NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
ID: 353319Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $2M

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)" aimed at supporting investigator-initiated Phase I clinical trials for heart, lung, blood, and sleep (HLBS) disorders. Applicants are expected to initiate their clinical trials within the first quarter of the project period, with a focus on developing therapeutic and diagnostic interventions, and must provide a detailed project management plan that includes milestones for trial completion and participant enrollment. This grant, identified as PAR-24-172, allows for direct costs up to $1.515 million per year and may extend for a duration of up to three years, promoting inclusivity in clinical research by encouraging participation from underrepresented groups. Interested applicants can find more information and submit inquiries via email to grantsinfo@nih.gov, with the application deadline set for January 7, 2027.

    Point(s) of Contact
    Files
    Title
    Posted
    Please provide the text that you would like to have summarized.
    The National Heart, Lung, and Blood Institute (NHLBI) is issuing a Notice of Funding Opportunity (NOFO) for R33 exploratory grants aimed at supporting Phase I clinical trials for therapeutic and diagnostic interventions related to heart, lung, blood, and sleep disorders for both adults and children. Applications are sought from eligible organizations, with key dates for submission starting May 4, 2024, and the maximum award term spanning up to three years with an annual budget cap of $1,515,000 in direct costs. The funding is guided by milestones emphasizing safety assessments and goals for timely completion of clinical trials, and applications not aligned with specified objectives will be considered non-responsive.
    Similar Opportunities
    NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity (FON: PAR-24-173) aimed at supporting Phase I clinical trials for therapeutics and diagnostics related to heart, lung, blood, and sleep (HLBS) disorders in both adults and children. This initiative utilizes a bi-phasic R61/R33 award mechanism, where the R61 phase focuses on preparatory activities such as finalizing trial protocols and gathering preclinical data, while the R33 phase is dedicated to executing the clinical trial. The funding limits include up to $250,000 annually for the R61 phase and $1,515,000 for the R33 phase, with total support available for a maximum of five years. Interested applicants must adhere to NIH guidelines and submit their proposals by January 7, 2027, to be considered for this opportunity. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for R34 Clinical Trial Pilot Studies aimed at supporting research that informs the planning of Phase II-IV clinical trials focused on heart, lung, blood, and sleep disorders. Applicants are required to demonstrate that their proposed studies are essential for the design of future trials and must include a Plan for Enhancing Diverse Perspectives (PEDP) to promote diversity within research teams. This initiative is critical for advancing clinical practice and understanding in these vital health areas, with awards of up to $450,000 available over three years. Interested applicants should submit their proposals by January 7, 2027, and can find additional information at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity for Single-Site Investigator-Initiated Clinical Trials (R61/R33), aimed at supporting applications for clinical trials that test therapeutic, behavioral, or prevention strategies relevant to NHLBI's mission. This funding mechanism involves a bi-phasic award structure, with an initial R61 phase focused on protocol development followed by an R33 phase for trial execution, emphasizing comprehensive project management, subject recruitment, and community engagement. The initiative is particularly significant for advancing clinical research while promoting diversity among study participants and project teams. Interested applicants can find more details and submit proposals by September 12, 2025, and should direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the "Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research" grant, aimed at advancing technologies that address heart, lung, blood, and sleep (HLBS) disorders. This funding opportunity specifically seeks R33 exploratory/developmental grant applications that focus on mid-stage developments requiring further validation and refinement, with an emphasis on demonstrating novelty and substantial improvement over existing methods. The initiative is crucial for facilitating transformations in HLBS-related research and clinical practices, promoting the swift adoption of breakthrough technologies. Interested applicants can apply for funding of up to $1.86 million annually, with a submission deadline of December 20, 2024. For further inquiries, applicants may contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NHLBI Program Project Applications (P01 Clinical Trials Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity for Program Project (P01) grant applications aimed at advancing research in heart, lung, and blood diseases. Applicants are required to submit proposals that include a minimum of three interrelated research projects focused on a common biomedical theme, with the option to incorporate clinical trials. This initiative is designed to foster collaborative research efforts and encourage innovative scientific directions, particularly supporting projects led by Early Stage Investigators (ESIs). The maximum funding for awarded projects is capped at $1.515 million annually, or $1.765 million if an ESI-led project is included, with a project duration of up to five years. Interested applicants can find more information and submit their proposals electronically via Grants.gov, with a closing date for applications set for September 25, 2026. For further inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity for exploratory R21 grant applications focused on secondary analyses of existing human datasets related to heart, lung, blood diseases, and sleep disorders. The objective of this grant is to stimulate innovative research by utilizing existing datasets to explore novel scientific ideas and develop impactful biomedical tools and technologies, without the need for new primary data collection. This initiative is crucial for advancing public health research aligned with NHLBI priorities, with an annual funding commitment of up to $2,187,000 over three years, supporting approximately eighteen new awards each year, with a maximum of $75,000 in direct costs per application for a two-year project period. Interested applicants can find more information and application guidelines at NIH Grants, and should note that the application deadline is January 7, 2026.
    NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced a funding opportunity titled "NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders" (X01), aimed at leveraging the TOPMed program to explore the molecular mechanisms underlying heart, lung, blood, and sleep disorders. This initiative invites applications to generate integrated genetic and multi-omics data to address knowledge gaps not covered by existing datasets, with a focus on promoting personalized medicine and encouraging data-sharing practices. While no direct funding will be provided under this opportunity, applicants are encouraged to propose innovative multi-omics studies that utilize high-quality biospecimens from well-characterized cohorts. The application deadline is October 17, 2024, and interested parties can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries. More details can be found at the provided link: http://grants.nih.gov/grants/guide/pa-files/PAR-22-194.html.
    Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed) grant. This funding opportunity aims to support projects that address critical needs for clinical trial readiness in rare diseases, specifically by facilitating the development of biomarkers and clinical outcome measures essential for trial design. The initiative is particularly important for advancing research on diseases affecting fewer than 200,000 individuals in the U.S., enhancing the likelihood of successful clinical trials. Applicants can request up to $275,000 over two years, with a submission deadline of October 17, 2024. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-23-159.html.
    Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the development of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials under the UG3/UH3 activity codes. This initiative aims to foster innovative trial designs relevant to the National Heart, Lung, and Blood Institute's (NHLBI) research mission, requiring comprehensive project plans that address participant recruitment, milestone achievements, and strategies for enhancing community engagement and diversity. The funding mechanism is bi-phasic and necessitates simultaneous applications for both a CCC and a collaborating Data Coordinating Center (DCC), emphasizing strong project management and a commitment to minimizing health disparities. Interested applicants must submit their proposals by September 11, 2025, and can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries. More details can be found in the full announcement at http://grants.nih.gov/grants/guide/pa-files/PAR-22-192.html.
    Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Catalyze: Product Definition for Small Molecules and Biologics - Preliminary Product/Lead Series Identification (R33 - Clinical Trial Not Allowed)" aimed at supporting early-stage translational research for developing therapeutic agents targeting heart, lung, blood, and sleep disorders. This initiative seeks to identify lead compound series and bridge the gap between basic science discoveries and preclinical testing, emphasizing innovation through novel therapeutic approaches and strong biological rationale. The grant offers a maximum funding amount of $350,000 over a two-year period, with no cost-sharing requirement, and applications are due by December 20, 2024. For further inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-23-012.html.