NIH SIREN Neurologic Clinical Trials (U01 Clinical Trial Required) | PAR 18 304

Opportunity Information: Apply for PAR 18 304

The NIH SIREN Neurologic Clinical Trials funding opportunity (PAR 18-304) is a National Institutes of Health (NIH) cooperative agreement mechanism (U01) designed to support rigorous, multi-center clinical trials that address neurological emergencies. The central idea is to move time-sensitive neurologic interventions forward by testing them in real-world emergency settings where rapid decision-making, streamlined workflows, and strong coordination across multiple hospitals and EMS-linked systems are essential. Because it is a "Clinical Trial Required" announcement, applications are expected to propose an actual interventional clinical trial rather than observational work or preliminary planning alone.

Projects funded through this announcement are expected to be conducted within the NIH StrokeNet / SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network) infrastructure. Investigators do not operate in isolation; instead, the proposed trial is carried out in collaboration with the established SIREN Network to take advantage of its readiness for emergency research, its experienced clinical sites, and its standardized processes. Awardees work closely with two core coordinating entities: the SIREN Clinical Coordinating Center (CCC) and the SIREN Data Coordinating Center (DCC). The CCC supports practical trial execution, helping ensure the study can be implemented efficiently across many sites (for example, aligning start-up activities, operational procedures, and site activation). The DCC provides statistical leadership and data management support, which typically includes study design input, randomization approaches, data capture systems, monitoring plans, and analysis support consistent with multi-site trial standards. On the ground, SIREN hubs and their affiliated clinical sites are the places where protocols are implemented and participants are enrolled and treated, meaning the network provides the operational footprint needed for enrollment in high-acuity, emergency contexts.

The opportunity sits within NIH's health research mission and is associated with multiple CFDA numbers (93.837, 93.838, 93.839, 93.853), reflecting that neurologic emergency trials can fall under several NIH institutes or program areas depending on the condition and intervention. The activity category is Health, and the instrument type is a cooperative agreement, which typically means NIH staff will have substantial programmatic involvement compared with a traditional research project grant. In practice, that usually translates into closer federal involvement in trial oversight, milestone-driven management, and a higher expectation of coordination with network governance and common SIREN procedures.

Eligibility is intentionally broad to encourage participation from many sectors capable of leading or partnering on emergency neurologic trials. Eligible applicants include a wide range of U.S. governmental entities (state, county, city/township, special districts), independent school districts, and public housing authorities/Indian housing authorities, as well as public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), tribal governments that are not federally recognized, eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This breadth signals NIH's intent to bring diverse institutions into high-impact emergency research, including organizations serving historically underrepresented communities and regions.

Administratively, the opportunity was created on 2017-10-03 and listed an original closing date of 2021-03-05. The posted record does not specify an award ceiling or the expected number of awards, which generally means those details would need to be confirmed in the full FOA text or related NIH budget guidance for the relevant receipt dates. Overall, the program is best understood as an NIH-supported pathway for launching and running definitive, multi-site neurologic emergency clinical trials using the established SIREN Network infrastructure, with built-in coordinating and data/statistical support to increase the likelihood that complex emergency trials can be executed quickly, consistently, and at scale.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH SIREN Neurologic Clinical Trials (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837, 93.838, 93.839, 93.853.
• This funding opportunity was created on 2017-10-03.
• Applicants must submit their applications by 2021-03-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 18 304

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