Opportunity Information: Apply for PAR 22 216

The NCI Clinical and Translational Exploratory/Developmental Studies funding opportunity (R21 Clinical Trial Optional), listed as PAR-22-216, is a National Institutes of Health (NIH) grant program designed to spark early-stage, high-impact cancer research projects that are still in the exploratory or developmental phase. It focuses on ideas that are promising but not yet fully proven, where investigators may be testing new concepts, building early evidence, or developing a novel approach that could reshape how a cancer problem is studied or addressed. The core purpose is to move innovative cancer science forward more quickly by supporting projects that may carry meaningful risk but also have the potential to produce major breakthroughs or open entirely new directions for the field.

In terms of scientific scope, the FOA is broad but clearly centered on clinically relevant cancer research. It supports exploratory studies in cancer diagnosis, treatment, imaging, symptom management and toxicity, and prevention. A major emphasis is placed on correlative studies linked to clinical trials, meaning research that leverages clinical trial contexts to better understand mechanisms, biomarkers, response patterns, resistance, toxicity, or other clinically meaningful signals. It also supports early work tied to the development of novel cancer therapeutics, new agents aimed at preventing cancer, and interventions targeting symptoms or treatment-related toxicities. Radiotherapy development activities are specifically included, as are mechanism-driven combinations, where investigators explore rational combinations of therapies based on biology rather than trial-and-error pairing.

The opportunity also encourages innovative preclinical studies, especially those that strengthen the bridge between laboratory findings and real-world clinical testing. This includes using new clinically relevant models (for example, improved tumor models that better replicate human disease) and advanced imaging technologies that could improve how cancer is detected, measured, or monitored. Importantly, the FOA highlights projects that could reasonably lead to first-in-human clinical trials, even if the proposed R21 work itself is not a definitive clinical trial. Because the announcement is labeled “Clinical Trial Optional,” applicants can propose projects that include a clinical trial component if appropriate, but they are not required to do so. This flexibility makes the mechanism suitable for both translational projects preparing for clinical entry and early clinical explorations where a small, well-defined trial is justified.

As an R21 mechanism, the funding structure is meant for early, concept-forming research rather than large-scale validation. The R21 format is commonly used when the work is still at a stage where investigators need support to generate key feasibility data, establish proof-of-concept, develop or optimize a new method, or test a bold hypothesis. Reviewers generally understand that R21 projects may not have extensive preliminary data and may involve approaches that could fail, but they also expect a strong rationale, a clear innovation argument, and a plausible pathway from the proposed work to meaningful next steps (such as a larger R01, a clinical trial, or a translational package that enables regulatory progress).

From the administrative details provided, this is a discretionary grant program under NIH, with activity categories spanning education and health and tied to CFDA numbers 93.393, 93.394, 93.395, 93.396, and 93.399. The award ceiling listed is $275,000. The opportunity was created on July 14, 2022, and the original closing date shown is July 1, 2025. (Applicants would still want to confirm current submission windows and any updated due dates or policy changes on the official NIH funding page and in the active FOA.)

Eligibility is intentionally expansive and includes many types of applicants across academia, government, nonprofit, and industry. Eligible applicants listed include state, county, city, township, 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 and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant categories 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. entities (foreign organizations). This breadth signals an intent to attract diverse institutions and teams, including those embedded in communities or health systems where cancer burdens and care challenges may be especially pressing.

Overall, PAR-22-216 is best understood as an NCI-backed on-ramp for novel cancer research concepts that are clinically anchored and potentially transformative. It is designed to help investigators test new ideas in cancer diagnostics, therapeutics, imaging, radiotherapy, symptom/toxicity management, and prevention, including correlative work connected to clinical trials and translational preclinical research that can credibly set the stage for first-in-human studies. The program’s emphasis on innovation, mechanism-based thinking, and clinically relevant models and tools makes it particularly suited for teams aiming to convert cutting-edge biology or technology into a realistic path toward improved cancer outcomes.

  • 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 2022-07-14.
  • Applicants must submit their applications by 2025-07-01. (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 $275,000.00 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.
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FAQs: NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) - PAR-22-216

What is PAR-22-216?

PAR-22-216 is an NCI (National Cancer Institute) funding opportunity announcement (FOA) under the NIH that supports Clinical and Translational Exploratory/Developmental Studies using the R21 mechanism. It is designed to accelerate early-stage, high-impact cancer research ideas that are still exploratory or developmental.

What is the main purpose of this funding opportunity?

The purpose is to move innovative, clinically relevant cancer science forward faster by supporting promising ideas that may be higher-risk but could generate major breakthroughs or open new research directions. The FOA is meant to help investigators generate feasibility data, proof-of-concept evidence, or early development results that enable strong next steps.

What kinds of projects does this FOA support?

The scientific scope is broad but centered on clinically relevant cancer research. Supported areas include exploratory studies in cancer diagnosis, treatment, imaging, symptom management and toxicity, and prevention. The FOA also supports translational and preclinical work that strengthens the path from laboratory findings to clinical testing.

Does the FOA focus on research connected to clinical trials?

Yes. A major emphasis is placed on correlative studies linked to clinical trials. These are studies that use clinical trial contexts to learn more about mechanisms, biomarkers, response patterns, resistance, toxicity, and other clinically meaningful signals.

Are clinical trials required under this announcement?

No. This opportunity is labeled “Clinical Trial Optional,” meaning applicants may propose a project that includes a clinical trial component if appropriate, but a clinical trial is not required.

If clinical trials are optional, what types of clinical work might still fit?

The FOA is suitable for early clinical explorations where a small, well-defined trial is justified, as well as translational projects that prepare for clinical entry. It also highlights projects that could reasonably lead to first-in-human clinical trials, even if the R21 project itself is not a definitive clinical trial.

Does this funding support development of new cancer therapeutics?

Yes. The FOA supports early work tied to the development of novel cancer therapeutics, including development activities that could contribute to a path toward clinical testing.

Does the FOA support cancer prevention research?

Yes. It supports exploratory studies in cancer prevention, including early work related to developing new agents aimed at preventing cancer.

Are symptom management and toxicity-related projects within scope?

Yes. The FOA explicitly includes symptom management and toxicity, including interventions targeting symptoms or treatment-related toxicities.

Is radiotherapy research included?

Yes. Radiotherapy development activities are specifically included within the FOA’s scope.

Does the FOA encourage combination therapy research?

Yes. It includes mechanism-driven combinations, where investigators explore rational combinations of therapies based on biological reasoning rather than trial-and-error pairing.

What role do preclinical studies play in this FOA?

The FOA encourages innovative preclinical studies, particularly those that improve translation to real-world clinical testing. This includes work using new clinically relevant models (such as improved tumor models that better replicate human disease) and advanced imaging technologies.

Is imaging research eligible under this opportunity?

Yes. Imaging is explicitly within scope, including advanced imaging technologies that could improve how cancer is detected, measured, or monitored.

What stage of research is the R21 mechanism meant for?

R21 awards are meant for early, concept-forming research rather than large-scale validation. This includes projects aimed at generating key feasibility data, establishing proof-of-concept, developing or optimizing a new method, or testing a bold hypothesis that could lead to larger follow-on studies.

How much preliminary data is typically expected for an R21 under this FOA?

R21 projects are commonly used when there is not yet extensive preliminary data. Reviewers generally understand that exploratory/developmental projects may have limited early data and may carry meaningful risk, but they still expect a strong rationale, clear innovation, and a plausible path to impactful next steps.

What do reviewers generally look for in an R21 application like this?

Based on the description provided, reviewers generally expect: (1) a strong scientific and clinical rationale, (2) a clear argument for innovation and potential impact, and (3) a plausible pathway from the proposed work to meaningful next steps such as an R01, a clinical trial, or a translational package that supports regulatory progress.

What is the maximum award amount listed for this opportunity?

The listed award ceiling is $275,000.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH), with the National Cancer Institute (NCI) as the program focus for this cancer research opportunity.

What are the activity categories and CFDA numbers associated with this program?

This is a discretionary NIH grant program with activity categories spanning education and health. The CFDA numbers listed are 93.393, 93.394, 93.395, 93.396, and 93.399.

When was this opportunity created and when does it close?

The opportunity was created on July 14, 2022. The original closing date shown is July 1, 2025.

Should applicants rely solely on the closing date shown?

No. Applicants are advised to confirm current submission windows, due dates, and any policy updates on the official NIH funding page and within the active FOA, since dates and requirements can change over time.

Who is eligible to apply?

Eligibility is broad and includes many organizations across academia, government, nonprofit, and industry. Eligible applicants listed include: state, county, city, township, 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 and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. Additional eligible categories explicitly called out include Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.

Can federal agencies, regional organizations, or U.S. territories apply?

Yes. The FOA includes eligible federal agencies, regional organizations, and U.S. territories or possessions among eligible applicant types.

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

Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) as eligible applicants.

What makes this FOA a good fit for “high-risk, high-reward” ideas?

It is designed to support early-stage concepts that are promising but not yet fully proven. The program is intended to help teams test new concepts, build early evidence, or develop novel approaches that could reshape how a cancer problem is studied or addressed, even when the work involves meaningful scientific risk.

What types of next steps is this FOA intended to enable?

The FOA is structured to help investigators reach meaningful next steps, such as competing for a larger R01, moving toward a clinical trial, or assembling a translational package that helps advance a concept toward clinical or regulatory progress.

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