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.
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.
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.
1. A two page CV
2. A description of the proposed project. It should have the following elements:
A cover sheet with the project title, your name, department, and campus address, and the title of the program you are responding to.
A brief description (no more than three pages in length) of the proposed project that includes the following sponsor-identified review criteria:
Additional pages may be added for references
Please be sure the project is identified on each page and number the pages.
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