Oral Anticancer Agents: Utilization, Adherence, and Health Care Delivery (R01 Clinical Trial Optional) | PA 18 004

Opportunity Information: Apply for PA 18 004

The National Institutes of Health (NIH) funding opportunity announcement PA 18-004, titled "Oral Anticancer Agents: Utilization, Adherence, and Health Care Delivery (R01 Clinical Trial Optional)," supports research aimed at improving how oral anticancer medications are used, delivered, and adhered to in real-world settings. Oral anticancer agents have shifted a significant portion of cancer treatment from tightly supervised infusion clinics to the home and community, which can create new safety, monitoring, communication, and equity challenges. This FOA is designed to generate evidence that clarifies what is happening now in everyday care, why adherence problems occur, and what practical models or strategies can improve safe and effective use so that patient outcomes are optimized.

A central focus of the announcement is threefold: first, to assess and clearly describe the current state of oral anticancer medication utilization, delivery, and adherence, including how these drugs are prescribed, accessed, taken, and monitored across different care settings. Second, it seeks to identify barriers that interfere with adherence and appropriate use, especially barriers that are structural (such as insurance coverage, pharmacy benefit design, high out-of-pocket costs, transportation, or geographic access), systemic (like fragmented care coordination, communication gaps between oncology and primary care, prior authorization delays, or limited follow-up infrastructure), and psychosocial (including health literacy, beliefs about medications, depression, caregiver burden, stigma, or competing life demands). Third, the FOA encourages the development and testing of models, interventions, or implementation strategies that measurably improve the delivery and ongoing management of these therapies, with the end goal of improving clinical outcomes and minimizing preventable harm.

The FOA emphasizes that applications should anchor their research questions in at least one targeted area: either a specific cancer type, a specific class of oral anticancer drugs, and/or populations that experience disparities in cancer care and outcomes. Examples of disparity-focused groups explicitly highlighted include older adults, people with low socioeconomic status, and racial or ethnic minority populations, but the intent is broader: applicants are expected to be deliberate about why their chosen population or clinical context is at risk for access barriers, reduced adherence, or poorer outcomes, and how the proposed research can produce actionable knowledge to reduce those gaps.

NIH allows projects to be designed at multiple levels of influence, reflecting the reality that adherence and safe use are not solely patient behaviors. Research may focus on the patient (pediatric, adolescent, or adult), the patient-caregiver dyad, clinicians and prescribing behaviors, the broader health care team (including nursing, pharmacy, social work, and navigation), or the health care delivery system itself (such as oncology practices, integrated delivery networks, specialty pharmacies, or payer-driven medication management structures). This supports a wide range of study designs, including intervention studies that test solutions, observational studies that document patterns and predictors, and mixed-methods work that combines quantitative measures with qualitative insights from patients, caregivers, and providers. For observational research in particular, the FOA signals a preference for studies that identify modifiable risk factors, meaning findings should point toward factors that can realistically be changed through future interventions rather than merely describing unchangeable correlates.

The award mechanism is an R01 research project grant, with clinical trials listed as optional, meaning applicants can propose either non-trial research or clinical trial work if appropriate to their aims. The opportunity falls under the NIH health and education funding activity category and is associated with CFDA number 93.395. The original posting date was November 3, 2017, and the original closing date listed in the source data is January 7, 2020.

Eligibility is broad and includes many types of organizations that can contribute to this work. Domestic applicants include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; public and Indian housing authorities; federally recognized Native American tribal governments; and Native American tribal organizations that are not federally recognized. Nonprofits are eligible whether or not they hold 501(c)(3) status, and for-profit organizations are eligible as well (other than small businesses, which are also separately listed as eligible). The FOA also explicitly notes additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs). Faith-based and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations) are also included, reinforcing the NIH interest in solutions that can be tested across diverse health care contexts and populations.

Overall, the grant opportunity is aimed at building a stronger evidence base for how oral anticancer therapies are actually managed outside of controlled trial environments, why patients may struggle to start or stay on therapy as intended, and what health system or care-delivery changes can improve adherence, safety, and outcomes. It encourages applicants to treat oral anticancer adherence as a multi-level challenge tied to access, care coordination, patient support, and structural inequities, rather than only a question of individual compliance.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Oral Anticancer Agents: Utilization, Adherence, and Health Care Delivery (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
• This funding opportunity was created on 2017-11-03.
• Applicants must submit their applications by 2020-01-07. (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 PA 18 004

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