Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)
ID: RFA-TR-24-001Type: Phase II
Overview

Topic

Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: Phase IIYear: 2024

Topic Link

https://www.sbir.gov/node/2486945

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-24-001.html
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for a Small Business Innovation Research (SBIR) program focused on "Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases." The goal of this program is to support clinical trials of drugs that target shared molecular causes of at least two different rare diseases. The program aims to overcome the limitation of traditional clinical trials that focus on one disease at a time, resulting in the exclusion of patients with less common diseases. The funding opportunity will utilize a Small Business Innovation Research (SBIR) U44 cooperative agreement to support Investigational New Drug (IND) enabling studies and a subsequent small clinical trial involving at least two different rare diseases. The program encourages collaboration with academic institutions and clinical investigators who are part of the Rare Disease Clinical Research Network (RDCRN). The duration of the program will depend on the maturity of the project, and successful projects will transition from Phase I to Phase II based on defined milestones, including the submission of an IND to the FDA. Applicants are advised to consult with NIH Scientific/Research staff before submitting their proposals.

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