NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
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.
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.
Related Programs
Department of Health and Human Services
National Center on Sleep Disorders Research
Department of Health and Human ServicesCardiovascular Diseases Research
Department of Health and Human ServicesDepartment of Health and Human Services
Blood Diseases and Resources Research
Department of Health and Human Services
Agency: Department of Health and Human Services
Office: National Institutes of Health
Estimated Funding: $88,700,000
Office: National Institutes of Health
Estimated Funding: $88,700,000
Who's Eligible
Relevant Nonprofit Program Categories
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/pa-files/PAR-25-032.html
Additional Information of 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.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/pa-files/PAR-25-032.html
Contact:
Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Agency Email:
Date Posted:
2024-12-18
Application Due Date:
Archive Date:
2027-02-12
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