NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Open Posted
- Opportunity number
- PAR-25-032
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- State Governments
- Other
- County Governments
- Higher Education Inst. (Private)
- Higher Education Inst. (Public)
- Small Businesses
- Independent School Districts
- Tribal Governments (Federally Recognized)
- Public or Indian Housing Auth.
- Non-501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- For Profit Organizations
- City/Township Governments
- Special District Governments
- 501(c)(3) Nonprofits
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health National Heart, Lung, and Blood Institute is soliciting applications for the NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) mechanism, with applications due March 16, 2027. The R34 supports pilot studies designed to inform the planning and development of Phase II, III, or IV clinical trials testing efficacy, safety, clinical management, or implementation of interventions in prevention and treatment of heart, lung, blood, and sleep disorders; any subsequent Phase II-IV trial will require a separate application.
Eligible applicants include state and local governments, tribal governments (federally and non-federally recognized), higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, special district governments, public and Indian housing authorities, and independent school districts. Eligible applicants also include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, regional organizations, U.S. territories and possessions, and eligible federal agencies. Non-domestic (non-U.S.) entities are not eligible to apply; however, non-domestic components of U.S. organizations and foreign components as defined in the NIH Grants Policy Statement are allowed.
The R34 mechanism is structured to generate new scientific or operational information answering specific research questions that inform final development of the planned future trial, distinguishing it from standard trial start-up or preparation funding. Applications must demonstrate that the proposed R34 research is scientifically necessary to design or plan the subsequent trial and will produce results sufficient to inform the future trial without requiring additional studies.
The opportunity is assigned to five CFDA programs: Lung Diseases Research (93.838), Cardiovascular Diseases Research (93.837), Translation and Implementation Science Research (93.840), Blood Diseases and Resources Research (93.839), and National Center on Sleep Disorders Research (93.233). All applications are reviewed by an appropriate initial review group study section and receive final secondary review by the National Heart, Lung, and Blood Advisory Council, with evaluation based on scientific merit, technical adequacy, investigator competency, facility adequacy, budget necessity, and relevance to program objectives.
Synopsis
2 versions
Update #2 · Latest ·
This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.
Update #1 ·
This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.
Eligibility
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 Organizations) are not 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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-032-Full-Announcement.html | HTML file | |
| PKG00289726.pdf |
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