Opportunity Information: Apply for PAR 17 274
The NIH grant opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)" (Funding Opportunity Number PAR-17-274) is a cooperative agreement designed to support clinical research that can be carried out across multiple sites through the NIH StrokeNet network. The main goal is to move promising stroke-related interventions forward by funding both exploratory and confirmatory clinical trials, along with biomarker or outcome-measure validation studies that are positioned as immediate precursors to clinical trials. In practical terms, the program is aimed at studies that are ready to be implemented in a real-world, multi-center setting and that can generate evidence to improve stroke prevention, acute treatment, and recovery/rehabilitation.
A defining feature of this announcement is that funded projects are expected to operate within the NIH StrokeNet infrastructure rather than as standalone trials. StrokeNet is a national clinical trials network built to speed up stroke research by relying on an established coordinating structure and a set of ready-to-activate clinical sites. After applications undergo peer review, the National Institute of Neurological Disorders and Stroke (NINDS) plans to prioritize which of the top-scoring proposals will actually be run through StrokeNet, meaning that strong scientific merit is necessary but network prioritization is also a key step in determining which trials move forward.
Because this is a U01 cooperative agreement, investigators should expect substantial NIH involvement beyond typical grant oversight. The NIH StrokeNet National Coordinating Center (NCC) is positioned as an operational partner that will work closely with awardees to implement studies efficiently, which can include support for study start-up, regulatory coordination, and harmonizing procedures across sites. In parallel, the National Data Management Center (NDMC) provides statistical expertise and data management infrastructure, supporting the design and execution of analyses as well as secure, standardized handling of trial data. Recruitment and on-the-ground execution are supported through StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which help with participant enrollment and retention and with consistent protocol implementation at each site. Altogether, the opportunity is structured to reduce common bottlenecks in multi-site stroke research by pairing funded investigators with an existing national backbone for trial operations, data, and site performance.
The scientific scope is broad within stroke, spanning prevention, treatment, and recovery. Trials may be exploratory, intended to generate early evidence about a promising intervention, or confirmatory, intended to more definitively test efficacy and safety across a larger and more diverse patient population. The FOA also explicitly welcomes biomarker or outcome-measure validation studies when they are directly and immediately preparatory to trials, signaling interest in tools that can improve trial readiness, patient selection, stratification, monitoring, or endpoint assessment. These preparatory studies are meant to be closely tied to near-term clinical testing rather than long-range basic discovery.
Eligibility is intentionally expansive and includes a wide range of public, private, nonprofit, and for-profit entities. Eligible applicants listed include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, as well as other categories. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). This wide eligibility reflects an intent to draw strong clinical trial concepts from many sectors while leveraging the centralized StrokeNet platform to run the studies.
Administratively, the opportunity falls under the National Institutes of Health, with an activity category in health and a CFDA listing of 93.853. The funding instrument is a cooperative agreement (U01), reinforcing that awardees will be working in a collaborative model with NIH and the StrokeNet coordinating components rather than operating completely independently. The original closing date shown for the opportunity is January 7, 2018, and the record creation date is May 10, 2017. The source information provided does not specify an award ceiling or the expected number of awards, so applicants would typically rely on the full FOA text and NIH guidance for budget parameters and likely funding levels.
Overall, this FOA is best understood as a pathway for investigators to propose stroke clinical trials or trial-ready biomarker/outcome validation studies that can be executed efficiently at scale using the NIH StrokeNet national network. It emphasizes multi-site readiness, operational collaboration, and the expectation that well-scored projects will be further prioritized by NINDS for execution within StrokeNet, with coordinated support for implementation, recruitment, data management, and statistical analysis through the network's established centers.Apply for PAR 17 274
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on 2017-05-10.
- Applicants must submit their applications by 2018-01-07. (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.
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FAQs: NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01) - PAR-17-274
What is this funding opportunity?
This is an NIH grant opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)" with Funding Opportunity Number PAR-17-274. It uses the U01 cooperative agreement mechanism to support stroke-related clinical research conducted across multiple sites using the NIH StrokeNet network.
Which NIH institute is associated with this opportunity?
The opportunity is associated with the National Institutes of Health (NIH), and the National Institute of Neurological Disorders and Stroke (NINDS) is specifically described as prioritizing which peer-reviewed proposals will be run through StrokeNet.
What is the main goal of the program?
The main goal is to move promising stroke-related interventions forward by funding multi-site clinical trials (both exploratory and confirmatory) and biomarker or outcome-measure validation studies that are positioned as immediate precursors to clinical trials. The intent is to generate evidence that can improve stroke prevention, acute treatment, and recovery/rehabilitation.
What types of studies are supported under this FOA?
The FOA supports:
- Exploratory clinical trials intended to generate early evidence about promising interventions
- Confirmatory clinical trials intended to more definitively test efficacy and safety across a larger and more diverse patient population
- Biomarker or outcome-measure validation studies, when they are directly and immediately preparatory to clinical trials
What does "biomarker or outcome-measure validation" mean in this context?
In this announcement, biomarker or outcome-measure validation studies are described as studies that help ensure tools are ready for near-term clinical testing. They are intended to improve trial readiness (for example, patient selection, stratification, monitoring, or endpoint assessment) and must be positioned as immediate precursors to clinical trials rather than long-range basic discovery.
Is this opportunity limited to a single site, or does it require multiple sites?
The opportunity is designed for clinical research that can be carried out across multiple sites through the NIH StrokeNet network. The emphasis is on studies that are ready to be implemented in a real-world, multi-center setting.
Do funded studies run independently, or through NIH StrokeNet?
Funded projects are expected to operate within the NIH StrokeNet infrastructure rather than as standalone trials. StrokeNet provides a national clinical trials network with a coordinating structure and ready-to-activate clinical sites.
What is the NIH StrokeNet network?
NIH StrokeNet is described as a national clinical trials network built to speed up stroke research by using an established coordinating structure and a set of ready-to-activate clinical sites for multi-center stroke studies.
What does U01 cooperative agreement mean for applicants and awardees?
A U01 is a cooperative agreement, which means investigators should expect substantial NIH involvement beyond typical grant oversight. The announcement describes StrokeNet components as operational partners that work closely with awardees on implementing studies efficiently.
What kinds of NIH involvement are described for this cooperative agreement?
The FOA describes substantial involvement through StrokeNet coordinating components, including operational partnership, study start-up support, regulatory coordination, harmonizing procedures across sites, statistical expertise, and standardized data management support.
What is the role of the StrokeNet National Coordinating Center (NCC)?
The StrokeNet National Coordinating Center (NCC) is described as an operational partner that works closely with awardees to implement studies efficiently. This can include support for study start-up, regulatory coordination, and harmonizing procedures across sites.
What is the role of the National Data Management Center (NDMC)?
The National Data Management Center (NDMC) is described as providing statistical expertise and data management infrastructure. It supports the design and execution of analyses and provides secure, standardized handling of trial data.
What is the role of Regional Coordinating Centers (RCCs) and affiliated clinical sites?
StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites are described as supporting recruitment and on-the-ground execution. They help with participant enrollment and retention and with consistent protocol implementation at each site.
How does this FOA try to reduce common bottlenecks in multi-site stroke research?
The FOA is structured to reduce bottlenecks by pairing funded investigators with an existing national backbone for trial operations, data management, statistical support, and site performance, rather than requiring each project to build these capabilities from scratch.
What stroke research areas are within the scientific scope?
The scientific scope is broad within stroke and spans prevention, treatment, and recovery/rehabilitation.
Does a strong peer review score guarantee the trial will run in StrokeNet?
No. The announcement indicates that after peer review, NINDS plans to prioritize which of the top-scoring proposals will actually be run through StrokeNet. This means strong scientific merit is necessary, but network prioritization is also a key step in determining which trials move forward.
Who is eligible to apply?
Eligibility is described as intentionally expansive. Eligible applicants listed include public, private, nonprofit, and for-profit entities across many categories.
What kinds of government applicants are eligible?
Eligible government-related applicants listed include state, county, and local governments, as well as special district governments.
Are educational institutions eligible?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education. The announcement also highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, and TCCUs.
Are tribal entities eligible?
Yes. The listed eligible applicants include federally recognized Native American tribal governments and tribal organizations that are not federally recognized governments, as well as Tribally Controlled Colleges and Universities (TCCUs).
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. The eligible applicant list includes nonprofits with and without 501(c)(3) status.
Are for-profit organizations eligible?
Yes. The eligible applicant list includes for-profit organizations (other than small businesses) and also includes small businesses.
Are faith-based or community-based organizations eligible?
Yes. The announcement highlights faith-based or community-based organizations among additional eligible applicants.
Are federal agencies eligible to apply?
Yes. The announcement explicitly includes eligible federal agencies among additional eligible applicants.
Are U.S. territories or possessions eligible?
Yes. The announcement includes U.S. territories or possessions among additional eligible applicants.
Are non-U.S. (foreign) organizations eligible?
Yes. The announcement states that non-U.S. entities (foreign organizations) are included among eligible applicants.
What is the funding instrument and activity type?
The funding instrument is a cooperative agreement (U01). The activity category is described as health.
What CFDA number is associated with this opportunity?
The CFDA listing provided is 93.853.
What are the key dates provided?
The original closing date shown is January 7, 2018. The record creation date is May 10, 2017.
Does the provided information include the award ceiling or number of awards?
No. The source information provided does not specify an award ceiling or the expected number of awards.
What is the practical "fit" this FOA is looking for?
The program is aimed at studies that are ready to be implemented in a real-world, multi-center setting and that can generate evidence to improve stroke prevention, acute treatment, and recovery. Biomarker or outcome validation projects are expected to be trial-ready and directly tied to near-term clinical testing.
How should applicants think about the relationship between their study and StrokeNet operations?
Based on the description, applicants should expect their study to be carried out using StrokeNet infrastructure, with coordinated operational support from the NCC, statistical and data support from the NDMC, and recruitment and site execution support through RCCs and affiliated clinical sites.
What is the overall purpose of using StrokeNet for these awards?
The overall purpose is to speed up multi-site stroke research by using an established national network that can support efficient study implementation, consistent procedures across sites, coordinated recruitment, and standardized data and analysis approaches.
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