NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)

The NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3) funding opportunity, issued by the National Institute of Neurological Disorders and Stroke (NINDS), supports multi-site exploratory and confirmatory clinical trials, biomarker validation studies, and ancillary studies related to stroke treatment, recovery, and prevention. The primary objective is to conduct these studies within the NIH StrokeNet infrastructure to leverage its resources and expertise. StrokeNet includes a National Clinical Coordinating Center, a National Data Management Center, and 27 Regional Coordinating Centers with approximately 500 affiliated stroke centers across the U.S. The program uses a phased cooperative agreement mechanism. The initial UG3 phase supports planning and study preparation for up to one year, while the UH3 phase, lasting up to six years, supports full trial implementation upon successful completion of UG3 milestones. Studies should address stroke prevention, acute treatment, or rehabilitation and recovery, employing innovative designs where possible. Exploratory studies should provide a pathway to future definitive trials, and biomarker studies should focus on validation for clinical trial readiness. Applicants are not required to be part of the existing NIH StrokeNet but must collaborate with the infrastructure if funded. The program encourages proposals for confirmatory trials to provide definitive answers about interventions, exploratory trials to test feasibility, and ancillary studies that build on existing StrokeNet research. Innovative study designs and diverse team involvement are emphasized to foster scientific advancement and inclusivity. There is no fixed limit on the award budget, but proposed budgets must reflect actual project needs. Projects must delineate milestones for each phase, and transition from UG3 to UH3 funding depends on meeting these milestones. Applications must include detailed budgets, including patient and protocol-specific costs. Collaborative agreements with StrokeNet resources, such as the National Data Management Center, are required for study implementation. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and government entities, though foreign organizations are not eligible to apply directly. Applicants must complete necessary registrations, including SAM, eRA Commons, and Grants.gov, prior to submission. Applications are due by designated dates, with the first submission deadline on February 19, 2025. Applicants should also submit a Clinical Protocol Synopsis and any documentation of regulatory approvals if applicable. Review criteria focus on the significance, innovation, rigor, feasibility, expertise, and resources of the proposed project. The NIH StrokeNet Steering Committee will prioritize high-scoring projects, and selected studies will be closely monitored for adherence to milestones and safety protocols. For additional details, applicants are encouraged to consult the NIH guidelines or contact the designated program officials.