Opportunity Information: Apply for PA 12 013
Apply for PA 12 013
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi Site Cancer Trials (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on Nov 16, 2011 and posted on Nov 16, 2011.
- Applicants must submit their applications by Jan 7, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Private institutions of higher education County governments Independent school districts Public housing authorities/Indian housing authorities Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education State governments For profit organizations other than small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The grant opportunity titled "Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi Site Cancer Trials (R01)" (Funding Opportunity Number PA 12 013) is an NIH National Cancer Institute (NCI) Research Project Grant (R01) program focused on taking promising molecular diagnostics that already have preliminary supporting evidence and putting them through the kind of rigorous validation needed for real clinical use. The core aim is to confirm clinical utility, meaning the test should help doctors make better decisions for cancer patients by improving prognosis estimates or by predicting how a patient will respond to a given therapy, including the likelihood of treatment benefit or the risk of toxicity. Rather than funding early stage discovery of new biomarkers, this FOA is designed for the next step: moving candidate biomarkers from initial correlative findings into validated diagnostics that can be credibly used within clinical trials and, ultimately, clinical practice.
A defining feature of this FOA is its emphasis on using tumor specimens that are directly tied to well documented treatment and outcome data, particularly specimens collected in the context of multi site cancer clinical trials. This matters because it allows researchers to evaluate a diagnostic in a real world setting where treatment regimens, patient follow up, and clinical endpoints are clearly captured, and where the patient populations are typically more diverse than single institution studies. The program is co sponsored by NCI's Cancer Diagnosis Program (CDP) and Cancer Therapy Evaluation Program (CTEP), reflecting the intent to bridge diagnostic development and therapeutic evaluation. In practical terms, applicants are expected to show how a candidate molecular test can be analytically and clinically assessed using trial linked biospecimens, and how the results would be positioned to support future use in clinical trials to establish or strengthen the marker's clinical validity.
The scientific scope centers on molecular diagnostics that can stratify patients by risk (prognosis), predict response or resistance to a therapy (predictive biomarkers), or forecast adverse effects (toxicity prediction). Projects supported under this announcement are meant to improve clinical decision making, so a strong application would generally articulate a clear clinical context of use: which patients, which cancer type, which treatment setting, what decision the test will influence, and what outcome improvement would be expected if clinicians had the test results. Because the FOA is not meant for discovery, it is best suited for teams that already have a candidate marker or test with prior evidence and are ready to perform robust validation work using existing trial resources and carefully defined endpoints.
From an administrative standpoint, this is a discretionary grant using the R01 mechanism within NIH's health focused funding activities, with the relevant CFDA numbers listed as 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research). There is no cost sharing or matching requirement. The FOA was posted and created on November 16, 2011, with an original and current closing date of January 7, 2015, and it was archived on February 7, 2015. While the opportunity is no longer open, the summary remains useful as a template for understanding NCI's expectations for biomarker validation studies tied to clinical trials.
Eligibility is broad and includes many types of domestic U.S. organizations such as public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non 501(c)(3) entities), small businesses, and various units of government (state, county, city/township, special district), as well as independent school districts and public or Indian housing authorities. It also explicitly allows applications from tribal governments and tribal organizations, and highlights additional eligible applicants such as HBCUs, Hispanic serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith based or community based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Importantly, foreign institutions and non U.S. entities are eligible to apply, and foreign components are allowed under NIH policy, which can be relevant for international trial networks or specimen resources.
The sponsoring agency is the National Institutes of Health, specifically the National Cancer Institute, and the full announcement was made available through the NIH Grants Guide at the provided link. Contact support in the source text is directed to the NIH Office of Extramural Research webmaster for access or linking issues. Overall, the FOA targets a very specific translational gap in cancer research: turning biomarkers that look promising on paper into clinically dependable molecular diagnostics, validated against real treatment and outcome data from multi site cancer trials, with the explicit goal of making cancer care decisions more precise and evidence based.
Frequently Asked Questions (FAQs)
1) What is the title of this grant opportunity?
The opportunity is titled "Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi Site Cancer Trials (R01)."
2) What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA 12 013.
3) Which agency sponsors this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH), specifically the National Cancer Institute (NCI).
4) What grant mechanism is used?
This opportunity uses the NIH Research Project Grant (R01) mechanism.
5) What is the main purpose of this FOA?
The main purpose is to rigorously validate promising molecular diagnostics that already have preliminary supporting evidence, so they can credibly be used for real clinical decision making and within clinical trials.
6) Does this FOA fund discovery of new biomarkers?
No. The FOA is intended for validation of candidate biomarkers/diagnostics that already have prior evidence, rather than early stage discovery.
7) What does "clinical utility" mean in the context of this FOA?
Clinical utility means the test should help doctors make better decisions for cancer patients, such as improving prognosis estimates or predicting response to therapy, including likelihood of benefit or risk of toxicity.
8) What types of molecular diagnostics are within the scientific scope?
The FOA focuses on molecular diagnostics that can:
- Stratify patients by risk (prognostic biomarkers)
- Predict response or resistance to a therapy (predictive biomarkers)
- Forecast adverse effects (toxicity prediction)
9) What specimens are emphasized for validation studies under this FOA?
A defining emphasis is on tumor specimens that are directly tied to well documented treatment and outcome data, particularly specimens collected in the context of multi site cancer clinical trials.
10) Why does the FOA emphasize specimens from multi site cancer trials?
Because trial linked specimens come with clearly captured treatment regimens, follow up, and clinical endpoints, and multi site trials often include more diverse patient populations than single institution studies. This supports evaluation of a diagnostic in a more real world setting.
11) Which NCI programs co sponsor this FOA?
The FOA is co sponsored by NCI's Cancer Diagnosis Program (CDP) and Cancer Therapy Evaluation Program (CTEP), reflecting an intent to bridge diagnostic development and therapeutic evaluation.
12) What is NCI looking for in terms of how applicants frame their project?
Applicants are expected to show how a candidate molecular test can be analytically and clinically assessed using trial linked biospecimens, and how results would be positioned to support future use in clinical trials to establish or strengthen clinical validity.
13) What is meant by having a "clear clinical context of use"?
A strong application would typically describe the clinical situation the test is intended for, such as which patients, which cancer type, which treatment setting, what decision the test will influence, and what improvement in outcomes or decision quality is expected if clinicians have the test results.
14) Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
15) What type of grant is this described as administratively?
It is described as a discretionary grant using the R01 mechanism within NIH health focused funding activities.
16) What CFDA numbers are associated with this FOA?
The CFDA numbers listed are:
- 93.394 (Cancer Detection and Diagnosis Research)
- 93.395 (Cancer Treatment Research)
17) When was the FOA posted/created?
The FOA was posted and created on November 16, 2011.
18) What was the closing date for this opportunity?
The original and current closing date listed is January 7, 2015.
19) Is this grant opportunity still open?
No. It is no longer open; it was archived on February 7, 2015.
20) Who is eligible to apply?
Eligibility is broad and includes many types of domestic U.S. organizations, including public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non 501(c)(3) entities), small businesses, and various units of government (state, county, city/township, special district), as well as independent school districts and public or Indian housing authorities.
21) Are tribal governments and tribal organizations eligible?
Yes. The FOA explicitly allows applications from tribal governments and tribal organizations.
22) Are minority serving institutions and community based organizations included in the eligible applicant types?
Yes. The FOA highlights additional eligible applicants such as HBCUs, Hispanic serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith based or community based organizations, regional organizations, and U.S. territories or possessions.
23) Are foreign institutions or non U.S. entities allowed to apply?
Yes. Foreign institutions and non U.S. entities are eligible to apply, and foreign components are allowed under NIH policy.
24) Where was the full announcement made available?
The full announcement was made available through the NIH Grants Guide (via the link referenced in the source description).
25) Who is listed as the contact for access or linking issues?
Contact support in the source text is directed to the NIH Office of Extramural Research webmaster for access or linking issues.
26) What translational gap is this FOA trying to address?
It targets the gap between promising correlative biomarker findings and clinically dependable molecular diagnostics, by requiring rigorous validation against real treatment and outcome data from multi site cancer trials, with the goal of improving evidence based cancer care decisions.
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Applicants also applied for:
Applicants who have applied for this opportunity (PA 12 013) also looked into and applied for these:
| Funding Opportunity |
|---|
| Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi Site Cancer Trials (R21) Apply for PA 12 014 Funding Number: PA 12 014 Agency: National Institutes of Health Category: Education Health Funding Amount: $275,000 |
| Shared Instrumentation Grant Program (S10) Apply for PAR 12 017 Funding Number: PAR 12 017 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Midcareer Investigator Award in Mouse Pathobiology and Comprehensive Phenotyping Research (K26) Apply for PAR 12 021 Funding Number: PAR 12 021 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Practical Interventions to Improve Medication Adherence in Primary Care (R21) Apply for PA 12 023 Funding Number: PA 12 023 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Lasker Clinical Research Scholars Program (Si2) Apply for RFA OD 12 001 Funding Number: RFA OD 12 001 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Application of Genomic Advances to Wound Repair (R21) Apply for RFA NR 12 003 Funding Number: RFA NR 12 003 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Application of Genomic Advances to Wound Repair (R01) Apply for RFA NR 12 002 Funding Number: RFA NR 12 002 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| Behavioral Interventions to Address Multiple Chronic Health Conditions in Primary Care (R01) Apply for PA 12 024 Funding Number: PA 12 024 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Small Grants Program for Cancer Epidemiology (R03) Apply for PAR 12 039 Funding Number: PAR 12 039 Agency: National Institutes of Health Category: Education Health Funding Amount: $50,000 |
| Research to Advance Vaccine Safety (R01) Apply for PA 12 037 Funding Number: PA 12 037 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research to Advance Vaccine Safety (R21) Apply for PA 12 038 Funding Number: PA 12 038 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| International Research Collaboration on Drug Abuse and Addiction Research (R01) Apply for PA 12 040 Funding Number: PA 12 040 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| International Research Collaboration on Drug Abuse and Addiction Research (R21) Apply for PA 12 041 Funding Number: PA 12 041 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| International Research Collaboration on Drug Abuse and Addiction Research (R03) Apply for PA 12 042 Funding Number: PA 12 042 Agency: National Institutes of Health Category: Education Health Funding Amount: $50,000 |
| Limited Competition Competitive Revision for Technology Development within Biomedical Technology Research Centers (P41) Apply for PAR 12 046 Funding Number: PAR 12 046 Agency: National Institutes of Health Category: Education Health Funding Amount: $250,000 |
| Cancer Education Grants Program (R25) Apply for PAR 12 049 Funding Number: PAR 12 049 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Palliative Care and End of Life in People Living with HIV/AIDS(R01) Apply for RFA NR 12 004 Funding Number: RFA NR 12 004 Agency: National Institutes of Health Category: Education Health Funding Amount: $300,000 |
| Palliative Care and End of Life in People Living with HIV/AIDS (R21) Apply for RFA NR 12 005 Funding Number: RFA NR 12 005 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Limited Competition Comprehensive Partnerships to Advance Cancer Health Equity (CPACHE) (U54) Apply for PAR 12 055 Funding Number: PAR 12 055 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Limited Competition The Medical Education Partnership Initiative Linked Awards (MEPI) (R25) Apply for RFA TW 11 004 Funding Number: RFA TW 11 004 Agency: National Institutes of Health Category: Education Health Funding Amount: $250,000 |
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