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

Original Source

https://grants.gov/search-results-detail/355311

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-25-007.html
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
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-HL-25-007-Full-Announcement.html
    RFA-HL-25-007.html
    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
    Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes - Clinical Coordinating Center (Collaborative UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for a phased multi-site clinical trial aimed at preventing cardiovascular disease (CVD) in young adults with a high lifetime risk, utilizing surrogate outcomes. The primary objective is to establish a Clinical Coordinating Center (CCC) to manage a trial that will screen eligible participants and evaluate interventions to reduce the progression of coronary atherosclerosis among individuals aged 50 and younger, or women over 50. This initiative is significant as it seeks to address critical knowledge gaps regarding the impact of early treatment on subclinical CVD, while also enhancing inclusivity in research participation. Interested applicants should note that the total funding commitment may exceed $30 million, with a maximum project duration of seven years, and the application deadline is October 28, 2024. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    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.
    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.
    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 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.
    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.
    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.
    Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the Coordinating Center for Type 1 Diabetes TrialNet (TNCC) through a cooperative agreement, aimed at supporting research initiatives focused on the prevention and intervention of type 1 diabetes (T1D). The TNCC will manage a variety of research projects, oversee data and sample management, and facilitate the selection of clinical centers necessary for conducting clinical studies related to T1D. This initiative underscores the federal commitment to advancing T1D research and treatment, with a total funding availability of approximately $29.5 million. Interested applicants must submit their proposals by October 17, 2024, and are required to include a Plan for Enhancing Diverse Perspectives (PEDP) as part of their application. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.