NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
ID: 357066Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357066

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-054.html
Timeline
    Description

    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), is offering a funding opportunity for investigator-initiated exploratory clinical trials under the UG3/UH3 mechanism. This initiative aims to support Phase 1 and Phase 2 clinical trials that align with NINDS's mission, focusing on innovative approaches to evaluate drugs, devices, and interventions for neurological disorders. The funding is structured as a cooperative agreement with a maximum support period of five years, where the UG3 phase lasts up to two years, followed by a potential transition to the UH3 phase for executing clinical trials. Interested applicants should note that the application process opens on January 10, 2025, with a submission deadline of March 11, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-054.html
    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), has issued a Notice of Funding Opportunity (NOFO) for investigator-initiated exploratory Phase 1 and Phase 2 clinical trials (UG3/UH3 mechanism). This funding initiative is aimed at studies that align with NINDS’s mission, which includes drug and device evaluation, surgical, behavioral, and rehabilitation interventions for neurological disorders. The application process opens on January 10, 2025, with an application deadline of March 11, 2025. Proposals should focus on innovative trial designs that generate preliminary safety and efficacy data, enabling transition to Phase 2 trials. Key requirements include adherence to scientific rigor and transparency, demonstration of appropriate qualifications, and robust project feasibility. The funding mechanism provides a cooperative agreement with a maximum support period of five years, where the UG3 phase spans up to two years, followed by potential transition to the UH3 phase, aimed at executing the clinical trials. This NOFO emphasizes the importance of patient engagement, diverse participant recruitment, and comprehensive study planning to inform effective treatment pathways for neurological conditions while addressing regulatory and ethical considerations prominently.
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