NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) | PAR 19 356

Opportunity Information: Apply for PAR 19 356

The NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) funding opportunity (PAR-19-356) is a National Institutes of Health grant designed to kick-start early-stage, high-impact cancer research ideas that are not yet ready for larger, more definitive funding mechanisms. It focuses on exploratory and developmental studies across the cancer research pipeline, with an emphasis on projects that test bold concepts, generate strong preliminary signals, and create new tools or approaches that can rapidly change what is possible in cancer research or care. The announcement explicitly supports work spanning cancer diagnosis, treatment, imaging, symptom and toxicity management, and prevention, and it welcomes projects that connect tightly to clinical translation, including studies that set the stage for first-in-human trials.

A major theme of the opportunity is enabling innovative, mechanism-driven work that can move the field forward even if it carries substantial scientific risk. That includes correlative studies tied to clinical trials (for example, biomarker discovery and validation efforts embedded in ongoing trials), as well as exploratory work that informs the development of novel therapeutics, symptom/toxicity interventions, and preventive agents. It also includes radiotherapy development activities and research on mechanism-based combinations, such as rational drug-drug or drug-radiation strategies grounded in tumor biology and resistance pathways. On the preclinical side, the FOA highlights the value of innovative studies that use new clinically relevant models and advanced imaging technologies, particularly when those approaches improve confidence that findings will translate into patients. In practical terms, NCI is signaling interest in projects that create new methods, platforms, models, or candidate interventions and quickly generate the kind of evidence needed to justify the next translational step.

This FOA uses the NIH R21 mechanism, which is specifically intended for early, conceptual projects rather than fully mature programs of research. R21 awards are often used to explore a new hypothesis, build or refine a novel technology, produce initial proof-of-concept data, or de-risk a creative approach that could later compete for larger awards or support clinical development. The FOA acknowledges that these projects may involve considerable risk, but it balances that by emphasizing potential payoff: breakthroughs in a specific cancer research area or the creation of novel techniques, agents, methodologies, models, or applications that can have an outsized impact on either preclinical or clinical cancer research.

The opportunity is labeled "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component, but they are not required to do so. This structure is meant to accommodate both translational preclinical work that aims to enable future trials and early clinical efforts where appropriate, as long as the project remains exploratory/developmental in scope and aligned with NCI priorities described in the announcement.

In terms of who can apply, eligibility is broad and includes many types of public and private organizations. Eligible applicants include state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The FOA also highlights 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and non-U.S. entities (foreign organizations). Taken together, this reflects an intent to encourage wide participation, including institutions serving underrepresented communities and organizations positioned to contribute unique patient populations, research resources, or translational expertise.

From the posted opportunity details, the sponsoring agency is the National Institutes of Health (with NCI as the relevant institute for this FOA), and the activity is categorized under education and health. The CFDA program numbers listed are 93.393, 93.394, 93.395, 93.396, and 93.399, reflecting multiple NCI program areas that can support cancer research. The listed award ceiling is $200,000, which is consistent with an exploratory R21-style budget scale intended to fund early proof-of-concept work rather than large multi-site efforts. The original closing date shown is August 24, 2020, and the creation date is August 28, 2019, indicating this specific posting reflects that application window and version of the announcement.

Overall, this grant opportunity is best viewed as an on-ramp for creative cancer research projects that are poised to open up new scientific directions or translational opportunities. It is aimed at investigators and teams who have a compelling new approach but need targeted support to test feasibility, establish preliminary evidence, develop enabling models or technologies, or generate the mechanistic rationale needed to advance toward larger studies or first-in-human evaluation.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "NCI Clinical and Translational Exploratory/Developmental Studies (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): 93.393, 93.394, 93.395, 93.396, 93.399.
• This funding opportunity was created on 2019-08-28.
• Applicants must submit their applications by 2020-08-24. (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.

Apply for PAR 19 356

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