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PAR-27-011

Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

Official Grants.gov opportunity PAR-27-011 from National Institutes of Health. Requires full eligibility, amount, controlling deadline, award-type and duplication QA before publication.

FundingApplicant-level ceiling not stated in the retrieved federal synopsis; verify in full NOFO.
Deadline2028-11-02 (official deadline clock time and time zone must be checked in NOFO)
Last verifiedAtlas review
Required next actionReview the official full announcement, amendments and submission portal requirements before applying.

Broad Eligibility

State governments; Native American tribal governments (Federally recognized); Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Public housing authorities/Indian housing authorities; County governments; Native American tribal organizations (other than Federally recognized tribal governments); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public and State controlled institutions of higher education; Private institutions of higher education; For profit organizations other than small businesses; Small businesses; Special district governments; City or township governments

Official funding announcement — preliminary draft

Funder: National Institutes of Health

Opportunity number: PAR-27-011

Official listed status: posted

Closing information: 2028-11-02 (official deadline clock time and time zone must be checked in NOFO)

Award disclosure: Applicant-level ceiling not stated in the retrieved federal synopsis; verify in full NOFO.

Applicant categories in federal synopsis: State governments; Native American tribal governments (Federally recognized); Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Public housing authorities/Indian housing authorities; County governments; Native American tribal organizations (other than Federally recognized tribal governments); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public and State controlled institutions of higher education; Private institutions of higher education; For profit organizations other than small businesses; Small businesses; Special district governments; City or township governments

Federal synopsis

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.

Draft intake record. Eligibility, program terms, current amendments and applicant ceiling must be independently verified before publishing.

Official Grants.gov opportunity and NOFO

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Source verificationOfficial government source · www.grants.govAtlas last verified this record during its latest review. Always use the funder's current application materials, amendments and portal instructions as the controlling source.View source and application materials ↗