At a glance
This program funds pilot studies that fill information gaps needed to complete the protocol for a future Phase II to IV clinical trial for heart, lung, blood, or sleep disorders. It can support work such as refining the study population, intervention, outcomes, statistical methods, adherence, training tools, or feasibility, but it does not support first-in-human studies, animal studies, purely mechanistic studies, protocol writing, infrastructure development, or malignancy-related research. Eligible applicants include many U.S. organizations such as nonprofits, universities, governments, tribal entities, small businesses, and faith-based or community-based organizations; foreign organizations are not eligible, though foreign components of U.S. organizations are allowed. Applications may request up to $450,000 in direct costs over 3 years, with no more than $225,000 in direct costs in any single year, and no cost sharing is required.
What it funds
Official description from grants.gov
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.
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments