NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) | PAR 25 139

Frequently Asked Questions (FAQs): NCI Clinical and Translational Exploratory/Developmental Studies (R21) - PAR-25-139

1) What is this funding opportunity?

This opportunity is the National Cancer Institute (NCI) Clinical and Translational Exploratory/Developmental Studies award under the NIH R21 mechanism (Clinical Trial Optional). The notice of funding opportunity (NOFO) is PAR-25-139.

2) What is the main goal of PAR-25-139?

The main goal is to support early-stage, high-impact cancer research that is exploratory or developmental in nature, with an emphasis on generating promising new directions, preliminary evidence, or proof-of-concept results that can enable larger and more definitive studies later.

3) What kind of research stage is this designed for?

This program is designed for projects that are still in an exploratory or developmental phase, where the work is intended to establish feasibility, produce enabling data, or demonstrate proof of concept rather than deliver final, large-scale confirmatory results.

4) Why does this use the R21 mechanism?

The R21 mechanism is intended to support exploratory and developmental research, including projects that may carry higher risk than typical grants but have a realistic chance of producing a breakthrough, new technology, or novel approach that could shift how cancer is studied or treated.

5) Is a clinical trial required?

No. The opportunity is designated "Clinical Trial Optional," meaning an application may include a clinical trial, but a clinical trial is not required.

6) If clinical trials are optional, what types of studies can be proposed?

Applicants may propose preclinical-to-clinical translational projects or early clinical explorations, depending on what is needed to move the concept forward.

7) What scientific areas does NCI emphasize for this award?

The scope is broad but centered on clinical and translational cancer research, including cancer diagnosis, treatment, imaging, symptom management and toxicity, and prevention.

8) What types of projects related to clinical trials are encouraged?

The NOFO highlights work that supports or accelerates clinical trials and therapeutic development, including correlative studies linked to clinical trials.

9) Does this opportunity support development of new therapies or prevention approaches?

Yes. It includes development of novel cancer therapeutics or preventive agents, as well as development of symptom/toxicity interventions.

10) Is radiotherapy research included?

Yes. The NOFO specifically highlights radiotherapy development activities as an area of interest.

11) What are "mechanism-driven combination strategies" in this context?

The opportunity signals interest in rational combination strategies that are grounded in biological mechanisms, rather than combinations chosen primarily by trial-and-error pairing.

12) Are preclinical studies allowed?

Yes. The NOFO supports innovative preclinical studies that are strongly clinically relevant, particularly those using next-generation models and advanced imaging technologies.

13) How clinically relevant should preclinical work be?

Preclinical efforts are expected to be positioned to inform translation to humans, with potential to lead toward first-in-human clinical trials when appropriate.

14) What outcomes is NCI looking for from funded projects?

The program aims to enable new agents, methods, tools, models, or applications that can substantially impact cancer research and ultimately patient outcomes, whether the work is primarily preclinical, clinical, or bridges the two.

15) Who can apply for this funding?

Eligibility is broad and includes many organization types across government, education, nonprofit, and for-profit sectors, including U.S. and non-U.S. (foreign) organizations.

16) What government entities are eligible applicants?

Eligible government applicants include federal, state, county, city, township, and special district governments, as well as Native American tribal governments (federally recognized).

17) Are tribal organizations eligible if they are not federally recognized?

Yes. Tribal organizations that are not federally recognized are explicitly included as eligible applicants.

18) Are schools and universities eligible?

Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.

19) Are nonprofits eligible?

Yes. Eligible applicants include nonprofit organizations, including both 501(c)(3) and non-501(c)(3) entities (other than institutions of higher education).

20) Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also eligible under this opportunity.

21) Are public housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.

22) Are minority-serving institutions specifically mentioned?

Yes. The NOFO explicitly calls out additional eligible 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 (AANAPISIs).

23) Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are included in the eligible applicant categories.

24) Are regional organizations eligible?

Yes. Regional organizations are included as eligible applicants.

25) Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included in the eligible applicant categories.

26) Are non-U.S. (foreign) organizations eligible?

Yes. Non-U.S. (foreign) organizations are included as eligible applicants.

27) What is the maximum award amount listed for this opportunity?

The award ceiling is listed as $275,000.

28) When was this opportunity created?

The opportunity was created on 2024-11-04.

29) What is the original closing date?

The original closing date is 2025-07-01.

30) Which federal agency is offering this grant?

The grant is offered by the National Institutes of Health (NIH), specifically through the National Cancer Institute (NCI).

31) How is this opportunity categorized administratively?

It is described as a discretionary grant opportunity under NIH, with activity categories listed as Education and Health.

32) What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.393, 93.394, 93.395, 93.396, and 93.399.

33) What is the overall "fit" for an ideal project?

An ideal project is a bold, early-stage clinical and translational cancer idea that can produce feasibility data, preliminary evidence, or proof-of-concept results, and that has a plausible pathway to larger-scale development and clinical testing.