Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional) | PAR 25 145

Opportunity Information: Apply for PAR 25 145

The National Institutes of Health (NIH) funding opportunity PAR-25-145, titled "Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)," supports collaborative research aimed at understanding and reducing the long-term health problems that can follow cancer treatment. The core focus is on adverse sequelae caused by cancer therapies that either persist after treatment and become chronic comorbidities or emerge later as delayed post-treatment effects. Rather than concentrating on short-term side effects that resolve quickly, this announcement is geared toward the lasting or late-developing conditions that can affect survivors for years and meaningfully reduce quality of life.

The FOA encourages a broad range of research, including basic, translational, and clinical studies, as long as the work is tightly connected to clarifying mechanisms and linking those mechanisms to clinically meaningful measures. Projects may aim to identify the biological, physiological, or molecular mechanisms behind therapy-induced sequelae, to clinically characterize how these sequelae present and evolve over time, or to translate mechanistic insights into strategies that prevent, minimize, or otherwise mitigate long-term damage. The emphasis is on mechanistic understanding that can realistically inform intervention development, not simply cataloging symptoms without a pathway to actionable targets.

A major expectation is that proposed studies include longitudinal clinical phenotyping, meaning careful, repeated characterization of patients over time to capture how adverse sequelae develop, persist, or worsen. This can involve deep clinical assessments and the integration of multiple measurement types, such as biomarkers, imaging-based measures, and patient-reported outcomes (PROs). The goal is to identify and validate clinical endpoints that are robust enough to be used later in clinical trials. In practical terms, the FOA is trying to strengthen the bridge between mechanistic science and future intervention testing by ensuring the field has reliable endpoints for determining whether an intervention truly prevents or reduces a specific therapy-related long-term condition.

The announcement also highlights translational endpoints, signaling that even when the work is mechanistic, it should connect to outputs that can be carried forward into human studies or clinical trial design. For example, a project could explore mechanistic drivers of a chronic therapy-induced condition while simultaneously developing and validating a biomarker panel or imaging signature that tracks disease trajectory and response potential. Clinical trials are optional under this R01, meaning applicants can propose studies that include a clinical trial component, but they are not required to do so. This gives flexibility for teams that are still in the characterization or endpoint-validation stage, as well as those prepared to move toward intervention-oriented testing.

From an eligibility standpoint, the FOA is widely open, reflecting NIH's broad applicant landscape. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public housing authorities/Indian housing authorities, tribal governments (federally recognized), and tribal organizations (including those other than federally recognized tribal governments). Higher education institutions are eligible across categories (public/state-controlled and private), and both nonprofit organizations (with or without 501(c)(3) status) and for-profit organizations (other than small businesses) may apply, along with small businesses. The FOA explicitly notes additional eligible groups 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, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities/foreign organizations, and U.S. territories or possessions. This breadth supports participation from diverse institutions and communities, including those historically underrepresented in biomedical research.

Administratively, this is a discretionary grant opportunity using the NIH R01 mechanism, and it falls under the Health (and related Education/Health) activity category, with CFDA number 93.393. The opportunity was created on 2024-11-06, and the original closing date listed is 2028-01-07. The listing does not specify an award ceiling or expected number of awards in the provided source details, which often means applicants should consult the full FOA text and NIH Institute/Center guidance for budget expectations, scope alignment, and review considerations.

Overall, PAR-25-145 is designed for teams that can bring together mechanistic biology, clinical insight, and rigorous longitudinal measurement to tackle the long-term consequences of cancer therapy. The most competitive projects will typically be those that not only explain why a therapy-induced sequela occurs, but also produce validated, trial-ready endpoints and a credible path toward mechanism-based interventions that could ultimately improve long-term survivorship outcomes.

• 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): 93.393.
• This funding opportunity was created on 2024-11-06.
• Applicants must submit their applications by 2028-01-07.
• 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 25 145

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