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)
ID: 355311Type: 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 phased multi-site clinical trial aimed at preventing cardiovascular disease in young adults with high lifetime risk, specifically targeting men under 50 and women over 50. The initiative requires the development of a Data Coordinating Center (DCC) to provide project coordination, administration, data management, and biostatistical support for the trial, which will test interventions to reduce the progression of coronary atherosclerosis. This comprehensive effort, with approximately $8 million in total funding available over multiple years, aims to address significant knowledge gaps in early treatment of cardiovascular risks and improve health outcomes for young adults. Interested applicants must submit their proposals by October 28, 2024, and are encouraged to contact 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), is offering a funding opportunity for a phased multi-site clinical trial aimed at preventing cardiovascular disease in young adults at high lifetime risk. The initiative focuses on a population with a low 10-year risk of cardiovascular events but a high lifetime risk, defined as men under 50 and women over 50. The trial will test interventions to reduce the progression of coronary atherosclerosis, utilizing a two-component primary prevention model: screening eligible participants and assessing the efficacy of pharmacological and behavioral interventions. The opportunities include developing a Data Coordinating Center (DCC) that will facilitate project coordination, administration, data management, and statistical support essential for the trial's success. Applicants must submit a collaborative proposal with a Clinical Coordinating Center (CCC) application by specified deadlines, and adherence to a Plan for Enhancing Diverse Perspectives (PEDP) is mandatory to promote inclusivity and engagement. The total funds available for the project over multiple years amount to approximately $8 million, with direct application budgets capped for each fiscal year. This comprehensive initiative aims to close significant knowledge gaps in early treatment of cardiovascular risks, potentially leading to changes in clinical practices and improved health outcomes for young adults.
    Similar Opportunities
    Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 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 a Data Coordinating Center (DCC) to support multi-site, investigator-initiated clinical trials focused on mind and body interventions. The DCC will be responsible for project coordination, administrative support, data management, and biostatistical analysis for Phase III clinical trials, and must be submitted alongside a Clinical Coordinating Center (CCC) proposal. This initiative is crucial for advancing research in complementary and integrative health strategies that address public health challenges, emphasizing participant diversity and data integrity. Interested applicants should note that the application deadline is January 20, 2025, with a funding period of up to 7 years, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    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.
    Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the Natural Product Multi-Site Clinical Trial Data Coordinating Center (DCC) through a cooperative agreement mechanism. This initiative invites applications for a DCC that will collaborate with a Clinical Coordinating Center (CCC) to conduct multi-site clinical trials focused on the efficacy and effectiveness of natural products, requiring simultaneous submission of both applications. The program emphasizes the importance of maintaining data integrity, promoting diversity in participant recruitment, and achieving specific milestones for continued funding, while also necessitating a Plan for Enhancing Diverse Perspectives (PEDP) to ensure inclusivity in research. Interested applicants can find more information and application details on the NIH grants website, with a submission deadline of July 14, 2026, and a contact email for inquiries at grantsinfo@nih.gov.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for cooperative agreements to establish a Clinical Coordinating Center (CCC) for multi-site, investigator-initiated clinical trials focused on the effects of natural products, such as botanicals and dietary supplements. Applicants are required to develop a comprehensive scientific and operational plan for the clinical trial, including project management, participant recruitment, and performance milestones, while also submitting a companion Data Coordinating Center (DCC) application. This initiative aims to generate robust clinical data to inform integrative health approaches and public health strategies, with applications opening on January 20, 2025, and closing on July 14, 2026. For further details, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-312.html.
    NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is offering a funding opportunity for high-risk multi-center clinical study implementation planning via Cooperative Agreements (U34). This initiative aims to support the early peer review of proposed clinical studies, assess study designs, and develop essential documentation, including operational manuals, focusing on diseases relevant to NIDDK's mission. The program emphasizes health equity and inclusivity, requiring a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Interested applicants can apply for up to $225,000 per year for a maximum of two years, with the application submission period opening on September 9, 2024, and the closing date set for June 10, 2027. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.
    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) has announced a Notice of Funding Opportunity (NOFO) for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials under the UG3/UH3 cooperative agreement mechanism. This initiative aims to facilitate trials focused on efficacy, comparative effectiveness, and implementation research, particularly those that address health disparities and promote community engagement. Eligible applicants include a diverse range of organizations, such as academic institutions, nonprofit entities, and tribal governments, with applications required to detail project management, participant recruitment strategies, and a Plan for Enhancing Diverse Perspectives (PEDP). The application period opens on January 11, 2025, with a submission deadline of September 11, 2025, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 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 offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on mind and body interventions. Applicants are required to develop comprehensive plans that include project management, participant recruitment, and data analysis, while collaborating with a corresponding Data Coordinating Center (DCC) to ensure the trials are scientifically robust and aligned with NCCIH's research priorities. This initiative aims to explore the efficacy and effectiveness of complementary health approaches, emphasizing the inclusion of diverse populations and the necessity for a detailed plan to enhance diversity in research teams and subjects. Interested applicants must submit their proposals by January 20, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For more details, please refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-275.html.
    Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the establishment of a Clinical Coordinating Center (CCC) to support multi-site investigator-initiated clinical trials focused on natural products, such as botanicals and dietary supplements. Applicants are required to submit a comprehensive plan detailing project management, participant recruitment, and clinical trial execution, while also ensuring alignment with NIH standards. This initiative emphasizes the importance of evidence-based research in natural products and mandates the submission of a corresponding Data Coordinating Center (DCC) proposal to oversee data management and analysis. Interested applicants should note that the application deadline is July 15, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For additional details, applicants can refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-24-123.html.
    NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01), aimed at supporting high-risk observational studies related to diabetes, digestive, kidney, and metabolic diseases. Applicants must complete all planning activities prior to submission, as these cannot be included in the U01 application, and a Plan for Enhancing Diverse Perspectives (PEDP) is mandatory for consideration. This funding opportunity is crucial for advancing clinical research and addressing health disparities, particularly by encouraging collaboration with underrepresented communities. Interested applicants should note that the application deadline is February 5, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01), aimed at supporting investigator-initiated, high-risk clinical trials that involve multiple clinical centers. Applicants must propose hypothesis-driven studies that focus on diseases relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with an emphasis on enhancing diverse perspectives in research. This funding opportunity is crucial for advancing therapeutic studies that can significantly improve clinical practices and public health outcomes. Interested applicants should note that the application period opens on January 5, 2024, with a closing date of November 5, 2026, and are encouraged to consult with NIDDK staff prior to submission. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.