HEAL INITIATIVE: Development and validation of remote or patient wearable device derived objective biosignatures or functional assessments to monitor pain for use as endpoints in clinical trials (UG3/UH3 - Clinical Trial Optional)
ID: 350068Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Income Security and Social Services

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity under the HEAL Initiative to develop and validate remote or wearable device-derived biosignatures for monitoring pain in clinical trials. This initiative aims to enhance pain assessment methodologies, ultimately improving treatment outcomes and quality of life for patients suffering from chronic pain. The funding will support multidisciplinary teams in creating digital biosignature algorithms and software, with a total of up to $5.1 million available for 4-6 awards in FY 2024. Interested applicants must submit their proposals by October 5, 2024, and can find additional information at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov.

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    Title
    Posted
    The National Institutes of Health (NIH) is issuing a Notice of Funding Opportunity (NOFO) under the HEAL Initiative, aimed at developing and validating digital endpoints derived from remote or wearable devices to monitor pain in clinical trials. The purpose is to enhance pain assessment methods to improve treatment outcomes and patient quality of life. Projects will utilize a phased award mechanism (UG3/UH3), with the UG3 phase focusing on proof of concept and testing, while the UH3 phase involves longitudinal clinical studies for validation. Key points include the necessity of multidisciplinary teams, incorporating patient perspectives, and ensuring diversity in study populations. Applications should demonstrate comprehensive research plans, including the establishment of digital biosignature algorithms and software for pain assessment. Up to $5.1 million is anticipated for funding 4-6 awards in FY 2024, with strict adherence to application guidelines and milestones required for progression through phases. The initiative emphasizes scientific rigor, transparency, and the importance of regulatory guidance from the FDA. This funding opportunity addresses significant issues related to chronic pain management and opioid reliance while fostering innovation in assessment technologies.
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