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.
Funded regional coordinating stroke centers in the network will have both clinical science excellence and specialized expertise in stroke management, a strong background in stroke research, and a proven ability to recruit stroke patients. Each regional stroke center will also have strong collaborative relationships between vascular neurology, emergency medicine, interventional neuroradiology, neurosurgery, neurointensive care, neuroimaging, stroke rehabilitation, and pediatric neurology, indicating a commitment to offer every eligible patient the opportunity to participate in a trial conducted through the Network. In addition, the Stroke Trials Network will include an active stroke research training program. All network stroke centers will be committed to increasing the value of clinical research data through an aggressive data sharing plan.
This FOA solicits applications for Regional Coordinating Stroke Centers for the Stroke Trials Network. Separate FOAs will be issued to solicit applications for the National Clinical Coordinating Center (RFA-NS-13-012) and the National Data Management Center (TBD).