Opportunity Information: Apply for PAR 20 285
The NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention funding opportunity (PAR-20-285) is a National Institutes of Health cooperative agreement designed to move high-priority stroke research forward by taking advantage of the established NIH StrokeNet clinical trials infrastructure. The overall intent is to support well-justified, multi-site studies that can meaningfully improve stroke prevention, acute treatment, and recovery, while also strengthening the tools researchers use to measure stroke outcomes. Rather than building a new trial network from scratch, the program is set up so that selected projects are carried out inside StrokeNet, which is meant to speed up start-up, improve recruitment, standardize operations, and increase the odds that studies are completed on time and with strong data quality.
The opportunity encourages several types of projects. One major category is multi-site exploratory and confirmatory clinical trials that test promising interventions relevant to stroke prevention, treatment, or rehabilitation/recovery. Another category focuses on biomarker or outcome measure validation studies, particularly those that are immediately preparatory to clinical trials. In practice, that means the research should be positioned to directly inform or enable next-step clinical testing, for example by validating an imaging marker, blood-based biomarker, physiologic measure, or functional outcome assessment that can be used to select patients, stratify risk, monitor response, or serve as an endpoint. A third category includes ancillary studies that add additional scientific aims onto ongoing StrokeNet studies, allowing investigators to leverage active trials and established cohorts to answer complementary questions efficiently.
A defining feature of this program is that it uses a cooperative agreement mechanism (UG3/UH3), which signals substantial NIH involvement beyond typical grant oversight. Under this structure, applicants are not only proposing a study but also agreeing to work closely with StrokeNet leadership and NIH partners to refine and execute it. After peer review, the National Institute of Neurological Disorders and Stroke (NINDS) will select and prioritize studies from among the highest-scoring applications for implementation within the StrokeNet platform. This prioritization step matters because it means strong scientific scores alone may not guarantee selection; program priorities, feasibility within the network, and overall portfolio balance can influence which projects ultimately move forward.
If a project is selected, the StrokeNet infrastructure provides specific operational support. The NIH StrokeNet National Coordinating Center (NCC) works with the awardee to implement the study efficiently, which typically includes coordinating trial start-up activities, harmonizing site operations, and supporting consistent protocol execution across locations. The National Data Management Center (NDMC) provides statistical and data management support, which generally covers core functions like database development, data quality control, and statistical planning and analysis. Recruitment, retention, and on-the-ground protocol delivery are supported through the StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which is particularly important for multi-site enrollment, standardized intervention delivery, and follow-up assessments.
Eligibility is broad across U.S.-based organizations and spans many sectors that can contribute to clinical research, including state, county, city, and special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The announcement also explicitly highlights additional eligible applicants 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply, though foreign components as defined by the NIH Grants Policy Statement are allowed, which can permit certain international elements when justified and compliant with NIH policy.
Administratively, this is an NIH discretionary funding opportunity in the health category (CFDA 93.853) using the cooperative agreement funding instrument. The funding opportunity was created on 2020-07-29, with an original closing date listed as 2023-11-17. The public summary does not specify an award ceiling or expected number of awards in the excerpt provided, which typically means applicants need to consult the full FOA and associated NIH guidance for budget parameters, phase structure (UG3 planning/start-up versus UH3 implementation), milestones, and any network-specific requirements for protocol readiness and feasibility.
In plain terms, this opportunity is aimed at investigators who have a stroke-focused clinical study that is ready to be executed at multiple sites and would benefit from a mature national trial network, centralized coordination, and integrated data management. The emphasis is on projects that are both scientifically compelling and operationally feasible within StrokeNet, including trials of interventions, studies that validate biomarkers or outcome measures needed for better trials, and add-on ancillary aims that can be efficiently layered onto ongoing StrokeNet research.Apply for PAR 20 285
- 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 (UG3/UH3 Clinical Trial Optional)" 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 2020-07-29.
- Applicants must submit their applications by 2023-11-17. (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 (PAR-20-285)
What is PAR-20-285 in simple terms?
PAR-20-285 is an NIH funding opportunity that supports stroke-related clinical research carried out within the NIH StrokeNet infrastructure. The goal is to move high-priority stroke studies forward more efficiently by using an established national clinical trials network rather than building new multi-site operations from scratch.
What is the main purpose of this opportunity?
The intent is to support well-justified, multi-site studies that can meaningfully improve stroke prevention, acute treatment, and recovery. It also aims to strengthen the tools used to measure stroke outcomes by supporting validation of biomarkers and outcome measures that are immediately preparatory to clinical trials.
What types of projects are encouraged under this program?
The opportunity encourages (1) multi-site exploratory and confirmatory clinical trials for stroke prevention, treatment, or rehabilitation/recovery; (2) biomarker or outcome measure validation studies that are immediately preparatory to clinical trials; and (3) ancillary studies that add scientific aims onto ongoing StrokeNet studies.
Does this funding opportunity focus only on treatment trials?
No. While clinical trials of interventions are a major focus, the program also supports studies that validate biomarkers or outcome measures (such as imaging markers, blood-based biomarkers, physiologic measures, or functional outcome assessments) and ancillary studies that leverage ongoing StrokeNet trials or cohorts.
What is meant by multi-site clinical trials in this context?
Multi-site trials are studies conducted across multiple clinical locations to improve recruitment, increase generalizability, and support standardized operations. Under this opportunity, the studies are intended to run within the NIH StrokeNet platform, which is designed to help with start-up, recruitment, and consistency across sites.
What kinds of interventions might be tested?
The excerpt describes interventions relevant to stroke prevention, acute treatment, and rehabilitation/recovery, but it does not list specific intervention types. The emphasis is on promising interventions suitable for multi-site exploratory or confirmatory testing within StrokeNet.
What is a biomarker or outcome measure validation study here?
These studies focus on validating measures that can directly enable or inform clinical trials. Examples mentioned include imaging markers, blood-based biomarkers, physiologic measures, and functional outcome assessments. The validated measure could help select patients, stratify risk, monitor response, or serve as a trial endpoint.
What does "immediately preparatory to clinical trials" mean?
It means the biomarker or outcome measure work should be positioned to directly support next-step clinical testing. In practice, the validation should be close enough to real-world trial use that it can meaningfully improve trial design, execution, or interpretation.
What are ancillary studies in the StrokeNet context?
Ancillary studies are add-on projects that layer additional scientific aims onto ongoing StrokeNet studies. This allows investigators to leverage active trials and established cohorts to answer complementary questions efficiently.
What makes this a cooperative agreement rather than a typical grant?
This opportunity uses a cooperative agreement mechanism (UG3/UH3), which indicates substantial NIH involvement beyond typical grant oversight. Applicants are expected to work closely with NIH partners and StrokeNet leadership to refine and execute the study once selected.
What is the UG3/UH3 mechanism?
The excerpt identifies the mechanism as UG3/UH3 but does not provide detailed phase requirements. It indicates that applicants should consult the full FOA and NIH guidance for details on phase structure (UG3 planning/start-up versus UH3 implementation), milestones, and network-specific requirements.
Is peer review scoring the only factor in whether a project is implemented?
No. After peer review, NINDS selects and prioritizes studies for implementation within StrokeNet from among the highest-scoring applications. The excerpt notes that strong scientific scores alone may not guarantee selection because program priorities, feasibility within StrokeNet, and portfolio balance may influence final decisions.
Who makes the final selection for implementation within StrokeNet?
The National Institute of Neurological Disorders and Stroke (NINDS) selects and prioritizes studies from among the highest-scoring applications after peer review for implementation within the NIH StrokeNet platform.
What is NIH StrokeNet and why does it matter for applicants?
NIH StrokeNet is an established clinical trials infrastructure intended to speed study start-up, improve recruitment, standardize operations, and increase the likelihood that studies finish on time with strong data quality. Projects funded under this opportunity are meant to be carried out inside StrokeNet.
What operational support does StrokeNet provide if a project is selected?
StrokeNet provides centralized operational and data support through several components: the National Coordinating Center (NCC), the National Data Management Center (NDMC), and the Regional Coordinating Centers (RCCs) and their affiliated clinical sites.
What does the NIH StrokeNet National Coordinating Center (NCC) do for a funded study?
The NCC works with the awardee to implement the study efficiently. The excerpt describes support such as coordinating trial start-up activities, harmonizing site operations, and supporting consistent protocol execution across locations.
What does the National Data Management Center (NDMC) do?
The NDMC provides statistical and data management support. The excerpt describes core functions like database development, data quality control, and statistical planning and analysis.
How are recruitment and on-the-ground trial activities supported?
Recruitment, retention, and protocol delivery are supported through StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites. This support is especially important for multi-site enrollment, standardized delivery of interventions, and follow-up assessments.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and includes many entity types: state, county, city, and special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities.
Are specific institution types explicitly highlighted as eligible?
Yes. The opportunity explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Can non-U.S. organizations apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization include non-U.S. components?
Non-domestic components of U.S. organizations are not eligible to apply. However, foreign components (as defined by the NIH Grants Policy Statement) are allowed, which may permit certain international elements when justified and compliant with NIH policy.
What is the funding instrument and agency behind this opportunity?
This is an NIH discretionary funding opportunity in the health category using a cooperative agreement funding instrument (UG3/UH3). The institute role referenced in selection is NINDS, and the infrastructure used is NIH StrokeNet.
What CFDA number is associated with this opportunity?
The excerpt lists CFDA 93.853.
When was this opportunity created and what closing date is listed?
The excerpt states the opportunity was created on 2020-07-29 and lists an original closing date of 2023-11-17.
Does the excerpt specify an award ceiling or the expected number of awards?
No. The public summary excerpt provided does not specify an award ceiling or expected number of awards. It notes that applicants typically need to consult the full FOA and associated NIH guidance for budget parameters and other details.
Where should applicants look for details like budgets, milestones, and UG3 versus UH3 requirements?
The excerpt indicates that applicants should consult the full FOA and related NIH guidance for budget parameters, phase structure (UG3 planning/start-up versus UH3 implementation), milestones, and any network-specific requirements for protocol readiness and feasibility.
What kinds of studies are a good fit for this program?
The excerpt describes a good fit as a stroke-focused clinical study ready to be executed across multiple sites and likely to benefit from a mature national trial network, centralized coordination, and integrated data management. It also emphasizes that projects should be scientifically compelling and operationally feasible within StrokeNet.
Why does running a study inside StrokeNet potentially improve timelines and data quality?
According to the excerpt, the StrokeNet platform is intended to speed up start-up, improve recruitment, standardize operations, and increase the odds that studies are completed on time with strong data quality through centralized coordination and data management support.
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