Clinical Trial on Effects of Statins in Older Adults without Clinical Cardiovascular Disease (U19 Clinical Trial Required) | RFA AG 19 020

Opportunity Information: Apply for RFA AG 19 020

The National Institutes of Health (NIH), through the National Institute on Aging (NIA) and the National Heart, Lung, and Blood Institute (NHLBI), issued this funding opportunity (RFA-AG-19-020) to support a large, seven-year pragmatic clinical trial focused on statin therapy in adults age 75 and older who do not have clinical cardiovascular disease. The central goal is to generate clear, real-world evidence on the overall balance of benefits and risks of statins in this older population, where clinical decisions can be complicated by age-related factors, multiple chronic conditions, and concerns about side effects. The trial is described as pragmatic, meaning it is intended to be embedded in routine health care delivery as much as possible and to produce results that are directly applicable to everyday clinical practice rather than tightly controlled, highly selective research settings.

The award mechanism is a U19 cooperative agreement, which generally means the project will be carried out as a coordinated, multi-component program with substantial scientific involvement from NIH staff during the life of the award. This particular announcement calls for applications that bring together a network or consortium of health care delivery systems (HCS) spanning most U.S. geographic regions, along with a dedicated data coordinating center. In practice, this points to a large-scale partnership capable of enrolling and following a geographically and demographically diverse group of older adults, capturing outcomes efficiently through clinical workflows and electronic health records, and maintaining consistent study procedures across multiple systems.

The scientific focus is adults 75 years of age and older without clinical cardiovascular disease, with the trial designed to assess both potential benefits (such as prevention of cardiovascular events) and potential harms or tradeoffs (such as adverse effects, tolerability issues, or other safety and quality-of-life considerations relevant to older adults). By emphasizing “overall risks and benefits,” the opportunity signals an interest in comprehensive outcome assessment rather than a narrow endpoint, consistent with the realities of decision-making in geriatric care.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized) and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status, excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also explicitly highlights additional applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. This emphasis suggests a desire to encourage participation from institutions serving diverse populations and from organizations that can improve representativeness and reach.

At the same time, the opportunity places clear restrictions on foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. The intent is for the work, infrastructure, and participating components of the project to be entirely U.S.-based.

Administratively, the opportunity is categorized as discretionary funding and falls under the health activity category, with CFDA numbers 93.837, 93.853, and 93.866. The original closing date listed is February 4, 2019, and the opportunity was created on August 8, 2018. While an award ceiling and expected number of awards are not specified in the provided text, the scale and duration described (a seven-year, multi-system pragmatic clinical trial with a data coordinating center) imply a major, resource-intensive effort requiring robust operational capacity, strong coordination across health care systems, and mature data management and trial governance capabilities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trial on Effects of Statins in Older Adults without Clinical Cardiovascular Disease (U19 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837, 93.853, 93.866.
• This funding opportunity was created on 2018-08-08.
• Applicants must submit their applications by 2019-02-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AG 19 020

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