National Institutes of Health

NIH: NINDS Stroke Trials Network - National Clinical Coordinating Center (U01)

Program Summary

The purpose of this funding opportunity announcement (FOA) is to invite applications to participate as a National Clinical Coordinating Center (NCC) for the NINDS Stroke Trials Network.  The primary goal of this network is to maximize efficiencies to develop, promote and conduct high-quality, multi-site exploratory phase 1, 2 and confirmatory phase 3 clinical trials focused on key interventions, as well as biomarker-validation studies that are immediately preparatory to trials, in stroke prevention, treatment, and recovery with the objective to have a balanced portfolio between all three approaches.  The network will include multiple regional coordinating stroke centers with strong collaborative relationships between vascular neurology, emergency medicine, interventional neuroradiology, neurosurgery, neurointensive care, neuroimaging, stroke rehabilitation, and pediatric neurology that is coordinated through separate National Clinical Coordinating and Data Management Centers.  Efficiency will be encouraged through the use of master trial agreements and a central IRB.  Clinical and basic scientists at the regional coordinating stroke centers will contribute to the development of network clinical trial applications for peer review, as well as planning for execution of NINDS-funded clinical trial applications from outside of the network, including trials that result from Collaborative Research and Development Agreements between the NINDS and Industry partners.  The Network will also be uniquely poised to rapidly collaborate with other existing networks, such as the NINDS Neurological Emergencies Treatment Trials Network (NETT) or international consortia to conduct larger, definitive trials of promising interventions for the treatment of stroke.

Eligibility 

Only one NCC application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. 

Investigators at the NCC institution are strongly encouraged to also apply for a RCC (see RCC in WINS) award (RFA-NS-13-011).  However, it is preferred that the NCC and a RCC at the same institution be led by separate PD/PI's to ensure that the NCC activities as well as the local RCC activities receive full attention.

Awards for a NCC and a National Data Management Center (DMC) will not be made to the same PD/PI to ensure that data analyses and data acquisition are performed independently.

Award Information

Cooperative agreement.  NIH intends to fund one (1) award under this FOA, corresponding to a total of $2,250,000 for fiscal year 2013. Future year amounts will depend on annual appropriations. The expected direct cost for individual awards is up to $1.5 M for 5 years.  The project period is limited to 5 years.

Internal Selection Procedure
 
The Office of the Vice President for Research and the Carver Collge of Medicine have established an internal review procedure to select the UI nominee. Applications will be reviewed according to the sponsor's selection criteria. Consideration will also be given to UI institutional strengths and strategic directions. Potential applicants must submit, using the preselection link below, the following information:
1. A two page CV
2. A description of the proposed project. It should have the following elements:
  1. Additional pages may be added for references
  2. Please be sure the project is identified on each page and number the pages.
The above materials must be submitted no later than 5:00 p.m. on Tuesday, March 26, 2013. The selected nominee will be asked to complete the full application package in accordance with the sponsor's deadline of Tuesday, June 4, 2013.

Proposal due for preselection03/26/2013 Not open for submission deadline passed
Date Due to Sponsor06/04/2013
Required LOI Due DateN/A
Non-Required LOI Due Date04/01/2013
Email:angie-robertson@uiowa.edu
Phone:319-353-3619
Sponsor URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-012.html

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