Opportunity Information: Apply for RFA NS 13 012
Apply for RFA NS 13 012
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Stroke Trials Network National Clinical Coordinating Center (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Feb 21, 2013 and posted on Feb 21, 2013.
- Applicants must submit their applications by Jun 4, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,250,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments County governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Private institutions of higher education Public housing authorities/Indian housing authorities.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The NINDS Stroke Trials Network National Clinical Coordinating Center (U01) funding opportunity (RFA-NS-13-012) is a National Institutes of Health cooperative agreement designed to stand up and run the central clinical operations hub for a nationwide stroke research network. The core aim is to make stroke clinical trials faster, more consistent, and more cost-effective by building shared infrastructure that multiple study teams can use, rather than reinventing processes for every new trial. The network is intended to support a steady pipeline of multi-site studies across the full stroke continuum, meaning prevention, acute treatment, and recovery/rehabilitation, while keeping a deliberately balanced portfolio across those three areas. In practice, this coordinating center role is about enabling high-quality exploratory Phase 1 and Phase 2 trials and confirmatory Phase 3 trials, along with biomarker validation projects that are immediately readying the field for subsequent trials.
A major emphasis of the announcement is efficiency and standardization across many clinical sites. The Stroke Trials Network is structured around multiple regional coordinating stroke centers, each built on strong, real-world collaborations among the clinical domains that routinely intersect in stroke care: vascular neurology, emergency medicine, interventional neuroradiology, neurosurgery, neurocritical care, neuroimaging, stroke rehabilitation, and pediatric neurology. The National Clinical Coordinating Center sits above and across these regional centers to help align procedures, timelines, documentation, and trial conduct. It is paired with a separate Data Management Center, reflecting a common NIH network model where operational coordination and data/statistical infrastructure are distinct but tightly linked.
The clinical coordinating center is expected to help the network develop, promote, and execute multi-site clinical trial applications that will go through peer review, and then to support the planning and execution of trials that NINDS funds both from within and outside the network. The announcement explicitly anticipates that not all trials will originate inside the network; the infrastructure should also be ready to take on NINDS-funded studies that come from external applicants. It also highlights the expectation that the network can support trials that arise from Collaborative Research and Development Agreements between NINDS and industry partners, which signals an intent to make the network attractive and usable for public-private translational efforts without compromising scientific rigor or regulatory compliance.
Another defining feature is the push toward streamlined regulatory and contracting approaches. The FOA calls out the use of master trial agreements and a central Institutional Review Board (IRB) as tools to reduce start-up time and administrative burden. In multi-site clinical trials, delays often come from negotiating separate contracts and repeating IRB review at each institution; these centralized mechanisms are meant to remove bottlenecks, speed site activation, and improve consistency in human subjects protections and protocol implementation.
The network is also positioned as an adaptable platform that can quickly scale and collaborate. The FOA notes that it should be uniquely capable of rapid collaboration with other established research networks, such as the NINDS Neurological Emergencies Treatment Trials Network (NETT), and with international consortia. This matters because definitive stroke trials often need large, diverse patient populations and fast enrollment, especially for time-sensitive acute stroke interventions. By having standing relationships, shared procedures, and ready-to-activate infrastructure, the coordinating center helps make larger, definitive studies more feasible when a promising intervention is ready for rigorous testing.
From an administrative standpoint, this opportunity was offered as a discretionary NIH cooperative agreement (U01), meaning NIH staff are expected to be substantially involved in the project’s direction, coordination, and oversight compared with a typical investigator-initiated grant. The FOA projected a single award (Expected Awards: 1) with an estimated total funding amount of $2,250,000. No cost sharing or matching was required. The opportunity was posted February 21, 2013, with an original and current closing date of June 4, 2013, and an archive date of July 5, 2013. The CFDA listing associated with it is 93.853, which covers extramural research programs in neurosciences and neurological disorders.
Eligibility was broad across U.S.-based organizations and governments. Eligible applicants included nonprofits (with and without 501(c)(3) status), public and private institutions of higher education, state and local governments (including counties, cities/townships, and special districts), independent school districts, tribal governments and tribal organizations (federally recognized and other than federally recognized), public housing authorities/Indian housing authorities, regional organizations, small businesses, and for-profit organizations other than small businesses. The FOA also explicitly included categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, as well as eligible federal agencies. Foreign institutions were not eligible, and non-U.S. components of U.S. organizations were not eligible; foreign components as defined by NIH policy were not allowed.
In plain terms, this grant was seeking one lead organization to serve as the clinical operations backbone of a national stroke trials enterprise: harmonizing multi-site trial execution, accelerating start-up through shared agreements and centralized oversight, coordinating a wide range of stroke-related specialties across regional centers, and ensuring the network can both generate its own trial concepts and efficiently run important trials that originate elsewhere, including those developed with industry collaboration or in partnership with other national and international research networks.
FAQs: NINDS Stroke Trials Network National Clinical Coordinating Center (U01) - RFA-NS-13-012
What is this funding opportunity?
This opportunity is the NINDS Stroke Trials Network National Clinical Coordinating Center (U01) funding opportunity (RFA-NS-13-012), a National Institutes of Health (NIH) cooperative agreement to establish and operate the central clinical operations hub for a nationwide stroke research network.
What is the main purpose of the National Clinical Coordinating Center?
The purpose is to make stroke clinical trials faster, more consistent, and more cost-effective by building shared, reusable infrastructure and standardized clinical operations that multiple study teams can use across many trials.
What does "U01 cooperative agreement" mean in this context?
A U01 is a discretionary NIH cooperative agreement. In this model, NIH staff are expected to be substantially involved in the project’s direction, coordination, and oversight, more so than in a typical investigator-initiated grant.
How many awards were expected?
The funding opportunity projected a single award (Expected Awards: 1).
What was the estimated total funding amount?
The estimated total funding amount was $2,250,000.
Was cost sharing or matching required?
No cost sharing or matching was required.
What areas of stroke research was the network intended to support?
The network was intended to support a steady pipeline of multi-site studies across the full stroke continuum: prevention, acute treatment, and recovery/rehabilitation, with a deliberately balanced portfolio across those three areas.
What kinds of studies was the network expected to enable?
The network was aimed at enabling high-quality exploratory Phase 1 and Phase 2 trials, confirmatory Phase 3 trials, and biomarker validation projects that are immediately readying the field for subsequent clinical trials.
How is the Stroke Trials Network structured?
The network is structured around multiple regional coordinating stroke centers. These regional centers are built on collaborations among clinical domains that commonly intersect in stroke care.
Which clinical specialties were emphasized in the regional collaborations?
The announcement highlighted collaborations spanning vascular neurology, emergency medicine, interventional neuroradiology, neurosurgery, neurocritical care, neuroimaging, stroke rehabilitation, and pediatric neurology.
What does the National Clinical Coordinating Center do relative to the regional centers?
The National Clinical Coordinating Center sits above and across the regional coordinating stroke centers to align procedures, timelines, documentation, and trial conduct across the network.
Is there a separate Data Management Center?
Yes. The National Clinical Coordinating Center is paired with a separate Data Management Center, reflecting a network model where operational coordination and data/statistical infrastructure are distinct but tightly linked.
Is the coordinating center only for trials created within the Stroke Trials Network?
No. The announcement explicitly anticipated that not all trials would originate inside the network. The infrastructure was expected to be ready to take on NINDS-funded studies that come from external applicants as well.
What is the coordinating center expected to do regarding clinical trial applications?
The coordinating center is expected to help the network develop, promote, and execute multi-site clinical trial applications that will go through peer review, and then support the planning and execution of trials that NINDS funds both from within and outside the network.
Does the opportunity mention industry collaboration?
Yes. The announcement highlights that the network should be able to support trials arising from Collaborative Research and Development Agreements between NINDS and industry partners.
Why does the announcement emphasize efficiency and standardization?
The emphasis is on reducing the time and cost associated with running multi-site trials by standardizing processes and using shared infrastructure, rather than repeatedly creating new processes for each individual trial.
What streamlined regulatory and contracting approaches were encouraged?
The FOA specifically called out the use of master trial agreements and a central Institutional Review Board (IRB) to reduce start-up time and administrative burden.
How do master trial agreements help in multi-site trials?
Master trial agreements are intended to reduce delays by avoiding repeated, site-by-site contract negotiations, helping speed trial start-up and site activation.
How does a central IRB help in multi-site trials?
A central IRB is intended to reduce delays and improve consistency by avoiding repeated local IRB reviews at each institution, while supporting consistent human subjects protections and protocol implementation across sites.
Can the network collaborate with other research networks?
Yes. The FOA notes the network should be uniquely capable of rapid collaboration with other established research networks, such as the NINDS Neurological Emergencies Treatment Trials Network (NETT), and with international consortia.
Why is rapid collaboration important for stroke trials?
Definitive stroke trials often need large, diverse patient populations and fast enrollment, especially for time-sensitive acute stroke interventions. Standing infrastructure and shared procedures can make large trials more feasible when an intervention is ready for rigorous testing.
When was the opportunity posted and when did it close?
The opportunity was posted on February 21, 2013. The original and current closing date was June 4, 2013.
What was the archive date?
The archive date was July 5, 2013.
What CFDA number is associated with this opportunity?
The CFDA listing associated with the opportunity is 93.853, which covers extramural research programs in neurosciences and neurological disorders.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations and governments. Eligible applicants included nonprofits (with and without 501(c)(3) status), public and private institutions of higher education, state and local governments (including counties, cities/townships, and special districts), independent school districts, tribal governments and tribal organizations (federally recognized and other than federally recognized), public housing authorities/Indian housing authorities, regional organizations, small businesses, and for-profit organizations other than small businesses.
Were specific institution types explicitly included?
Yes. The FOA explicitly included HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, as well as eligible federal agencies.
Were foreign institutions eligible?
No. Foreign institutions were not eligible.
Were non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations were not eligible.
Were foreign components (as defined by NIH policy) allowed?
No. Foreign components, as defined by NIH policy, were not allowed.
In plain terms, what was this grant seeking to fund?
It was seeking one lead organization to serve as the clinical operations backbone of a national stroke trials enterprise: harmonizing multi-site trial execution, accelerating start-up through shared agreements and centralized oversight, coordinating across many stroke-related specialties through regional centers, and ensuring the network can both generate its own trial concepts and efficiently run major NINDS-funded trials that originate elsewhere (including those involving industry collaboration or partnerships with other networks).
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