Trialect

Active

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

National Institutes of Health

This NOFO encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet . Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.

It is NINDS's intent that all NINDS-supported multi-center clinical trials in stroke treatment, recovery, or prevention will be conducted within the NIH StrokeNet. Only in exceptional circumstances will NINDS consider funding multi-site stroke clinical trials outside of this network.

This NOFO uses the bi-phasic, milestone driven UG3/UH3 cooperative agreement activity code. Awards made under this NOFO will initially support a one-year milestone-driven planning and start-up phase, with possible transition to an implementation (UH3) phase of up to 6 additional years. Only UG3 projects that meet the scientific milestones and award requirements of the UG3 phase may transition to the UH3 phase. Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are expected to include plans for project management and performance milestones for each phase.

Applicants do not need to be part of the existing NIH StrokeNet infrastructure to apply under this NOFO.

Deadlines:

New Applications : March 19, 2024; June 20, 2024; Oct 18, 2024; Feb 19, 2025; Jun 20, 2025; Oct 20, 2025; Feb 19, 2026; June 18, 2026; Oct 19, 2026
Resubmission or Revision Applications: March 19, 2024; July 19, 2024; Nov 19, 2024; March 19, 2025; July 18, 2025; Nov 19, 2025; March 19, 2026; July 20, 2026; Nov 19, 2026

PAR-24-101 Expiration Date November 20, 2026