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Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)

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Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The National Institutes of Health plans to issue a Notice of Funding Opportunity to support investigator-initiated, multi-site clinical trials focused on efficacy, effectiveness, pragmatic, or implementation research, including decentralized or virtual trials without physical clinical sites. Proposals must align with the research missions of participating NIH Institutes and Centers and meet the NIH’s formal definition of a clinical trial. Applicants are expected to submit detailed scientific rationales and comprehensive plans covering both the trial design and operation, as well as robust infrastructure for project coordination, data management, and biostatistical support. While applications are not currently being accepted, this forecast provides advance notice to enable potential applicants to build collaborations and refine proposed studies. The funding mechanism will be a two-phase UG3/UH3 cooperative agreement, beginning with a UG3 award of up to two years for study design, planning, and milestone achievement, followed by a UH3 phase of up to five years for full trial implementation and enrollment. Transition from UG3 to UH3 is contingent upon successful completion of predefined milestones and will be subject to administrative review. The total potential award duration is seven years. The opportunity is open to researchers with relevant expertise and is managed by the Department of Health and Human Services through the NIH, with inquiries directed to the National Heart, Lung, and Blood Institute. The official announcement is forecasted to be posted on July 1, 2026.

General Info

NIH to fund multi-site clinical trials via UG3/UH3 cooperative agreement with milestone-based transition, open July 2026.

Agency

Department Of Health And Human Services → National Institutes Of HealthView Agency

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
View Agency Profile
Office AddressUS
Contacts
National Heart Lung and Blood Institute (NHLBI
contact@example.gov

Full Description

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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. 

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