Atom | Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional)

Funder: National Institutes of Health

Funding Amounts: Up to $225,000/year; max $450,000 direct costs over 3 years (no pilot trial) or $600,000 over 3 years (with pilot/feasibility trial); 3-year project period

Summary: Supports planning activities and feasibility studies to optimize the design and implementation of future cancer prevention and control clinical trials.

Key Information: Preliminary efficacy/effectiveness data for the intervention are required; non-domestic (foreign) organizations are eligible.

Description

This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds planning activities and preparatory studies to address critical gaps in the design and implementation of future multi-center Phase II or later phase clinical trials in cancer prevention and control. The grant is intended to help investigators collect feasibility data, refine study protocols, test recruitment and retention strategies, and address operational or statistical challenges before launching a full-scale trial. The ultimate goal is to improve the rigor, feasibility, and cost-effectiveness of future cancer clinical trials.

Due Dates

Standard application cycles: June 25, October 25, and February 25 annually through October 25, 2027.
Letter of Intent: 30 days prior to the application due date (optional but encouraged).

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

Funding Amount

Without pilot/feasibility clinical trial: Up to $225,000 in direct costs per year, not to exceed $450,000 over 3 years.
With pilot/feasibility clinical trial: Up to $225,000 in direct costs per year, not to exceed $600,000 over 3 years.
Project period: Maximum of 3 years.
Indirect costs: As per NIH policy and institutional rates.

The number of awards is contingent on NIH appropriations and the submission of a sufficient number of meritorious applications.

Eligibility

Eligible organizations:
- Higher education institutions (public and private)
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Tribal governments and organizations (federally recognized and other)
- Independent school districts
- Public housing authorities/Indian housing authorities
- Faith-based and community-based organizations
- Regional organizations
- Non-domestic (non-U.S.) entities (foreign organizations)
- U.S. territories and possessions
- Eligible agencies of the federal government
Principal Investigator (PI): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research.
Multiple applications: Allowed if each application is scientifically distinct.
Non-domestic (foreign) organizations: Eligible to apply and may include foreign components.

Application Process

Submission platforms: NIH ASSIST, Grants.gov Workspace, or institutional system-to-system solutions.
Required registrations: SAM, eRA Commons, Grants.gov, and (for foreign organizations) NCAGE code.
Application components: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
Key required attachments:
- Milestone Plan (max 2 pages)
- Future Clinical Trial Description (max 3 pages)
- Research Strategy (must address both planning activities and the future trial)
- Letters of Support
- Data Management and Sharing Plan (required for all applications)
Appendix: Only blank questionnaires or surveys are allowed; no publications or other materials.
Human Subjects: If applicable, complete the PHS Human Subjects and Clinical Trials Information form, including a detailed recruitment and retention plan and study timeline.
Budget: Use the R&R Budget Form (foreign organizations must use detailed budget).

Additional Information

Scope of Supported Activities

Refinement of study population, intervention, outcomes, or endpoints
Feasibility and pilot studies (if essential)
Recruitment and retention strategy development
Adaptation and validation of instruments or interventions for new populations
Identification of appropriate control/comparison groups
Statistical planning and modeling
Standardization of interventions or outcomes across sites
Assessment of intervention acceptability and adherence
Development and testing of training tools and fidelity measures

Non-Responsive Applications

Applications will not be reviewed if they:

Are first-in-human studies
Only propose protocol writing, infrastructure development, or implementation of an already fully designed trial
Are purely mechanistic or include animal studies
Lack a milestone plan or future clinical trial description
Propose an intervention without preliminary efficacy/effectiveness data

Review Criteria

Applications are evaluated for:

Significance and innovation
Rigor and feasibility of the planning approach
Expertise and resources of the team and environment
Appropriateness of the milestone plan and study timeline
Adequacy of plans for inclusion of women, minorities, and individuals across the lifespan

External Links

Contact Information

Topic/Area	Contact	Email	Phone
Cancer prevention, early detection, screening, symptom management	Goli Samimi, Ph.D., M.P.H. (NCI)	goli.samimi@nih.gov	240-276-6582
Cancer control and population sciences, cancer care delivery	Stephanie Land, Ph.D. (NCI)	stephanie.land@nih.gov	240-276-6946
Peer review	NCI Referral Officer	ncirefof@dea.nci.nih.gov	240-276-6390
Grants management	Crystal Wolfrey (NCI)	wolfreyc@mail.nih.gov	240-276-6277
General grants info	NIH Grants Info	GrantsInfo@nih.gov	301-480-7075
Application system help	eRA Service Desk	https://www.era.nih.gov/need-help	301-402-7469 / 866-504-9552