Opportunity Information: Apply for PAR 21 033
The National Institutes of Health, through the National Cancer Institute (NCI), is offering the grant opportunity titled "National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)" under Funding Opportunity Number PAR-21-033. This is a discretionary grant program using the R01 research project grant mechanism, and it is specifically designed to support investigator-initiated early phase clinical trials that align with the mission and priorities of NCI's Division of Cancer Treatment and Diagnosis (DCTD). The central aim is to move promising cancer-focused diagnostics and therapies into human testing in a structured, hypothesis-driven way, while generating the kinds of safety, feasibility, and early efficacy signals that can justify later-stage development.
Projects proposed under this FOA must include research that meets the NIH definition of a clinical trial, meaning the application needs to describe a prospective study in which human participants are assigned to an intervention to evaluate effects on health-related biomedical or behavioral outcomes. The FOA is focused on early phase studies only: Phase 0 (often exploratory, including first-in-human microdosing or pharmacodynamic assessments), Phase I (primarily assessing safety, dosing, and tolerability), and Phase II (typically expanding to examine preliminary efficacy and further characterize safety, sometimes with biomarker-driven or patient-selection strategies). The emphasis is on cancer-targeted diagnostic and therapeutic interventions, so proposals are expected to be clearly tied to cancer treatment and/or cancer diagnosis and to be directly relevant to DCTD priorities. Applicants are encouraged to review the DCTD website (https://dctd.cancer.gov/) to understand NCI's current program goals, research strategies, and priority areas, since the strongest applications usually demonstrate a clear line of sight between the proposed trial and DCTD's broader translational and clinical objectives.
A key limitation of the opportunity is that Phase III clinical trials are explicitly out of scope. Applications proposing Phase III trials in any cancer research area are not sought and will not be supported through this FOA. In practical terms, the FOA is meant to fund the earlier decision-making stages of clinical development, where the main deliverables are credible human data on safety, dosing, target engagement or mechanism, feasibility of delivery, and early signals of clinical activity or diagnostic performance, rather than definitive comparisons of outcomes at scale.
Eligibility is broad and includes many organization types across the public, private, nonprofit, and academic landscape. Eligible applicants include state, county, city or 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; Native American tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility reflects the reality that early phase cancer trials can be led by many different kinds of institutions, including academic medical centers, research institutes, consortia, community-based clinical networks, and global partners, provided they can meet NIH expectations for trial conduct, oversight, and reporting.
Administratively, the opportunity is categorized under Education and Health funding activity areas and is associated with CFDA numbers 93.393, 93.394, 93.395, and 93.399. The source information lists an original closing date of 2024-01-07 and a creation date of 2020-11-12. While the award ceiling and expected number of awards are not specified in the provided data, applicants should generally expect R01 budgets and timelines to be justified by the scope and complexity of the proposed clinical trial, including participant accrual, clinical site operations, investigational product or diagnostic development needs, data management, monitoring, regulatory compliance, and required safety oversight.
Overall, PAR-21-033 is aimed at supporting well-designed, investigator-driven Phase 0 to Phase II cancer clinical trials that can efficiently answer critical early development questions for novel cancer therapies and diagnostics, while staying tightly aligned with NCI DCTD priorities and NIH clinical trial requirements, and explicitly avoiding late-stage Phase III trial activity.Apply for PAR 21 033
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)" 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, 93.399.
- This funding opportunity was created on 2020-11-12.
- Applicants must submit their applications by 2024-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)."
What is the Funding Opportunity Number (FOA)?
The Funding Opportunity Number is PAR-21-033.
Which agency is offering this grant?
The National Institutes of Health (NIH), through the National Cancer Institute (NCI), is offering this grant opportunity.
Which NCI division is this opportunity aligned with?
This FOA is designed to support projects aligned with the mission and priorities of NCI's Division of Cancer Treatment and Diagnosis (DCTD).
What grant mechanism is used for this program?
This is a discretionary grant program using the R01 research project grant mechanism.
What is the main purpose of PAR-21-033?
The central aim is to move promising cancer-focused diagnostics and therapies into human testing in a structured, hypothesis-driven way, generating data on safety, feasibility, and early efficacy signals to support later-stage development decisions.
Does the proposed research have to be a clinical trial?
Yes. Applications must include research that meets the NIH definition of a clinical trial, and the FOA is explicitly labeled "Clinical Trial Required."
What does NIH mean by a "clinical trial" for this FOA?
The application must describe a prospective study in which human participants are assigned to an intervention to evaluate effects on health-related biomedical or behavioral outcomes.
Which clinical trial phases are supported under this FOA?
This FOA focuses on early phase studies only: Phase 0, Phase I, and Phase II.
What is considered Phase 0 in the context of this FOA?
Phase 0 is often exploratory and may include first-in-human microdosing studies or pharmacodynamic assessments.
What is considered Phase I in the context of this FOA?
Phase I trials primarily assess safety, dosing, and tolerability.
What is considered Phase II in the context of this FOA?
Phase II trials typically expand evaluation to examine preliminary efficacy while continuing to characterize safety, and may incorporate biomarker-driven approaches or patient-selection strategies.
Are Phase III clinical trials allowed under this FOA?
No. Phase III clinical trials are explicitly out of scope. Applications proposing Phase III trials in any cancer research area are not sought and will not be supported through this FOA.
What types of interventions does this FOA emphasize?
The FOA emphasizes cancer-targeted diagnostic and therapeutic interventions tied to cancer treatment and/or cancer diagnosis.
How important is alignment with DCTD priorities?
Alignment is a core expectation. The strongest applications are expected to demonstrate a clear line of sight between the proposed early phase trial and DCTD's broader translational and clinical objectives.
Where can applicants learn about DCTD goals and priority areas?
Applicants are encouraged to review the DCTD website at https://dctd.cancer.gov/ to understand current program goals, research strategies, and priority areas.
What types of outcomes or deliverables is this FOA trying to generate?
The FOA is intended to support early development decision-making by generating credible human data such as safety, dosing, feasibility of delivery, target engagement or mechanism, and early signals of clinical activity or diagnostic performance.
What is specifically not the goal of this FOA?
This FOA is not intended to fund definitive, large-scale outcome comparisons typical of Phase III trials.
Who is eligible to apply?
Eligibility is broad and includes many organization types across public, private, nonprofit, and academic sectors, including U.S. and non-U.S. entities (foreign organizations), as listed in the FOA description provided.
Are government entities eligible?
Yes. Eligible applicants include state, county, city or township, and special district governments, as well as eligible federal agencies.
Are higher education institutions eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are eligible.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments and Native American tribal organizations that are not federally recognized governments are included among eligible applicants.
Are nonprofits eligible?
Yes. Nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education) are eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are eligible, and small businesses are also listed as eligible applicants.
Are community-based or faith-based organizations eligible?
Yes. The FOA highlights faith-based or community-based organizations among the additional eligible categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are included among the highlighted eligible categories.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are listed as eligible.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and Tribally Controlled Colleges and Universities (TCCUs).
What are the funding activity areas associated with this opportunity?
The opportunity is categorized under Education and Health funding activity areas.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.393, 93.394, 93.395, and 93.399.
What is the listed original closing date?
The source information lists an original closing date of 2024-01-07.
What is the listed creation date?
The source information lists a creation date of 2020-11-12.
Is the award ceiling provided?
No. The award ceiling is not specified in the provided information.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided information.
What should applicants expect regarding budget and timeline?
While specific ceilings are not provided, budgets and timelines should be justified by the scope and complexity of the proposed early phase clinical trial, including items like participant accrual, clinical site operations, investigational product or diagnostic development needs, data management, monitoring, regulatory compliance, and required safety oversight.
What types of projects are best suited for this FOA?
Well-designed, investigator-initiated Phase 0 to Phase II cancer clinical trials that efficiently answer critical early development questions for novel cancer therapies and diagnostics, and that align tightly with NCI DCTD priorities and NIH clinical trial requirements.
Can a project focused on cancer diagnosis be appropriate, or does it have to be treatment?
Either can be appropriate. The FOA supports early phase clinical trials for cancer treatment and diagnosis, with an emphasis on cancer-targeted diagnostic and therapeutic interventions.
Browse more opportunities from the same category: Education, Health
Next opportunity: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)
Previous opportunity: NINDS Research Education Programs for Residents and Fellows in Neurological Disorders and Stroke (R25 - Clinical Trial Not Allowed)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 21 033
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 21 033) also looked into and applied for these:
| Funding Opportunity |
|---|
| Multi-Site Studies for System-Level Implementation of Substance Use Prevention and Treatment Services (R34 Clinical Trial Optional) Apply for PAR 21 023 Funding Number: PAR 21 023 Agency: National Institutes of Health Category: Education, Health Funding Amount: $225,000 |
| Multi-Site Studies for System-Level Implementation of Substance Use Prevention and Treatment Services (R01 Clinical Trial Optional) Apply for PAR 21 022 Funding Number: PAR 21 022 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Strengthening HIV Prevention Efforts for Women in the Southern U.S. (R34 Clinical Trial Optional) Apply for RFA MH 21 150 Funding Number: RFA MH 21 150 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Strengthening HIV Prevention Efforts for Women in the Southern U.S. (R01 Clinical Trial Optional) Apply for RFA MH 21 151 Funding Number: RFA MH 21 151 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Cancer Research Education Grants Program - Curriculum or Methods Development (R25 Clinical Trial Not Allowed) Apply for PAR 21 065 Funding Number: PAR 21 065 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Cancer Research Education Grants Program - Courses for Skills Development (R25 Clinical Trial Not Allowed) Apply for PAR 21 066 Funding Number: PAR 21 066 Agency: National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
| Cancer Research Education Grants Program - Research Experiences (R25 Clinical Trial Not Allowed) Apply for PAR 21 067 Funding Number: PAR 21 067 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Innovative Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R21 Clinical Trial Not Allowed) Apply for RFA CA 21 003 Funding Number: RFA CA 21 003 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R21 Clinical Trial Not Allowed) Apply for RFA CA 21 005 Funding Number: RFA CA 21 005 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advanced Development and Validation of Emerging Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) Apply for RFA CA 21 004 Funding Number: RFA CA 21 004 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) Apply for RFA CA 21 006 Funding Number: RFA CA 21 006 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (U54 Clinical Trial Optional) Apply for RFA CA 21 009 Funding Number: RFA CA 21 009 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revision Applications for Incorporation of Novel NCI- Supported Technology to Accelerate Cancer Research (U01 Clinical Trial Optional) Apply for RFA CA 21 008 Funding Number: RFA CA 21 008 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (P50 Clinical Trial Optional) Apply for RFA CA 21 012 Funding Number: RFA CA 21 012 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (R01 Clinical Trial Optional) Apply for RFA CA 21 007 Funding Number: RFA CA 21 007 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (P01 Clinical Trial Optional) Apply for RFA CA 21 011 Funding Number: RFA CA 21 011 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (U2C Clinical Trial Optional) Apply for RFA CA 21 010 Funding Number: RFA CA 21 010 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Small Business Transition Grant For Early Career Scientists (R42 Clinical Trial Not Allowed) Apply for RFA CA 21 001 Funding Number: RFA CA 21 001 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional) Apply for RFA CA 21 014 Funding Number: RFA CA 21 014 Agency: National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
| Cellular Cancer Biology Imaging Research (CCBIR) Program (U54, Clinical Trial Not Allowed) Apply for RFA CA 21 002 Funding Number: RFA CA 21 002 Agency: National Institutes of Health Category: Education, Health Funding Amount: $1,250,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 21 033", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.