Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
Forecasted Federal grant Posted
- Opportunity number
- PAR-27-125
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications expected due
- Award size
- Not on record
Opportunity facts
- Expected posting
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Non-501(c)(3) Nonprofits
- For Profit Organizations
- Higher Education Inst. (Public)
- Independent School Districts
- Other
- Public or Indian Housing Auth.
- State Governments
- Small Businesses
- Special District Governments
- Tribal Governments (Federally Recognized)
- County Governments
- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- 501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is forecasting a Notice of Funding Opportunity to solicit applications for investigator-initiated multi-site clinical trials, with a posting anticipated but no firm application deadline specified yet. This is a cooperative agreement mechanism structured as a bi-phasic UG3/UH3 award: a start-up phase of up to 2 years (UG3) followed by a full enrollment and implementation phase of up to 5 years (UH3), for a total award duration of up to 7 years. UG3 projects meeting their milestones will be administratively considered for transition to UH3 funding.
Eligible applicants include non-501(c)(3) nonprofits, for-profit organizations, higher education institutions (public and private), independent school districts, state and local governments, tribal governments and organizations, small businesses, special district governments, public or Indian housing authorities, faith-based and community-based organizations, regional organizations, Indian tribes not federally recognized, eligible federal agencies, U.S. territories or possessions, and non-domestic entities.
Proposed trials must meet the NIH definition of a clinical trial and align with the research missions of participating NIH Institutes and Centers. Applications may propose efficacy, effectiveness, pragmatic, and implementation research trials; large or complex single-site trials; or decentralized or virtual trials without physical clinical sites. Applicants must present the scientific rationale and a comprehensive scientific and operational plan for the trial, plus a detailed plan for overall project coordination, administration, data management, and biostatistical support.
Applications undergo peer review by an appropriate study section followed by secondary review by relevant NIH advisory councils. Evaluation criteria include scientific merit and significance, technical adequacy of experimental design, investigator competency, adequacy of facilities and resources, budget necessity, and relevance to program objectives. The source notes this is a forecast notification to allow potential applicants sufficient time to develop meaningful collaborations; applications are not yet being solicited. Program relevance encompasses cardiovascular diseases, lung diseases, blood disorders, sleep disorders, and related conditions under CFDA numbers 93.837, 93.838, 93.839, 93.840, and 93.233.
Forecast synopsis
The NIH intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to develop and implement investigator-initiated multi-site clinical trials, including efficacy, effectiveness, pragmatic, and/or implementation research clinical trials. Applications that propose a large and/or complex clinical trial conducted at either a single site or at multiple locations but without physical clinical sites (e.g., decentralized or virtual trials) may also be eligible. Proposed trials must be relevant to the research mission of the participating ICs and meet the NIH definition of a clinical trial (see NOT-OD-15-015 and NOT-OD-26-032). The objective of the application is to present 1) the scientific rationale as well as a comprehensive scientific and operational plan for the trial, and 2) a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial.
Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase up to 2 years (UG3) and a full enrollment and clinical trial implementation phase up to 5 years (UH3), for a total award duration of up to 7 years. A UG3 project that meets its milestones will be administratively considered for transition to the UH3 award. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO.
Eligibility
Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).
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