NIH Pragmatic Trials Conducted in Health Care Systems

The National Institutes of Health intends to publish a Notice of Funding Opportunity (NOFO), Pragmatic and Implementation Trials Conducted in Health Care Settings This funding opportunity will support large-scale pragmatic trials that test intervention effectiveness in routine clinical care and/or implementation trials that evaluate strategies for delivering interventions within health care settings. These trials are intended to directly inform decision-makers (e.g., patients, clinicians, administrators, policymakers, and payers) about the comparative benefits, burdens, and risks of biomedical or behavioral interventions. To enhance real-world relevance and generalizability, applicants are encouraged to: 1) Select care settings where the target condition is commonly seen (e.g., emergency departments, primary care, public health clinics). 2) Include multiple health system types (e.g., academic centers, federally qualified health centers, integrated networks, VA Medical Centers). 3) Assess adaptation across systems and regions to ensure intervention effectiveness and implementation feasibility. Interventions under study should be embedded in routine care. Trials may integrate one or more interventions with established efficacy into appropriate health care settings or implement system-level changes to improve health outcomes. This phased award will use a milestone-driven cooperative agreement mechanism, supporting a planning phase and a phase for full trial execution. 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. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this 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...

Research grants: Single project grant applications must be prepared electronically through grants.gov (http://www.grants.gov) using the SF 424 (Research and Research-Related) and PHS 398 instructions.Multi-project grant applications must be submitted through the A.S.S.I.S.T (Application Submission System & Interface for Submission Tracking) system. Individual funding opportunity announcements will indicate the appropriate application format to be used. A listing of NCCIH and other funding opportunities can be found through the NCCIH web site (http://www.nccih.nih.gov/grants/funding), through the Grants.gov web site (http://www.grants.gov/), or on the NIH Guide to Grants and Contracts (https://grants.nih.gov/funding/searchguide/index.html#/). For applications that require the PHS 398, the most recent version of the form and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Electronic applications are submitted through the Grants.gov website. Completed PHS 398 applications should be submitted to the National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710 or Bethesda, MD 20817 (for express/courier service). For assistance contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov. National Research Services Awards: Completed application forms should be submitted to the Office of Research Manpower, Center for Scientific Review,...