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 (R33 CT Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the NHLBI Early Phase Clinical Trials (R33), aimed at supporting investigator-initiated Phase I clinical trials for therapeutic and diagnostic interventions targeting heart, lung, blood, and sleep (HLBS) disorders. Applicants are required to be prepared to initiate their clinical trials within the first quarter of the project period and must demonstrate readiness in obtaining necessary regulatory approvals, including FDA and IRB, prior to the award. This funding is crucial for addressing unmet medical needs through innovative research, with a maximum budget of $1.515 million per year and a project duration of up to three years, contingent upon achieving specific milestones. Interested applicants should note the application deadline of June 4, 2024, and can direct inquiries to NIH Grants Information at grantsinfo@nih.gov for further details.
    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) is offering a funding opportunity titled "NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders," aimed at supporting investigator-initiated Phase I clinical trials for heart, lung, blood, and sleep (HLBS) disorders in both adults and children. This grant (R61/R33) facilitates funding for essential preclinical activities and the execution of clinical trials, structured in two phases: the R61 phase focuses on preparatory tasks, while the R33 phase involves the actual trial conduct, guided by specific milestones. This initiative is crucial for advancing research that addresses significant health challenges associated with HLBS disorders. Interested applicants can submit proposals starting January 3, 2025, with a maximum project period of five years, and should direct inquiries to grantsinfo@nih.gov. For more details, visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-026.html.
    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 Clinical Trial Pilot Studies (R34 Clinical Trial Optional) through the National Heart, Lung, and Blood Institute (NHLBI). This initiative aims to support research that provides essential information for the design of future Phase II-IV clinical trials focused on heart, lung, blood, and sleep disorders, requiring applicants to demonstrate the scientific necessity and sufficiency of their proposed studies. The NHLBI emphasizes inclusivity by mandating a Plan for Enhancing Diverse Perspectives (PEDP) to enhance the project's scientific merit, with a budget of up to $450,000 in direct costs available over a maximum project period of three years. Interested applicants should note that the application period opens on January 16, 2025, and the final submission deadline is January 7, 2027; for further inquiries, they 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.
    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), through the National Heart, Lung, and Blood Institute (NHLBI), is offering a funding opportunity titled "Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)." This grant aims to support the development and validation of innovative technologies that address significant gaps in heart, lung, blood, and sleep (HLBS) research, focusing on advancing diagnostic and therapeutic solutions with promising preliminary data. Eligible applicants include a wide range of institutions and organizations, with a budget ceiling of $350,000 in direct costs per year, and total funding commitments expected to reach $2,156,000 annually for the next three fiscal years. The application deadline is set for January 11, 2025, and further details can be found on the NIH grants website or by contacting NIH Grants Information at grantsinfo@nih.gov.
    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.
    Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)" grant, aimed at supporting the development and execution of single-site clinical trials focused on efficacy, comparative effectiveness, and implementation research. Applicants are required to present a comprehensive scientific and operational plan, including project management strategies, subject recruitment and retention plans, and community engagement efforts, all aligned with the mission of the National Heart, Lung, and Blood Institute (NHLBI). This funding opportunity emphasizes the importance of diverse perspectives and strong project management in advancing health research through innovative trial designs. Interested applicants should note that the application deadline is September 11, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    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.