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

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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 is forecasting a funding opportunity for investigator-initiated multi-site clinical trials, including efficacy, effectiveness, pragmatic, and implementation research. Eligible projects may include large or complex trials conducted at a single site, multiple locations, or through decentralized and virtual models. Applicants must provide a detailed scientific rationale, an operational plan for the trial, and a comprehensive strategy for project coordination, data management, and biostatistical support. This opportunity utilizes a bi-phasic, milestone-driven UG3/UH3 mechanism. The award structure consists of an initial start-up phase of up to two years, followed by a full enrollment and implementation phase of up to five years, for a total potential duration of seven years. Transition from the UG3 to the UH3 phase is contingent upon meeting specified milestones. While applications are not currently being accepted, this notice serves to allow potential investigators to establish collaborations and develop responsive projects.

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 Health

NAICS

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

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
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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