NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)

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Key Information

Due Date: March 10, 2025


Agency: U.S. Department of Health and Human Services (HHS)


Source: Federal


Funding Category:

Health & Human Services

Funding Amount: $581,371


Funding Type: Cooperative Agreement, Government


Match Required: No


Contact Info: OERWebmaster03@od.nih.gov
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

Overview

The National Institute for Neurological Disorders and Stroke (NINDS) is encouraging applications for their Exploratory Clinical Trials grant, requiring a UG3/UH3 Clinical Trial. This grant is aimed at supporting investigator-initiated exploratory clinical trials. The trials should align with the objectives and interests of NINDS, including studies such as Phase 1 and 2 trials involving drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral, or rehabilitation therapies.

The purpose of these exploratory trials is to contribute to the data needed for justifying future trials focused on establishing efficacy, such as Phase 3, Phase 4, or Pivotal trials. The UG3/UH3 mechanism is employed in this grant. Satisfactory progress in the UG3 phase is necessary to progress to the UH3 phase.

Specifically, for a drug, biologic, or device that hasn't completed a Phase 1/Early Feasibility trial, the UG3 phase will be used to plan and carry out the Phase 1 trial(s). If Phase 1 trials are successful, the UG3 phase will also include planning for a Phase 2 trial. The execution of the Phase 2 clinical trial will then be supported by the UH3 mechanism, contingent upon the successful achievement of agreed milestones.

If a drug, biologic, or device has successfully completed the Phase 1/Early Feasibility trial(s), this grant is not applicable. Instead, a Companion Funding Opportunity Announcement (FOA XXX) should be used. Similarly, this grant does not apply to genetic studies; FOA XXX should be utilized for such trials.

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Key Dates

Open Date: April 18, 2022


Application Due Date: March 10, 2025


Estimated Award Date: Not Specified

Additional Details

Eligible Activities

  • Research and Development

Eligible Applicants

  • State governments
  • County governments
  • City, village or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Private institutions of higher education
  • Small businesses

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