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.Apply for PAR 25 145
- 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.
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Frequently Asked Questions (FAQs)
What is PAR-25-145?
PAR-25-145 is an NIH funding opportunity titled "Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)." It supports collaborative research focused on understanding and reducing long-term health problems that can follow cancer treatment.
What problem is this funding opportunity trying to address?
The focus is on adverse sequelae from cancer therapies that either (1) persist after treatment and become chronic comorbidities or (2) emerge later as delayed post-treatment effects. The goal is to address lasting or late-developing conditions that can affect survivors for years and reduce quality of life.
Does this FOA focus on short-term side effects during cancer treatment?
No. This opportunity is not centered on short-term side effects that resolve quickly. It is aimed at conditions that persist long after treatment or appear later as delayed effects.
What types of research are encouraged?
The FOA encourages a broad range of research approaches, 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.
What kinds of project goals fit this FOA?
Projects may aim to:
- Identify biological, physiological, or molecular mechanisms behind therapy-induced adverse sequelae
- Clinically characterize how sequelae present and evolve over time
- Translate mechanistic insights into strategies that prevent, minimize, or mitigate long-term damage
Is simply cataloging symptoms enough for a competitive application?
The FOA emphasizes mechanistic understanding that can realistically inform intervention development. It is not geared toward projects that only catalog symptoms without a pathway to actionable targets.
What is meant by "longitudinal clinical phenotyping" in this FOA?
Longitudinal clinical phenotyping refers to careful, repeated characterization of patients over time to capture how therapy-induced adverse sequelae develop, persist, worsen, or emerge as delayed effects.
What types of measurements can be included in longitudinal phenotyping?
The FOA describes integrating multiple measurement types, which may include biomarkers, imaging-based measures, and patient-reported outcomes (PROs), alongside deep clinical assessments.
Why does the FOA emphasize clinical endpoints?
A key goal is to identify and validate clinical endpoints that are robust enough to be used later in clinical trials. This is intended to strengthen the bridge between mechanistic science and future intervention testing.
What are "translational endpoints" in the context of this opportunity?
Translational endpoints are outputs that can be carried forward into human studies or clinical trial design. Even when a project is mechanistic, the FOA highlights the importance of connecting the work to endpoints that support translation toward interventions.
Can you give an example of what a translationally oriented mechanistic project might include?
One example described is a project that explores mechanistic drivers of a chronic therapy-induced condition while also developing and validating a biomarker panel or an imaging signature to track disease trajectory and potential response.
Are clinical trials required under this opportunity?
No. Clinical trials are optional under this R01. Applicants may include a clinical trial component, but it is not required.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include a wide range of domestic and non-domestic organizations across government, education, nonprofit, and for-profit sectors.
Are government entities eligible?
Yes. Eligible government applicants include state governments, county governments, city or township governments, and special district governments. Independent school districts are also eligible.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments are eligible, and tribal organizations (including those other than federally recognized tribal governments) are also listed as eligible.
Are colleges and universities eligible?
Yes. Higher education institutions are eligible, including public/state-controlled institutions and private institutions.
Are minority-serving institutions (MSIs) included as eligible applicants?
Yes. The FOA explicitly notes eligibility for several categories of MSIs, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and related eligible entities.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status are eligible to apply.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) may apply, and small businesses are also eligible.
Are faith-based or community-based organizations eligible?
Yes. Faith-based and community-based organizations are explicitly included among eligible applicants.
Can federal agencies apply?
Yes. Eligible federal agencies are listed among the eligible applicant types.
Are non-U.S. organizations eligible to apply?
Yes. Non-domestic (non-U.S.) entities and foreign organizations are listed as eligible.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included among eligible applicants.
What grant mechanism does this opportunity use?
This is a discretionary grant opportunity using the NIH R01 mechanism.
What is the activity category and CFDA number?
The activity category is Health (and related Education/Health), and the CFDA number listed is 93.393.
When was this opportunity created, and what is the listed closing date?
The opportunity was created on 2024-11-06. The original closing date listed is 2028-01-07.
Does the listing provide an award ceiling or the expected number of awards?
No. The provided source details do not specify an award ceiling or an expected number of awards. The listing suggests applicants may need to consult the full FOA text and relevant NIH Institute/Center guidance for budget expectations, scope alignment, and review considerations.
What kinds of teams are a good fit for this FOA?
This FOA is designed for teams that can integrate mechanistic biology, clinical insight, and rigorous longitudinal measurement to tackle long-term consequences of cancer therapy.
What characteristics are implied for a strong application?
The description emphasizes projects that not only explain why a therapy-induced sequela occurs, but also produce validated, trial-ready endpoints and outline a credible path toward mechanism-based interventions aimed at improving long-term survivorship outcomes.
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| Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional) Apply for PAR 25 170 Funding Number: PAR 25 170 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Tobacco, Alcohol, and Cannabis Policy Research for Health Equity (R21 Clinical Trial Optional) Apply for PAR 25 241 Funding Number: PAR 25 241 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Tobacco, Alcohol, and Cannabis Policy Research for Health Equity (R01 Clinical Trial Optional) Apply for PAR 25 240 Funding Number: PAR 25 240 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
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| Impacts of climate change across the cancer control continuum (R01 Clinical Trial Optional) Apply for PAR 25 094 Funding Number: PAR 25 094 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Mentored Research Scientist Development Award to Promote Diversity (K01 Independent Clinical Trial Not Allowed) Apply for PAR 24 316 Funding Number: PAR 24 316 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NIDA Research Education Program for Clinical Researchers and Clinicians (R25 Clinical Trial Not Allowed) Apply for PAR 25 204 Funding Number: PAR 25 204 Agency: National Institutes of Health Category: Education, Health Funding Amount: $350,000 |
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