Opportunity Information: Apply for PAR 14 220
Apply for PAR 14 220
- 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 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on May 14, 2014 and posted on May 13, 2014.
- Applicants must submit their applications by Mar 5, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Public housing authorities/Indian housing authorities Independent school districts Special district governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses County governments.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity PAR-14-220, titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)," is a discretionary grant program offered by the National Institutes of Health, with leadership coming through the National Institute of Neurological Disorders and Stroke (NINDS). It uses the cooperative agreement mechanism (U01), which means projects are funded as a partnership: investigators lead the science, while NIH (and the StrokeNet infrastructure) plays an active role in helping plan, coordinate, and execute the work. The overall goal is to move promising stroke interventions and stroke-related measurement tools forward through well-designed, multi-site studies that can realistically influence clinical practice.
The FOA is aimed at two main types of projects. First, it encourages multi-site clinical trials, including both exploratory trials (often earlier-stage studies that refine feasibility, dosing, safety, recruitment approaches, or signals of efficacy) and confirmatory trials (more definitive studies intended to provide clear evidence of clinical benefit or lack of benefit). These trials can address the full stroke continuum, including prevention strategies, acute treatment approaches, and recovery/rehabilitation interventions after stroke. Second, the FOA supports biomarker studies or outcome-measure validation efforts, but specifically those that are "immediately preparatory" to clinical trials. In other words, the biomarker or measurement work should be positioned to directly enable or strengthen upcoming trials, such as by validating a surrogate endpoint, qualifying an imaging marker, improving patient selection, or establishing reliable and clinically meaningful outcome assessments.
A central feature of this opportunity is the potential to leverage NIH StrokeNet, a national clinical trials network built to make stroke research faster, more consistent, and more scalable across multiple sites. Access to StrokeNet is not automatic for every application. After peer review, NINDS plans to prioritize which of the highest-scoring, most compelling studies will be granted access to the StrokeNet infrastructure. This adds a practical, implementation-focused layer to the competition: applications not only need strong scientific merit, but also need to be suitable for efficient, network-based execution across multiple participating clinical sites.
If a project is selected for StrokeNet support, several dedicated StrokeNet components help carry it out. The StrokeNet National Coordinating Center (NCC) works with the funded investigators to implement the study efficiently, which can include operational coordination across sites, harmonization of procedures, and practical support to keep complex multi-site trials running smoothly. The National Data Management Center (NDMC) provides statistical and data management support, which is critical for trial design, randomization schemes, database development, data quality control, monitoring plans, and final analyses. In addition, StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites contribute recruitment and retention support and carry out on-site implementation of the clinical protocol, which helps address one of the most common failure points in large clinical trials: enrolling and keeping the right participants on schedule while maintaining consistent protocol adherence across locations.
In terms of who can apply, eligibility is broad and includes many U.S. and non-U.S. organizations. Eligible applicants listed include nonprofit organizations (both with and without 501(c)(3) status), public and private institutions of higher education, state and local governments (including counties, cities/townships, special districts), independent school districts, public housing authorities/Indian housing authorities, tribal governments and tribal organizations, small businesses, and other for-profit entities (including for-profits other than small businesses). The FOA also explicitly includes a range of institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. Importantly, foreign organizations and foreign institutions are eligible, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined by NIH policy) are allowed, which can be relevant for multi-national collaborations or specialized imaging/biomarker capabilities outside the United States.
Administratively, this opportunity falls under the NIH health research activity category and is associated with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It does not require cost sharing or matching. The FOA was posted in May 2014 and, as listed in the source details, had an original and current closing date of March 5, 2017, with an archive date of April 5, 2017, meaning it is no longer active as a current open competition in that historical form. The official announcement link provided for the archived FOA is http://grants.nih.gov/grants/guide/pa-files/PAR-14-220.html, and NIH’s Office of Extramural Research webmaster contacts are included for technical access or linking issues.
Taken together, this FOA is essentially a pathway for investigators to propose rigorously designed, multi-site stroke trials or trial-enabling biomarker/outcome validation studies, with the added advantage that top proposals may be able to run within NIH StrokeNet, benefiting from an established national coordination, data management and statistical core, and a network of regional centers and clinical sites geared toward efficient enrollment and standardized trial execution.
FAQs: NIH PAR-14-220 - NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)
What is PAR-14-220?
PAR-14-220 is an NIH funding opportunity announcement (FOA) titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)." It is a discretionary grant program led through the National Institute of Neurological Disorders and Stroke (NINDS).
What type of funding mechanism does this FOA use?
This FOA uses the U01 cooperative agreement mechanism. Under a cooperative agreement, investigators lead the scientific direction of the project, while NIH (and, when applicable, the NIH StrokeNet infrastructure) plays an active role in planning, coordinating, and carrying out the work.
What is the overall goal of this opportunity?
The goal is to move promising stroke interventions and stroke-related measurement tools forward through well-designed, multi-site studies that can realistically influence clinical practice.
What kinds of projects does PAR-14-220 support?
The FOA is aimed at two main categories: (1) multi-site clinical trials (including exploratory and confirmatory trials) across prevention, acute treatment, and recovery/rehabilitation; and (2) biomarker studies or outcome-measure validation efforts that are immediately preparatory to clinical trials.
What is meant by a multi-site clinical trial in this FOA?
Multi-site clinical trials are studies designed to be implemented across multiple clinical sites. The FOA supports both exploratory trials (often earlier-stage efforts focused on feasibility, dosing, safety, recruitment approaches, or signals of efficacy) and confirmatory trials (more definitive studies intended to provide clear evidence of clinical benefit or lack of benefit).
Which stages of stroke care can clinical trials address under this FOA?
Trials may address the full stroke continuum, including prevention strategies, acute treatment approaches, and recovery/rehabilitation interventions after stroke.
What types of biomarker or measurement projects are supported?
The FOA supports biomarker studies and outcome-measure validation efforts specifically when they are "immediately preparatory" to clinical trials. That means the biomarker or measurement work should be positioned to directly enable or strengthen upcoming trials.
What does "immediately preparatory to clinical trials" mean in practice?
Based on the FOA description, preparatory biomarker/measurement work is expected to directly support clinical trials by activities such as validating a surrogate endpoint, qualifying an imaging marker, improving patient selection, or establishing reliable and clinically meaningful outcome assessments.
What is NIH StrokeNet?
NIH StrokeNet is a national clinical trials network designed to make stroke research faster, more consistent, and more scalable across multiple sites. It can provide an established infrastructure for conducting complex, multi-site stroke studies.
Does every funded project automatically receive access to StrokeNet?
No. Access to the StrokeNet infrastructure is not automatic for every application. After peer review, NINDS plans to prioritize which of the highest-scoring and most compelling studies will be granted access to StrokeNet.
How does StrokeNet fit into the competition for this FOA?
In addition to strong scientific merit, applications need to be suitable for efficient, network-based execution across multiple participating clinical sites because NINDS plans to prioritize StrokeNet access for top proposals after peer review.
What StrokeNet components may support a selected project?
If a project is selected for StrokeNet support, the FOA describes several components that can help carry out the work: the StrokeNet National Coordinating Center (NCC), the National Data Management Center (NDMC), and StrokeNet Regional Coordinating Centers (RCCs) along with their affiliated clinical sites.
What does the StrokeNet National Coordinating Center (NCC) do?
The NCC works with funded investigators to implement the study efficiently. This can include operational coordination across sites, harmonization of procedures, and practical support to keep complex multi-site trials running smoothly.
What does the National Data Management Center (NDMC) do?
The NDMC provides statistical and data management support. As described, this support can include trial design input, randomization schemes, database development, data quality control, monitoring plans, and final analyses.
What role do StrokeNet Regional Coordinating Centers (RCCs) and clinical sites play?
RCCs and their affiliated clinical sites contribute recruitment and retention support and carry out on-site implementation of the clinical protocol. This is intended to help address common challenges in large multi-site trials, such as enrolling and retaining participants on schedule while maintaining consistent protocol adherence across locations.
Who is eligible to apply for PAR-14-220?
Eligibility is broad and includes many U.S. and non-U.S. organizations. Eligible applicants include nonprofit organizations (with or 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, public housing authorities/Indian housing authorities, tribal governments and tribal organizations, small businesses, and other for-profit entities (including for-profits other than small businesses).
Are specific types of institutions explicitly included?
Yes. The FOA explicitly includes institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Are foreign organizations eligible to apply?
Yes. Foreign organizations and foreign institutions are eligible. The FOA also states that non-U.S. components of U.S. organizations are eligible and that foreign components (as defined by NIH policy) are allowed.
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.853, "Extramural Research Programs in the Neurosciences and Neurological Disorders."
When was this FOA posted and is it still active?
The FOA was posted in May 2014. The listed closing date was March 5, 2017, and the archive date was April 5, 2017. Based on those dates, it is no longer active as an open competition in that historical form.
Where can the official (archived) FOA announcement be found?
The archived FOA announcement is available at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-220.html
Who is the lead NIH institute for this opportunity?
Leadership for this FOA comes through the National Institute of Neurological Disorders and Stroke (NINDS).
What should an applicant keep in mind about study implementation under this FOA?
The FOA emphasizes well-designed, multi-site studies with practical potential to influence clinical practice. It also highlights that, for studies prioritized for StrokeNet access after peer review, the work should be suitable for coordinated, network-based execution across multiple sites.
Is this opportunity focused only on clinical trials?
No. While a major focus is multi-site clinical trials, the FOA also supports biomarker studies and outcome-measure validation efforts as long as they are immediately preparatory to clinical trials.
What kinds of technical help are mentioned for access or linking issues?
The source details indicate that NIH Office of Extramural Research webmaster contacts are included for technical access or linking issues.
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