Opportunity Information: Apply for PAR 08 025
Apply for PAR 08 025
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Quick Trials for Novel Cancer Therapies and Prevention Exploratory Grants (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on Dec 5, 2008 and posted on Nov 19, 2007.
- Applicants must submit their applications by Multiple Receipt Dates See Link to Full Announcement for details.. (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 $250,000.00 in funding.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education.
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply.
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Opportunity Summary:
The NIH funding opportunity PAR-08-025, titled "Quick Trials for Novel Cancer Therapies and Prevention Exploratory Grants (R21)," is designed to speed up early, translational cancer research by supporting small, focused clinical studies that test promising new treatment or prevention ideas tied to clearly defined molecular targets. The main aim is to help investigators move novel anticancer agents, new therapeutic modalities, or prevention strategies into the clinic quickly, especially when there is a strong scientific rationale involving a specific target or pathway. The opportunity is framed around pilot and exploratory clinical trials rather than large, definitive studies, with the expectation that these early results can justify and shape larger follow-on trials or more comprehensive research programs.
A central feature of this announcement is its emphasis on "quick trials" and accelerated review. Applicants are expected to include the full clinical protocol in the application Appendix, which is intended to help peer reviewers evaluate the clinical plan efficiently and to enable NIH to move from application receipt to award issuance on an expedited timeline, with a stated goal of making new awards within about six months after the application is received. The practical takeaway is that this FOA is built for time-sensitive, translational opportunities where moving rapidly from concept to human testing is important, and where a streamlined submission can support faster decision-making.
The FOA invites pilot clinical trials that may fall into Phase 0, Phase I, Phase II, or other early-stage trial formats appropriate for exploration and signal-seeking. Proposed studies can evaluate a single agent or modality, or combinations of agents/modalities, as long as the strategy is anchored to a defined molecular target and the trial is structured to explore that biology in a clinically meaningful way. Beyond the interventional component, the announcement explicitly allows and encourages patient monitoring and laboratory correlative studies that are connected to the trial, such as biomarker measurements, pharmacodynamic readouts, or other translational endpoints that help interpret mechanism of action, target engagement, or early indicators of response.
The scope is intentionally broad in terms of the types of interventions that can be studied. In addition to conventional drug or biologic development approaches, the FOA encourages applications that explore complementary and alternative approaches for cancer prevention and/or treatment, as long as they are framed with appropriate scientific rigor and tied to testable hypotheses. It also notes that trials may address AIDS-associated malignancies and cancer-related nutritional interventions, signaling NIH interest in supporting clinical exploration in these related and sometimes underserved areas of oncology and prevention research.
This opportunity uses the NIH R21 exploratory/developmental grant mechanism, which is meant for early, high-impact ideas that may be preliminary or proof-of-concept in nature. The R21 structure is generally used when the goal is to generate key feasibility, safety, biologic, or early efficacy signals rather than to conduct a fully powered, definitive clinical trial. The FOA also points applicants to a related R01-based announcement (PA-07-356) for more fully developed clinical therapeutic or preventive trials that are supported by stronger preliminary data and are ready for a larger research project framework. In other words, PAR-08-025 is positioned as a launchpad for early clinical translation, while the companion R01 path is better suited to more mature programs.
In terms of funding details, the award ceiling is listed as $250,000, and there is no cost-sharing or matching requirement. The number of awards is not predetermined and depends on the availability of NIH funds and the volume and quality of applications received, meaning competition and actual award counts can vary across receipt cycles. The opportunity is categorized as discretionary and is administered by the National Institutes of Health, with activity aligned to multiple cancer-related CFDA program areas: 93.393 (Cancer Cause and Prevention Research), 93.394 (Cancer Detection and Diagnosis Research), and 93.395 (Cancer Treatment Research).
Eligibility is broad and includes many common research-performing organizations: nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, small businesses, other for-profit organizations, and state governments. The announcement also clarifies that foreign institutions are eligible to apply and that eligible federal agencies may apply as well, which expands participation beyond the typical domestic academic and nonprofit landscape.
Administratively, the FOA was posted on November 19, 2007, with multiple receipt dates (rather than a single deadline), and it was later archived on December 10, 2010. Even though the program itself is archived, the structure and intent are a useful example of how NIH sometimes uses R21 mechanisms to accelerate early clinical translation around molecularly targeted cancer therapies and prevention strategies, particularly when paired with protocol-ready submissions that support rapid peer review.
FAQs: NIH PAR-08-025 - Quick Trials for Novel Cancer Therapies and Prevention Exploratory Grants (R21)
What is PAR-08-025?
PAR-08-025 is an NIH funding opportunity titled "Quick Trials for Novel Cancer Therapies and Prevention Exploratory Grants (R21)." It was designed to speed up early, translational cancer research by supporting small, focused clinical studies that test promising new treatment or prevention concepts tied to clearly defined molecular targets.
What is the main purpose of this funding opportunity?
The main goal is to move novel anticancer agents, new therapeutic modalities, or prevention strategies into the clinic quickly when there is a strong scientific rationale involving a specific molecular target or pathway. The expectation is that early clinical findings can justify and shape larger follow-on trials or broader research programs.
What does NIH mean by "quick trials" in this announcement?
"Quick trials" refers to pilot and exploratory clinical trials intended to move rapidly from concept to early testing in humans, rather than large, definitive studies. A key operational feature is the requirement to include the full clinical protocol in the application Appendix to streamline peer review and support faster NIH decision-making.
Is there an accelerated timeline for review and award?
Yes. The announcement describes accelerated review and an expedited path from application receipt to award issuance, with a stated goal of making new awards within about six months after an application is received.
What type of grant mechanism is used?
This opportunity uses the NIH R21 exploratory/developmental grant mechanism, which is commonly used for early, high-impact ideas that may be preliminary or proof-of-concept in nature.
What kinds of clinical trials are within scope?
The FOA invites pilot clinical trials that may fall into Phase 0, Phase I, Phase II, or other early-stage trial formats appropriate for exploration and signal-seeking.
Are large, definitive clinical trials supported under this opportunity?
The announcement is framed around pilot and exploratory trials rather than large, definitive studies. It focuses on generating early feasibility, safety, biologic, or early efficacy signals that can inform subsequent larger trials.
What kinds of interventions can be studied?
The scope is broad. Proposed studies can evaluate a single agent or modality, or combinations of agents/modalities, as long as the strategy is anchored to a defined molecular target and the trial explores that biology in a clinically meaningful way.
Does the intervention need to be tied to a specific molecular target?
Yes. A central theme is that the proposed therapy or prevention strategy should be linked to a clearly defined molecular target or pathway, with a strong scientific rationale for testing that target in a clinical setting.
Are combination approaches allowed?
Yes. Trials may evaluate a single agent or modality or combinations of agents/modalities, provided the approach is tied to a defined molecular target and structured to explore the underlying biology.
Can applications include patient monitoring and laboratory correlative studies?
Yes. The announcement explicitly allows and encourages patient monitoring and laboratory correlative studies connected to the trial, such as biomarker measurements, pharmacodynamic readouts, and other translational endpoints that help interpret mechanism of action, target engagement, or early indicators of response.
Are biomarker or pharmacodynamic endpoints appropriate under this FOA?
Yes. Biomarker measurements and pharmacodynamic readouts are specifically mentioned as examples of appropriate correlative work that supports interpretation of target engagement and early response signals.
Does this FOA support cancer prevention studies as well as treatment studies?
Yes. It supports exploratory clinical studies for both novel cancer therapies and prevention strategies, particularly those connected to defined molecular targets.
Are complementary and alternative approaches allowed?
Yes. The FOA encourages applications exploring complementary and alternative approaches for cancer prevention and/or treatment, as long as they are presented with scientific rigor and tied to testable hypotheses.
Can studies address AIDS-associated malignancies?
Yes. The announcement notes that trials may address AIDS-associated malignancies.
Are cancer-related nutritional interventions within scope?
Yes. The FOA signals interest in cancer-related nutritional interventions as part of its broader clinical exploration in oncology and prevention research.
What is the maximum award amount under this opportunity?
The award ceiling is listed as $250,000.
Is cost-sharing or matching required?
No. The announcement states there is no cost-sharing or matching requirement.
How many awards will NIH make?
The number of awards is not predetermined. It depends on the availability of NIH funds and the volume and quality of applications received, so award counts may vary across receipt cycles.
Who administers this funding opportunity?
This opportunity is administered by the National Institutes of Health (NIH).
Which program areas (CFDA numbers) are associated with this FOA?
The activity is aligned to multiple cancer-related CFDA program areas: 93.393 (Cancer Cause and Prevention Research), 93.394 (Cancer Detection and Diagnosis Research), and 93.395 (Cancer Treatment Research).
What types of organizations are eligible to apply?
Eligibility is broad and includes nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, small businesses, other for-profit organizations, and state governments.
Are foreign institutions eligible?
Yes. The announcement clarifies that foreign institutions are eligible to apply.
Can federal agencies apply?
Yes. The FOA states that eligible federal agencies may apply.
Were there multiple receipt dates or a single deadline?
The FOA had multiple receipt dates rather than a single deadline.
When was this FOA posted?
It was posted on November 19, 2007.
Is this funding opportunity still active?
No. The announcement was archived on December 10, 2010.
If PAR-08-025 is archived, why is it still useful to review?
Even though it is archived, it provides a clear example of how NIH can use an R21 mechanism to accelerate early clinical translation around molecularly targeted cancer therapies and prevention strategies, including the use of protocol-ready submissions to support rapid peer review.
Is there a related NIH opportunity for more developed or larger clinical trials?
Yes. The FOA points applicants to a related R01-based announcement (PA-07-356) for more fully developed clinical therapeutic or preventive trials supported by stronger preliminary data and suited to a larger research project framework.
How does PAR-08-025 differ from the related R01 path mentioned?
PAR-08-025 (R21) is positioned as a launchpad for early clinical translation, aiming to generate key early signals in small, focused trials. The related R01 path is positioned for more mature programs with stronger preliminary data and a broader, more comprehensive trial or research plan.
What is a key application requirement highlighted in this FOA?
A central administrative feature is that applicants are expected to include the full clinical protocol in the application Appendix so peer reviewers can evaluate the clinical plan efficiently and NIH can move toward an expedited award timeline.
What kinds of outcomes or deliverables is NIH expecting from these "quick trials"?
The FOA emphasizes early results that can justify and shape larger follow-on trials or more comprehensive research programs, including translational findings that clarify mechanism of action, target engagement, and early indicators of response.
Is this opportunity focused only on treatment, or also on prevention?
It is focused on both. The title and description emphasize novel cancer therapies and cancer prevention strategies, with a consistent focus on molecularly defined targets and early clinical testing.
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Previous opportunity: Support of Competitive Research (SCORE) Research Continuance Award (SC3)
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 08 025) also looked into and applied for these:
| Funding Opportunity |
|---|
| Research on Co Morbid Mental and Other Physical Disorders (R01) Apply for PA 08 029 Funding Number: PA 08 029 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Exfoliated Cells, Bioactive Food Components, and Cancer (R01) Apply for PA 08 030 Funding Number: PA 08 030 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Exfoliated Cells, Bioactive Food Components, and Cancer (R21) Apply for PA 08 031 Funding Number: PA 08 031 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Molecular Approaches to Diet and Pancreatic Cancer Prevention (R01) Apply for PA 08 032 Funding Number: PA 08 032 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Thyroid in Aging (R01) Apply for PA 08 037 Funding Number: PA 08 037 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Thyroid in Aging (R21) Apply for PA 08 038 Funding Number: PA 08 038 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Thyroid in Aging (R03) Apply for PA 08 039 Funding Number: PA 08 039 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Outcomes, Cost Effectiveness and the Decision Making Process to Use Complementary and Alternative Medicine (R01) Apply for PAR 08 045 Funding Number: PAR 08 045 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Understanding and Preventing Brain Tumor Dispersal (R01) Apply for PAS 08 048 Funding Number: PAS 08 048 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Understanding and Preventing Brain Tumor Dispersal (R21) Apply for PAS 08 049 Funding Number: PAS 08 049 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Long Acting, Sustainable Therapies for Opiate Addiction (R01) Apply for PAS 08 061 Funding Number: PAS 08 061 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Alzheimer s Disease Pilot Clinical Trials (R01) Apply for PAR 08 062 Funding Number: PAR 08 062 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Decision Making in Cancer Single Event Decisions (R01) Apply for PA 08 063 Funding Number: PA 08 063 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Decision Making in Cancer Single Event Decisions (R21) Apply for PA 08 064 Funding Number: PA 08 064 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research on the Economics of Diet, Activity and Energy Balance (R21) Apply for PA 08 077 Funding Number: PA 08 077 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| NLM Express Research Grants in Biomedical Informatics (R01) Apply for PAR 08 080 Funding Number: PAR 08 080 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| The Effect of Racial and Ethnic Discrimination/Bias on Health Care Delivery (R21) Apply for PA 08 084 Funding Number: PA 08 084 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| The Effect of Racial and Ethnic Discrimination/Bias on Health Care Delivery (R03) Apply for PA 08 085 Funding Number: PA 08 085 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Functional Links between the Immune System, Brain Function and Behavior (R01) Apply for PA 08 097 Funding Number: PA 08 097 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Functional Links between the Immune System, Brain Function and Behavior (R21) Apply for PA 08 098 Funding Number: PA 08 098 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
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