Atom | NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional)

Due Dates: February 13, 2025 | March 1, 2025 (AIDS) | June 12, 2025 | July 1, 2025 (AIDS)

Funding Amounts: Up to $275,000 direct costs over 2 years (no more than $200,000 in any single year); project period max 2 years.

Summary: Supports high-risk, early-stage exploratory and developmental research in cancer diagnosis, treatment, prevention, and related clinical/preclinical studies.

Key Information: Applications focused on basic cancer biology, late-stage clinical trials, or epidemiology are not eligible; clinical trial optional.

Description

This opportunity from the National Cancer Institute (NCI) supports innovative, hypothesis-driven exploratory and developmental research projects (R21 mechanism) in cancer. The focus is on preclinical and early phase clinical studies, correlative studies, and projects that could lead to breakthroughs in cancer diagnosis, treatment, prevention, imaging, symptom/toxicity management, and reduction of cancer disparities. The program encourages high-risk, high-reward research that may lead to the development of novel agents, methodologies, models, or applications with significant impact on cancer research or clinical practice.

Projects may include:

Early-phase clinical trials of new or repurposed agents, combinations, or interventions (including radiation).
Development and validation of predictive/prognostic biomarkers or imaging tools.
Preclinical studies using clinically relevant models (e.g., organoids, patient-derived xenografts).
Comparative oncology studies (including in dogs as models for human disease).
Research addressing cancer health disparities.

Note: Applications focused on basic cancer biology (e.g., studies of molecular mechanisms, pathways, or tumor microenvironment not directly tied to clinical/preclinical development), late-stage clinical trials, epidemiological, or behavioral intervention studies are not responsive and will not be reviewed.

Due Dates

February 13, 2025: New, renewal, resubmission, and revision applications
March 1, 2025: AIDS-related applications (new, renewal, resubmission, revision)
June 12, 2025: New, renewal, resubmission, and revision applications
July 1, 2025: AIDS-related applications (new, renewal, resubmission, revision)

All applications are due by 5:00 PM local time of the applicant organization.

Funding Amount

Maximum direct costs: $275,000 over a two-year project period
Annual limit: No more than $200,000 in direct costs in any single year
Project period: Up to 2 years
Number of awards: Dependent on NIH appropriations and number of meritorious applications

Eligibility

Eligible applicants include:

Public and private institutions of higher education (domestic and foreign)
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Native American tribal governments and organizations (federally recognized and other)
Faith-based and community-based organizations
Regional organizations
U.S. territories and possessions
Non-domestic (non-U.S.) entities and components of U.S. organizations

Individuals: Any qualified individual with the skills, knowledge, and resources to carry out the proposed research may apply as PI/PD.

Note: Applicant organizations may submit more than one application, provided each is scientifically distinct.

Application Process

Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required registrations: SAM, eRA Commons, Grants.gov (can take 6+ weeks; start early).
Application instructions: Follow the NIH SF424 (R&R) Application Guide and the full NOFO.
Clinical trial optional: Applications may propose a clinical trial, but it is not required.
Data Management and Sharing Plan: Required for all applications generating scientific data.
Page limits: As specified in the NIH Table of Page Limits.
Appendices: Only limited materials allowed; see application guide.

Additional Information

Scope: Projects must be directly related to the development of novel approaches for cancer treatment, diagnosis, prevention, symptom management, or reduction of cancer disparities.
Not responsive: Basic cancer biology, late-stage clinical trials, epidemiology, and behavioral intervention studies.
Clinical trial requirements: If proposing a clinical trial, follow all NIH clinical trial policies, including registration and reporting.
Foreign organizations: Eligible and may apply; must follow NIH policies for foreign applicants.
No cost sharing required.
Multiple applications: Allowed if scientifically distinct.

External Links

Contact Information

Topic/Area	Contact	Email	Phone
General Grants Info	NIH Grants Information	GrantsInfo@nih.gov	301-480-7075
Preclinical Studies	Morgan O'Hayre, Ph.D.	ohayrem@mail.nih.gov	240-276-7482
Clinical Studies	Anita Undale, MD, Ph.D.	anita.undale@nih.gov	240-276-5251
Prevention/Symptom Mgmt	Marjorie Perloff, MD	perloffm@mail.nih.gov	240-276-7097
Cancer Health Disparities	Tiffany Wallace, Ph.D.	wallaceti@mail.nih.gov	240-276-5114
Peer Review	Referral Officer, NCI	ncirefof@dea.nci.nih.gov	240-276-6390
Grants Management	Crystal Wolfrey	wolfreyc@mail.nih.gov	240-276-6277

For technical assistance with electronic submission:

eRA Service Desk | 301-402-7469 or 866-504-9552
Grants.gov Support | 800-518-4726

NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional)