Feasibility Studies to Inform the Design of Future Clinical Trials

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.

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).

The major elements in evaluating proposals include assessments of: (1) the scientific merit innovation and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; (6) the relevance and importance to the announced program objectives and when applicable,and (7) the adequacy of assurances detailing the proposed means for safeguarding human or animal subjects. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed...