Oral Anticancer Agents: Utilization, Adherence, and Health Care Delivery (R21 Clinical Trial Optional) | PA 18 014

Opportunity Information: Apply for PA 18 014

The National Institutes of Health (NIH) funding opportunity Oral Anticancer Agents: Utilization, Adherence, and Health Care Delivery (R21 Clinical Trial Optional), PA 18 014, supports exploratory and developmental research aimed at improving how oral anticancer medications are used, delivered, and taken in real-world settings. It is designed for early-stage, hypothesis-generating projects that can map the current landscape of oral anticancer therapy and quickly test promising ideas, models, or strategies that could later be expanded into larger studies. The central goal is to optimize clinical outcomes by addressing the practical and human challenges that come with shifting cancer treatment from supervised infusion settings to the home, where patients and caregivers often carry much of the responsibility for correct dosing, safety, and ongoing management.

The FOA emphasizes three linked research priorities. First, it encourages studies that assess and clearly describe the current state of oral anticancer agent utilization, medication delivery processes, and adherence patterns, including how these differ across settings and populations. Second, it calls for work that identifies barriers to adherence and safe use, with a strong focus on structural, systemic, and psychosocial factors. This can include issues like access and affordability, insurance design and pharmacy benefit hurdles, fragmentation between oncology and primary care, complexity of dosing schedules, side effect burden, health literacy, language access, transportation constraints for monitoring visits, stigma, stress, depression, cognitive impairment, and the competing demands patients face at home and work. Third, it supports development of practical models and strategies that improve the safe and effective delivery of these drugs, such as new care pathways, monitoring approaches, coordination mechanisms, patient support systems, or technology-enabled tools, with the expectation that these advances will translate into better outcomes.

Applicants are expected to focus their research questions on at least one specific cancer type, class of oral anticancer drugs, and/or populations that experience disparities in care. The FOA explicitly highlights disparity-relevant groups such as older adults, people with low socioeconomic status, and racial or ethnic minority populations, but the intent is broader: projects should be deliberate about where inequities exist in access, adherence support, toxicity management, follow-up, and clinical outcomes, and should explore why those gaps persist and what can realistically be done to close them. Studies can target pediatric, adolescent, or adult patients, and may also look at the patient-caregiver dynamic, especially when caregivers help manage medication schedules, monitor symptoms, or navigate refills and insurance approvals.

The opportunity is flexible about the level of intervention and the research design, which is typical for an R21 mechanism. Research may be conducted at the patient level, the provider or clinic level, the broader health care team level, or across the health care delivery system. The FOA allows intervention studies, observational studies, and mixed-methods work. Observational projects are expected to go beyond description by emphasizing modifiable risk factors that can be addressed in future intervention research, for example identifying points in the care pathway where communication fails, where refills are delayed, where toxicity is underreported, or where adherence declines because of side effects, cost, or misunderstanding. Because clinical trials are optional, applicants can propose either non-trial studies (like implementation-focused observational analyses, qualitative interviews, claims/EHR analyses, workflow assessments, or feasibility studies) or early-stage trials that test a strategy to improve adherence and safe delivery.

In terms of funding details, this is a discretionary NIH grant in the Education and Health activity category, associated with CFDA number 93.395. The listed award ceiling is $200,000, reflecting the smaller, exploratory nature of R21 awards. The original closing date shown in the source information is January 7, 2020, and the FOA was created on November 3, 2017, so anyone interested today would need to verify whether NIH has reissued, extended, or replaced this announcement with a more current version.

Eligibility is broad and includes many types of organizations that can contribute to cancer care delivery research. Eligible applicants include state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. It also includes Native American tribal governments (federally recognized), tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, and several categories of mission-driven institutions and community-based entities. The FOA explicitly notes additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIS institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and even non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that adherence and medication delivery problems are not only clinical issues; they sit at the intersection of health systems, communities, policy, and everyday life, and solutions often require partnerships across many types of institutions.

Overall, the grant opportunity is aimed at strengthening the evidence base around oral anticancer therapy in routine practice: how these medications are started, paid for, monitored, and continued; why adherence breaks down; and what can be built into care delivery to make oral therapy safer and more effective, especially for populations that face disproportionate barriers. The emphasis on modifiable factors, real-world care pathways, and disparity-focused questions signals that NIH is looking for projects with a clear line of sight from measurement and insight to practical strategies that clinics, health systems, and communities can actually implement.

• 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 (R21 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.)
• Each selected applicant is eligible to receive up to $200,000.00 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.

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