First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)
ID: 331814Type: 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/331814

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-21-133.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for early-stage clinical trials of novel investigational drugs and devices aimed at treating psychiatric disorders, under the title "First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 Clinical Trial Required)." This initiative encourages cooperative agreement applications to support first-in-human trials and Phase II studies that assess safety, pharmacological effects, and clinical relevance, with a focus on addressing unmet medical needs in both pediatric and adult populations. A total of $27 million is available for this initiative, which emphasizes collaboration between biomedical researchers and industry partners to facilitate the development of effective treatments. Interested applicants must submit their proposals by October 15, 2024, and can find additional information and submission guidelines at the NIH grants website or contact the NIH OER Webmaster at FBOWebmaster@OD.NIH.GOV for assistance.

    Point(s) of Contact
    FBOWebmaster@OD.NIH.GOV
    Files
    Title
    Posted
    PAR-21-133-Full-Announcement.html
    PAR-21-133.html
    The Department of Health and Human Services, specifically through the National Institutes of Health (NIH) and the National Institute of Mental Health (NIMH), issues a funding opportunity aimed at early-stage clinical trials of novel investigational drugs and devices for psychiatric disorders. This initiative, labeled as PAR-21-133, emphasizes collaboration between biomedical researchers and industry partners to accelerate the development of treatments addressing unmet medical needs. The FOA supports first-in-human trials, Phase Ib, and Phase II/proof of concept studies, including new neuromodulatory devices. Importantly, applicants must demonstrate rigorous methodologies that assess safety, pharmacodynamics, and clinical relevance, ensuring the proposed research aligns with current knowledge and addresses significant barriers in psychiatric treatment development. Applications must comply with detailed submission guidelines, including the timely provision of required documentation and adherence to ethical regulations. A total of $27 million is designated to fund this initiative across various applications, expecting rigorous milestone management for successful project progression. The scope is broad, encouraging diverse organizations such as higher education institutions, nonprofits, and for-profit organizations to apply, all aimed at fostering innovation within the psychiatric field.
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