The purpose of this funding opportunity announcement (FOA) is to invite applications to participate as a Regional Coordinating Stroke Center in the NINDS Stroke Trials Network. The primary goal of this network is to maximize efficiencies to develop, promote and conduct high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment, and recovery with the objective to have a balanced portfolio between all three approaches. Exploratory phase 1, 2 and confirmatory phase 3 clinical trials as well as biomarker-validation studies that are immediately preparatory to trials will be coordinated through separate National Clinical Coordinating and Data Management Centers. Additional efficiencies will be encouraged through the use of master trial agreements and a central IRB. Clinical and basic scientists at the centers will contribute to the development of network clinical trial applications for peer review, as well as planning for execution of NINDS-funded stroke 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 RCC application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
Awards for a NCC (see NCC in WINS) and a RCC may be made to the same institution. However, it is preferable that the NCC and the RCC grant at a given institution be awarded to two investigators, to ensure that the NCC activities as well as the local RCC activities receive full attention.
A RCC may be from a single institution or may include geographically or organizationally linked partners or satellite sites, such as other academic centers and/or private and community hospitals and clinics as needed to fulfill the research requirements; however, it is preferable that only one principle investigator be identified for the RCC application.
Cooperative agreement. NIH intends to fund an estimate of up to 25 awards, corresponding to a total of $8,750,000 for fiscal year 2013. Future year amounts will depend on annual appropriations. The maximum allowable direct cost per year for a NINDS Stroke Network clinical (hub) site will be $250,000. 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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