Opportunity Information: Apply for PAR 14 253
Apply for PAR 14 253
- 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 Infrastructure Resource Access (X01)" 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 Jun 13, 2014 and posted on Jun 6, 2014.
- Applicants must submit their applications by Jul 12, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses 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 Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Organizations) Non domestic (non U.S.) Entities (Foreign Institutions) are 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 allowed.
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Opportunity Summary:
The NIH opportunity titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01)" (Funding Opportunity Number PAR-14-253) is designed to give qualified applicants a structured way to use the NIH StrokeNet national research infrastructure to run multi-site stroke studies. Rather than functioning like a traditional grant that pays for the entire study, this mechanism focuses on providing access to an existing, coordinated network that can make large, multi-center stroke research faster and more consistent, especially when recruitment, standardized implementation, and high-quality data management are critical.
At its core, the program encourages applications for two broad categories of projects. The first category is multi-site exploratory and confirmatory clinical trials that test promising interventions related to stroke prevention, acute treatment, or recovery. The second category is biomarker or outcome-measure validation studies that are directly preparatory to clinical trials, meaning the work should be immediately useful for enabling or strengthening a near-term trial (for example, validating a biological marker, imaging marker, or clinical outcome tool that could be used as an endpoint or stratification method in subsequent stroke trials). The emphasis throughout is on studies that fit within the StrokeNet mission and can benefit from being executed across multiple sites with consistent procedures.
A major feature of this FOA is that access to StrokeNet is competitive and based on peer review. After applications are reviewed, the National Institute of Neurological Disorders and Stroke (NINDS) plans to prioritize giving StrokeNet access to proposals that score most highly. In practical terms, this means an applicant is not only proposing a scientifically sound study but is also requesting entry into a national platform that has established coordinating and operational capabilities specifically built for stroke research. If selected, the applicant does not simply receive a name on a list of sites; they receive support from StrokeNet components that are intended to reduce friction in start-up and execution while maintaining rigorous trial conduct.
The infrastructure support is delivered through several core StrokeNet entities with distinct roles. The StrokeNet National Coordinating Center (NCC) works with successful applicants to implement the study efficiently, which typically includes operational coordination, harmonizing processes across sites, and helping move a protocol from planning into active execution. The National Data Management Center (NDMC) provides statistical and data management support, which can include building and maintaining study databases, supporting data quality and monitoring processes, and contributing statistical expertise that is essential for multi-site trials and validation studies. In addition, the Regional Coordinating Centers (RCCs) and their affiliated clinical sites provide hands-on recruitment and retention support and handle on-site implementation of the clinical protocol, which is often one of the most challenging parts of stroke trials given time-sensitive enrollment, heterogeneous patient populations, and the need for consistent clinical workflows.
Another important element is that StrokeNet is positioned to collaborate with other major networks when a study requires broader reach or specialized emergency-research capabilities. The FOA specifically notes the potential to collaborate with the NINDS Neurological Emergencies Treatment Trials Network (NETT) and also with other U.S. and international consortia when larger, definitive trials are needed. This matters because many stroke interventions ultimately require large sample sizes, rapid enrollment pathways, and diverse site participation to produce generalizable, practice-changing evidence. By anchoring projects inside StrokeNet, investigators may be better able to scale from preparatory validation work or smaller confirmatory efforts into larger pivotal trials.
In terms of what the award does and does not cover, the X01 mechanism here is best understood as an infrastructure access pathway. Successful applicants may be granted access to StrokeNet resources, but they are expected to cover the clinical trial costs that are not already covered by the separate infrastructure awards supporting the NCC, NDMC, and RCCs. In other words, NIH is offering the platform (coordinating, data, and site network functions) while the applicant must bring or secure the funding needed for the remaining study costs. This structure is meant to maximize the use of an existing national capability while ensuring that the direct costs of running a particular trial are appropriately supported by the study sponsor or the applicant's broader funding plan.
Eligibility under the announcement is broad and includes small businesses, for-profit organizations (including those other than small businesses), and nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities). The FOA also allows foreign organizations and foreign institutions to apply, and foreign components as defined by NIH policy are allowed. However, it specifies that non-U.S. components of U.S. organizations are not eligible to apply, which is a nuance that can matter for U.S.-based institutions with overseas branches. There is no cost-sharing or matching requirement listed for the opportunity.
Administratively, this is a discretionary grant opportunity from the National Institutes of Health in the health area, associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The posting date was June 6, 2014, with creation on June 13, 2014, and the opportunity was ultimately archived in 2017 (original closing date September 7, 2017; current closing date July 12, 2017; archive date August 11, 2017). The full announcement was available through the NIH Grants Guide at the link provided in the notice (http://grants.nih.gov/grants/guide/pa-files/PAR-14-253.html), and NIH Office of Extramural Research (OER) webmaster contacts were listed for technical access issues.
Overall, the point of PAR-14-253 is to connect strong, peer-reviewed stroke clinical trial and biomarker validation proposals with an established national stroke research infrastructure that can accelerate start-up, improve consistency across sites, strengthen recruitment and retention, and support high-quality data management and statistical oversight. It is best suited for applicants who already have a credible plan to fund the non-infrastructure costs of their study and who want to leverage StrokeNet to run multi-site work that is ready for execution and aligned with stroke prevention, treatment, or recovery priorities.
FAQs: NIH StrokeNet Infrastructure Resource Access (X01) - PAR-14-253
What is the NIH opportunity PAR-14-253 (X01) designed to do?
PAR-14-253, titled "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01)," is designed to provide qualified applicants with a structured way to access and use the NIH StrokeNet national research infrastructure to conduct multi-site stroke studies. It focuses on infrastructure access rather than serving as a traditional grant that funds the entire study.
Is this a traditional grant that pays for the full study?
No. The X01 mechanism described here is best understood as an infrastructure access pathway. Successful applicants may receive access to StrokeNet resources, but they are expected to cover study costs that are not already covered by the separate infrastructure awards supporting StrokeNet components (such as the NCC, NDMC, and RCCs).
What types of projects does this FOA encourage?
The FOA encourages two broad categories of projects: (1) multi-site exploratory and confirmatory clinical trials evaluating interventions related to stroke prevention, acute treatment, or recovery; and (2) biomarker or outcome-measure validation studies that are directly preparatory to clinical trials, meaning the work should be immediately useful for enabling or strengthening a near-term trial.
What is meant by "directly preparatory to clinical trials" for biomarker or validation studies?
It means the biomarker or outcome-measure work should be immediately useful for enabling or strengthening a near-term clinical trial. Examples described include validating a biological marker, imaging marker, or a clinical outcome tool that could later be used as an endpoint or as a method for stratifying participants in subsequent stroke trials.
Why does this FOA emphasize multi-site studies?
The opportunity is built around NIH StrokeNet, a coordinated national network intended to make large, multi-center stroke research faster and more consistent. It is particularly relevant when recruitment, standardized implementation, and high-quality data management are critical and benefit from consistent procedures across multiple sites.
How is access to StrokeNet awarded under this FOA?
Access to StrokeNet is competitive and based on peer review. After applications are reviewed, the National Institute of Neurological Disorders and Stroke (NINDS) plans to prioritize providing StrokeNet access to proposals that score most highly.
What does it mean to be selected for StrokeNet access?
If selected, an applicant gains entry into an established national platform with coordinating and operational capabilities built for stroke research. The support is intended to reduce friction in study start-up and execution while maintaining rigorous trial conduct across multiple sites.
Which StrokeNet entities provide support, and what do they do?
The FOA describes several core entities: the StrokeNet National Coordinating Center (NCC), which helps implement the study efficiently and coordinates operations across sites; the National Data Management Center (NDMC), which provides statistical and data management support (including databases and data quality/monitoring support); and the Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which support recruitment and retention and conduct on-site protocol implementation.
What kinds of support might the National Coordinating Center (NCC) provide?
The NCC works with successful applicants to implement the study efficiently. This typically includes operational coordination, harmonizing processes across sites, and helping move a protocol from planning into active execution.
What kinds of support might the National Data Management Center (NDMC) provide?
The NDMC provides statistical and data management support. This can include building and maintaining study databases, supporting data quality and monitoring processes, and contributing statistical expertise that is essential for multi-site trials and validation studies.
What role do Regional Coordinating Centers (RCCs) and clinical sites play?
RCCs and affiliated clinical sites provide hands-on recruitment and retention support and handle on-site implementation of the clinical protocol. The FOA highlights that recruitment and consistent clinical workflows can be especially challenging in stroke trials, making this site network function particularly important.
Does StrokeNet ever collaborate with other networks under this FOA?
Yes. The FOA notes that StrokeNet is positioned to collaborate with other major networks when broader reach or specialized emergency-research capabilities are needed. It specifically mentions potential collaboration with the NINDS Neurological Emergencies Treatment Trials Network (NETT), as well as other U.S. and international consortia for larger, definitive trials.
Why is collaboration with NETT or other consortia mentioned as important?
Many stroke interventions require large sample sizes, rapid enrollment pathways, and diverse site participation to produce generalizable evidence. The FOA suggests that anchoring projects in StrokeNet can help studies scale from preparatory validation work or smaller confirmatory efforts into larger pivotal trials, potentially supported by collaborations when needed.
What costs are applicants expected to cover themselves?
Applicants are expected to cover clinical trial costs that are not already covered by the separate infrastructure awards supporting StrokeNet components (NCC, NDMC, and RCCs). In practical terms, NIH is offering access to the platform and network functions, while the applicant must bring or secure funding for the remaining study-specific costs.
Is there a cost-sharing or matching requirement?
No cost-sharing or matching requirement is listed for this opportunity.
Who is eligible to apply?
Eligibility is broad and includes small businesses, for-profit organizations (including those other than small businesses), and nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities). Foreign organizations and foreign institutions may apply, and foreign components (as defined by NIH policy) are allowed.
Are any applicants specifically not eligible?
Yes. The FOA specifies that non-U.S. components of U.S. organizations are not eligible to apply. This may matter for U.S.-based institutions that have overseas branches or components.
Which NIH institute is associated with prioritization decisions for StrokeNet access?
The FOA states that NINDS plans to prioritize giving StrokeNet access to proposals that score most highly after peer review.
What is the Funding Opportunity Number and program title?
The Funding Opportunity Number is PAR-14-253, and the title is "NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01)."
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was this opportunity posted and what is its current status?
The posting date was June 6, 2014, and it was created on June 13, 2014. The opportunity was archived in 2017, with an archive date of August 11, 2017.
What were the key close dates mentioned for this FOA?
The information provided lists an original closing date of September 7, 2017, a current closing date of July 12, 2017, and an archive date of August 11, 2017.
Where could applicants find the full announcement?
The full announcement was available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-253.html
Who was listed for technical help accessing the announcement?
NIH Office of Extramural Research (OER) webmaster contacts were listed for technical access issues.
What kinds of studies are a good fit for this mechanism?
This mechanism is best suited for applicants proposing stroke clinical trials or biomarker/outcome-measure validation studies that align with StrokeNet priorities in prevention, acute treatment, or recovery; that benefit from consistent, multi-site execution; and where the applicant already has a credible plan to fund the study costs that are not covered by the StrokeNet infrastructure awards.
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