Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional) | PAR 19 325

Opportunity Information: Apply for PAR 19 325

The National Institutes of Health (NIH) funding opportunity titled "Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)" (Funding Opportunity Number PAR 19-325) is a discretionary grant program designed to support collaborative, research-driven projects focused on long-term health problems caused by cancer treatments. The central theme is that many patients survive cancer but later face persistent or delayed side effects from therapy that can turn into chronic conditions, reduce quality of life, and complicate long-term survivorship care. This FOA targets those therapy-related adverse sequelae that either do not resolve after treatment or emerge months to years later as late effects, and it encourages research that can move the field toward practical prevention or mitigation strategies grounded in a solid understanding of underlying biology.

A major goal of the FOA is to fund studies that explain why these adverse sequelae happen at a mechanistic level and how they evolve over time in real patients. NIH is looking for projects that can connect the dots between cancer treatment exposures (for example, chemotherapy, radiation, immunotherapy, targeted therapies, hormonal therapies, transplants, or multimodal regimens) and specific downstream toxicities that persist or appear later. The FOA explicitly welcomes basic, translational, and clinical research, but it places particular emphasis on mechanistic studies that include translational endpoints. In practice, that means proposals should not stop at describing a clinical syndrome or reporting prevalence; they should aim to identify causative pathways, mediators, risk factors, or biological processes that can be measured and eventually targeted by interventions.

Another key emphasis is careful clinical characterization using longitudinal approaches. The FOA encourages investigators to follow participants over time and to apply detailed clinical phenotyping so that adverse sequelae can be defined more precisely, staged more consistently, and measured in ways that are useful for future clinical trials. This includes developing and validating clinical endpoints that could later serve as trial outcomes. The endpoints the FOA calls out include biomarkers (such as blood-based markers, genetic or molecular signatures, immune or metabolic indicators), imaging measures (including modalities that can capture organ injury, inflammation, fibrosis, or functional change), patient-reported outcomes (to capture symptoms and functional impact directly from survivors), or composite endpoints that combine multiple elements into a more reliable measure of toxicity burden. The point is to create endpoints that are not only scientifically meaningful, but also feasible and robust enough to support intervention testing later on.

The opportunity also supports translating mechanistic insights into therapeutic approaches, with the intent of preventing, minimizing, or otherwise reducing the risk and severity of long-term sequelae. The FOA is positioned to move research beyond observation and toward strategy, encouraging applicants to use mechanistic understanding to identify intervention targets and to propose approaches that could reasonably be developed into prevention or mitigation therapies. Because the announcement is labeled "Clinical Trial Optional," applicants have flexibility: projects may include a clinical trial component if it is appropriate and well-justified, but a trial is not mandatory. This allows both earlier-stage mechanistic and endpoint-validation work, as well as intervention-oriented studies, as long as the overall project aligns with the FOA's focus on long-term therapy-induced complications and mechanistically informed solutions.

Administratively, this is an NIH R01 grant mechanism, which typically supports substantial, multi-year research projects with defined aims and a strong scientific premise. The funding activity falls under Education and Health, with CFDA numbers 93.395, 93.396, and 93.399. The FOA lists an original closing date of 2022-02-11 in the provided source information. No award ceiling or expected number of awards is specified in the excerpted data, which usually means applicants need to refer to the full FOA text or NIH guidance for budgeting norms and institute-specific expectations.

Eligibility is broad and intentionally inclusive, reflecting NIH's interest in reaching diverse institutions and communities and supporting research that can generalize across populations. Eligible applicants include many levels of government entities (state, county, city or township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, and tribal organizations that are not federally recognized. It also includes public housing authorities and Indian housing authorities, nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses. In addition, the FOA specifically highlights other eligible applicants such as Alaska Native and Native Hawaiian 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. (foreign) entities. This broad eligibility signals that NIH is open to multidisciplinary, multi-institutional teams and to research settings that can capture different survivor populations and care contexts.

Overall, the FOA is best understood as a push to improve survivorship science by treating chronic and delayed toxicities as a serious and addressable consequence of cancer therapy. NIH is encouraging projects that combine strong mechanistic reasoning with real-world clinical observation over time, and that produce measurable endpoints that can be carried forward into future clinical trials. The strongest fit will be collaborative proposals that can bridge laboratory insights, translational measurement tools, and longitudinal patient characterization, ultimately laying the groundwork for interventions that prevent or lessen long-term harm from otherwise life-saving cancer treatments.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (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, 93.396, 93.399.
• This funding opportunity was created on 2019-07-30.
• Applicants must submit their applications by 2022-02-11. (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 PAR 19 325

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