongoing NINDS-funded trials and enhancing patient recruitment and retention. The CCC tracks site performance as it relates to ongoing NINDS-funded trials. During the initial period of support, the network has supported a total of 9 clinical trials, efficiently utilizing the available capacity. 

 

Budget: $200,000 in direct costs per year 

Application Limits

Application Limits

University is limited to one proposal.

Additional Information

Deadlines

UIC Letter of Intent
July 14, 2017
UIC Internal Competition
TBD
Sponsor Letter of Intent
N/A
Sponsor Application
September 1, 2017

Letter of Intent

Letter of Intent

Letter of Intent (LOI) Form

 

Depending upon the number of LOIs submitted, OVCR might be required to facilitate an internal peer review process to select UIC’s submission(s) to this program.  White paper instructions will distributed to those who have submitted LOIs.

 

Please contact Natalia Glubisz at RDS@uic.edu or 312-996-8348 with any questions.

 

If an authorized principal investigator is not listed above, please consider the limited competition still open. Contact RDS@uic.edu for further information.