The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite currently awarded NIH StrokeNet centers AND potential new stroke centers to participate as a Regional Coordinating Stroke Center in the NIH StrokeNet clinical trials network. The goal of this existing 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 (NCC) and National Data Management Centers (NDMC).
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 NIH Stroke Trials Network will include an active stroke research career enhancement program. All network stroke centers will be committed to increasing the value of clinical research data through an aggressive data sharing plan.
In 2013, the NIH StrokeNet was established to conduct clinical trials in a centrally coordinated network that includes 25 regional centers that are linked to over 350 stroke hospitals across the United States. The NIH StrokeNet was designed to rapidly initiate and efficiently implement small and large multi-site exploratory and confirmatory clinical trials focused on promising interventions for stroke prevention, treatment and recovery, as well as validation studies of biomarkers or outcome measures. The network includes an education platform designed to train the next generation of stroke clinical researchers and collaborations from a variety of health professionals across multiple disciplines. The interdisciplinary nature of the NIH StrokeNet is expected to build research capabilities that match the scientific opportunities across the spectrum of stroke research. Additional information on the current structure of the network can be found at: www.nihstrokenet.org.
The aims of the network are to harness multidisciplinary stroke expertise to collaboratively and efficiently conduct exploratory NINDS-sponsored Phase 1/2 clinical trials for stroke interventions with the goal to quickly move potential treatments into larger, confirmatory Phase 3 trials. In addition, the network may perform biomarker validation studies that are immediately preparatory to clinical trial(s). Collaboration with international consortia will facilitate the execution of the larger, Phase 3 definitive trials. Together with the larger U.S. and the international stroke research community, stroke patients, and stroke-related nonprofit associations, the investigators at the RCC's will work to design and execute the most clinically impactful stroke research.
Study execution and performance will be monitored by the NINDS and the National Clinical Coordinating (NCC) and National Data Management (NDMC) Centers to ensure that all eligible stroke patients are considered for NINDS-funded trials.
The NINDS intends that the NIH StrokeNet will be the primary and first-line infrastructure involved in implementing all multi-site stroke trials submitted to the NINDS.
University is limited to one proposal.
|UIC Letter of Intent||
June 15, 2017
|UIC Internal Competition||
|Sponsor Letter of Intent||
September 25, 2017
Letter of Intent
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.