Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)
ID: 352228Type: 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
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for a Data Coordinating Center (DCC) to support multi-site clinical trials focused on natural products, under the Notice of Funding Opportunity (NOFO) PAR-24-125. The DCC is expected to provide comprehensive project coordination, data management, and biostatistical support for clinical trials at Phase III and beyond, requiring applicants to submit a corresponding Clinical Coordinating Center (CCC) application simultaneously. This initiative emphasizes the importance of rigorous scientific research and inclusivity in clinical trial participation, mandating a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application process. Interested applicants must submit their proposals by July 19, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Center for Complementary and Integrative Health (NCCIH), has issued a funding opportunity for a Data Coordinating Center (DCC) to support multi-site clinical trials of natural products (PAR-24-125). This collaborative U24 grant aims to enhance project coordination, data management, and biostatistical support for Phase III and beyond trials. Applicants must also submit a corresponding Clinical Coordinating Center (CCC) application, both due by specified dates. The DCC's key role includes ensuring appropriate trial design, managing data collection and analysis, monitoring adverse events, and providing interim reports. A Plan for Enhancing Diverse Perspectives (PEDP) is required, reinforcing the importance of inclusivity in participant recruitment. The application process involves several milestones and performance-based goals to ensure timely trial execution and adherence to NCCIH’s research priorities. Institutions of various types, including higher education and non-profits, are eligible to apply, with an expectation of collaboration and adherence to federal and NIH guidelines. This funding opportunity reflects the commitment to rigorous scientific research while fostering diversity in clinical trial participation and management.
    Similar Opportunities
    Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Data Coordinating Center (DCC) for multi-site investigator-initiated clinical trials under funding opportunity PAR-22-193. This initiative aims to support trials that evaluate efficacy, comparative effectiveness, and implementation strategies relevant to the mission of the National Heart, Lung, and Blood Institute (NHLBI), emphasizing collaboration with a Clinical Coordinating Center (CCC). The DCC will be responsible for comprehensive project coordination, data management, and biostatistical support, ensuring adherence to participant safety and diverse population recruitment. Interested applicants must submit both DCC and CCC applications concurrently by September 11, 2025, and can seek early consultation with NIH staff for guidance. For further details, 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/pa-files/PAR-22-193.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.
    Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes - Data Coordinating Center (Collaborative U24 Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for a phased multi-site clinical trial aimed at preventing cardiovascular disease (CVD) in young adults with high lifetime risk, specifically through the establishment of a Data Coordinating Center (DCC). The DCC will be responsible for overall project coordination, administration, data management, and biostatistical support for the trial, which will evaluate the efficacy of pharmacological interventions against a control group while focusing on health equity and community engagement. This initiative is critical for addressing the rising incidence of CVD among young adults by employing innovative trial designs and strategies to enhance diverse perspectives. Applications are due by October 28, 2024, with a total budget allocation starting at $972,356 for fiscal year 2025, and interested applicants can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), is inviting applications for the "NCCIH Natural Product Mid Phase Clinical Trial (R01 Clinical Trial Required)" grant, aimed at advancing research on natural products such as botanicals and dietary supplements. This funding opportunity encourages mid-phase clinical trials that are hypothesis-driven, focusing on determining optimal dosing or identifying patient phenotypes for future efficacy studies, while explicitly excluding trials for cancer treatment. Eligible applicants include a diverse range of organizations, such as historically black colleges, tribal colleges, and community-based organizations, with a funding ceiling of $350,000 and a submission deadline of November 13, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/pa-files/PAR-24-115.html.
    The Road to Prevention of Stillbirth Data Coordinating Center (UM2 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for a cooperative agreement to establish the Data Coordinating Center (DCC) for the Stillbirth Research Consortium, aimed at reducing stillbirth rates, particularly among marginalized populations. The DCC will be responsible for managing data collection, providing technical support, and enhancing coordination among various research projects focused on stillbirth prevention. This funding opportunity underscores the federal government's commitment to addressing perinatal mortality through innovative research strategies and interdisciplinary collaboration. Interested applicants should note that the application submission period begins on October 1, 2024, with approximately $2.25 million available for FY 2025, and can direct inquiries to grantsinfo@nih.gov for further information.
    Notice of Intent to Publish a Funding Opportunity Announcement for Data Management and Coordinating Center (DMCC) for Rare Diseases Clinical Research Network (RDCRN) (U2C Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) plans to publish a Funding Opportunity Announcement (FOA) for the establishment of a Data Management and Coordinating Center (DMCC) as part of the Rare Diseases Clinical Research Network (RDCRN). This initiative aims to enhance the diagnosis, management, and treatment of rare diseases by facilitating collaborative, multi-site, patient-centric research through the RDCRN and supporting the activities of the Rare Diseases Clinical Research Consortia (RDCRC). The estimated total program funding for this grant is $1,000,000, with the FOA expected to be published in 2024 and awards anticipated in 2025. Interested applicants can reach out to Dr. Tiina K. Urv at urvtiin@mail.nih.gov or by phone at 301-827-2746 for further information.
    NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Center for Complementary and Integrative Health (NCCIH), invites applications for the NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33), aimed at supporting early-phase clinical trials of natural products such as botanicals and dietary supplements. This funding opportunity encourages research that evaluates the pharmacokinetics, safety, and efficacy of these natural products, with a focus on advancing promising interventions backed by prior scientific evidence. The program is designed to foster innovative clinical research that enhances understanding of the beneficial impacts of natural products on health conditions, while ensuring inclusivity through a Plan for Enhancing Diverse Perspectives (PEDP). Applicants may request up to $350,000 per year, with a project duration of up to six years contingent upon successful milestone completion, and the application deadline is November 13, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    Single Source for Chronic Pancreatitis Clinical Research Consortium (CPCRC) Data Coordinating Center (CPCRC-DCC) (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a cooperative agreement for the establishment of the Chronic Pancreatitis Clinical Research Consortium Data Coordinating Center (CPCRC-DCC) under funding opportunity RFA-DK-25-020. The primary objective is to facilitate ongoing studies on chronic pancreatitis, diabetes, and pancreatic cancer, focusing on data management, biomarker development, and clinical trial support for both pediatric and adult populations. This initiative is crucial for advancing the understanding of chronic pancreatitis and its associations with diabetes and pancreatic cancer, with an anticipated funding amount of $6.5 million over five years. Interested applicants must submit their proposals by 5:00 PM on October 19, 2024, and can direct inquiries to grantsinfo@nih.gov for further information.
    NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NCCIH Natural Product Early Phase Clinical Trial Award (R33), aimed at funding early phase clinical trials focused on natural products such as botanicals and dietary supplements. This funding opportunity encourages research that rigorously evaluates the effects of these products on specific biological targets, with a total budget limit of $1,050,000 in direct costs available for up to three years of support. The initiative is particularly relevant for addressing health issues like chronic pain and gastrointestinal disorders, emphasizing the importance of diverse research collaborations and methodologies. Interested applicants must comply with NIH grants policies and submit their proposals by November 13, 2026, while also enhancing research diversity through a Plan for Enhancing Diverse Perspectives (PEDP). For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    The Chronic Pancreatitis Clinical Research Consortium (CPCRC)- Clinical Centers (CPCRC-CCs) (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) for the Chronic Pancreatitis Clinical Research Consortium (CPCRC), inviting U01 applications for Clinical Centers to conduct research on chronic pancreatitis, diabetes, and pancreatic cancer. The initiative aims to continue the consortium's work by collecting clinical data and biospecimens to identify biomarkers for risk stratification and disease progression, ultimately enhancing understanding and treatment of these conditions. With an estimated funding of $6.5 million for the 2025 fiscal year, applications are due by October 18, 2024, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.