Feasibility Studies to Inform the Design of Future Clinical Trials
Forecasted Federal grant Posted
- Opportunity number
- PAR-28-011
- 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
- Grant
- Category
-
- Health
- Eligible applicants
-
- Non-501(c)(3) Nonprofits
- Independent School Districts
- State Governments
- 501(c)(3) Nonprofits
- Tribal Governments (Federally Recognized)
- City/Township Governments
- Public or Indian Housing Auth.
- Other
- County Governments
- For Profit Organizations
- Special District Governments
- Small Businesses
- Higher Education Inst. (Public)
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Private)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health intends to publish a Notice of Funding Opportunity to solicit applications for feasibility studies designed to inform the planning and conduct of subsequent definitive clinical trials, though applications are not being accepted at this time and no hard deadline is set. This is a forecast notice providing potential applicants time to develop collaborations and responsive projects before the formal NOFO opens.
Eligible applicants include 501(c)(3) and non-501(c)(3) nonprofits, higher education institutions (public and private), state and local governments, tribal governments and organizations, small businesses, for-profit organizations, and other specialized entities including faith-based and community-based organizations, U.S. territories, and non-domestic entities. Federally recognized and non-federally recognized Indian tribes may apply, as may eligible federal agencies and regional organizations.
Applicants must propose feasibility research demonstrating scientific necessity for informing the design or plan of a subsequent definitive clinical trial. Acceptable study designs include mixed-methods and feasibility clinical trials assessing recruitment, randomization, retention, intervention delivery, data collection, adherence, acceptability, or development and adaptation of intervention components and protocols. The proposed feasibility research must enhance rigor and reproducibility of future trial methods, and the subsequent definitive trial must have potential for significant public health impact.
The opportunity falls under Assistance Listing 93.213 (Research and Training in Complementary and Integrative Health), administered by the National Center for Complementary and Integrative Health. Standard NIH evaluation criteria apply: scientific merit, innovation, significance, technical adequacy of design, investigator competency, resource adequacy, budget necessity, program relevance, and human or animal subject protections where applicable. Award timelines typically run 6 to 10 months from application to notice of award. No cost share is specified in the forecast notice.
Forecast synopsis
The National Institutes of Health intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose feasibility studies that could inform the design and conduct of subsequent definitive clinical trials (e.g., efficacy, effectiveness, pragmatic, dissemination and implementation, phase/stage II or later trials). Applications to this NOFO should demonstrate that the proposed feasibility research is scientifically necessary to design or plan the subsequent definitive clinical trial. Studies may utilize mixed methods and feasibility clinical trials to assess feasibility of recruitment, randomization, retention, intervention delivery, data collection, adherence, acceptability, and/or develop or adapt intervention components or protocols. The proposed feasibility research should enhance the rigor and reproducibility of the future trial methods. The subsequent definitive clinical trial should have the potential to make a significant impact on public health.
Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to begin to consider applying for this new 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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