Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)

The National Institute of Neurological Disorders and Stroke (NINDS) is inviting applications for a limited competition funding opportunity (PAR-25-149) to support the renewal of existing clinical trial cooperative agreement (U01) awards. This initiative is specifically for projects requiring additional time and resources to complete ongoing NINDS-supported clinical trials. The funding is intended to ensure the completion of active trials without introducing new research aims beyond those originally approved. Applications that include new objectives will be deemed out of scope and excluded from review. Eligible applicants include recipients of cooperative agreement awards under previous NINDS funding announcements, such as PAR-17-102, PAR-18-422, and several StrokeNet Clinical Trial and Biomarker Studies NOFOs. This opportunity supports ongoing NINDS research focused on understanding the causes, mechanisms, and potential interventions for neurological disorders. Trials eligible for renewal should align with the NINDS mission, which includes advancing knowledge of brain and nervous system function, developing diagnostic and therapeutic methods, and training in neuroscience. Renewal applications should only request funding sufficient to complete the current trial as per its initial design and scope. The cooperative agreement model will allow NINDS scientific and program staff to play a substantial role in guiding and overseeing project activities. There is no budget limit for applications; however, requested budgets must reflect the actual requirements for trial completion. Awards can extend for up to five years, depending on the scope of the remaining work. Applications must detail a justified budget, including costs required for clinical trial activities not covered by other sources, with any third-party support documented. Budgets should primarily be structured on a fee-for-service basis, with per-patient costs itemized. Eligibility for this funding is limited to U.S.-based public institutions, non-profits, tribal organizations, and local governments. Eligible applicants must also have active registrations in systems such as SAM, eRA Commons, and Grants.gov before applying. Principal Investigators should have experience managing large, multi-center clinical trials and should be prepared to include biosketches of key personnel involved in trial management and data oversight. Required components include descriptions of trial significance, study status, rationale for renewal, any modifications made since the original award, and projected milestones for trial completion. Applications will be evaluated by NINDS using several review criteria, including the importance of the research, rigor and feasibility of the approach, and qualifications of the investigative team. Specific attention will be given to the trial’s scientific significance, its potential to impact clinical practice, and any new findings that justify the trial’s continuation. Rigor of design, recruitment feasibility, and the trial's progress to date will also be critically assessed. Important submission dates are March 5, July 5, and November 5 annually until the expiration on November 6, 2027. Applications are to be submitted via Grants.gov, with NIH ASSIST, institutional system-to-system solutions, or Grants.gov Workspace as submission options. Prior to applying, applicants seeking $500,000 or more in direct costs annually must contact an NINDS Scientific/Research contact at least six weeks in advance. For additional support, applicants can contact designated NIH staff for assistance with application processes, program-specific questions, and post-award administration. NINDS will maintain substantial involvement post-award, including periodic progress reviews and data and safety monitoring to ensure trial integrity. Recipients must also comply with NIH’s data management and sharing policy and adhere to specified ethical and reporting requirements.