Leveraging Existing Large Databases and Cohorts to Better Understand the Risks and Benefits of Long-Term Osteoporosis Therapy and Drug Holiday (R01 Clinical Trial Not Allowed) | RFA AG 22 018

Opportunity Information: Apply for RFA AG 22 018

The National Institutes of Health (NIH) issued this Funding Opportunity Announcement (FOA), RFA-AG-22-018, titled "Leveraging Existing Large Databases and Cohorts to Better Understand the Risks and Benefits of Long-Term Osteoporosis Therapy and Drug Holiday (R01 Clinical Trial Not Allowed)." The main goal is to fund research that uses secondary analyses of already-existing large datasets, cohorts, registries, or administrative databases to improve the evidence base for how long-term osteoporosis treatments should be managed over time. A central theme is clarifying when continued therapy is beneficial, when it may be safer or reasonable to pause treatment (a "drug holiday"), and what the real-world risks and benefits look like across different patient groups.

This opportunity focuses on osteoporosis therapies used over extended periods, where clinicians and patients often face difficult tradeoffs. Long-term treatment can reduce fracture risk, but certain medications may also be associated with rare or delayed adverse outcomes, and treatment effects can change over time. Drug holidays are sometimes used in practice, yet the best timing, duration, and patient selection criteria are not fully established. The FOA is intended to support analyses that can address these kinds of practical, high-impact questions by taking advantage of large-scale existing data resources rather than launching new clinical trials.

The award mechanism is an NIH R01 research project grant, and the FOA explicitly states "Clinical Trial Not Allowed," meaning applicants are expected to perform observational or other non-interventional research using existing data rather than enrolling participants into a new trial or assigning interventions. The research activity category is health, and the associated CFDA numbers listed are 93.846 and 93.866. The funding instrument type is a grant, and the opportunity category is discretionary.

In terms of scale, the FOA lists an award ceiling of $750,000. The posting also includes an original closing date of October 28, 2021, with a creation date of June 17, 2021. While the expected number of awards is not specified in the provided excerpt, the intent is clearly to stimulate multiple rigorous analyses that collectively strengthen guidance on long-term therapy strategies and drug holiday decisions.

Eligibility is broad and includes many organization types that commonly apply for NIH funding. 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; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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; eligible federal agencies; regional organizations; U.S. territories or possessions; and non-U.S. entities (foreign organizations). This wide eligibility suggests NIH is encouraging participation from diverse research settings and institutions, including those serving populations that may be underrepresented in research.

Overall, this grant opportunity is aimed at producing actionable, clinically relevant evidence about long-term osteoporosis medication management by analyzing existing large-scale data. It is designed for investigators who can leverage established databases and cohorts to answer questions about sustained treatment versus stopping or pausing therapy, identify which patients benefit most or face higher risks, and help inform real-world decision-making without conducting a new clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Leveraging Existing Large Databases and Cohorts to Better Understand the Risks and Benefits of Long-Term Osteoporosis Therapy and Drug Holiday (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846, 93.866.
• This funding opportunity was created on 2021-06-17.
• Applicants must submit their applications by 2021-10-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $750,000.00 in funding.
• 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 22 018

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