Opportunity Information: Apply for RFA AR 13 004
Apply for RFA AR 13 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Outcomes Instrument Development Grant Program (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846 Arthritis, Musculoskeletal and Skin Diseases Research.
- This funding opportunity was created on Jul 5, 2012 and posted on Jul 5, 2012.
- Applicants must submit their applications by Nov 9, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- Eligible applicants include: City or township governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Public and State controlled institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses State governments.
- 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 not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIAMS Clinical Trial Outcomes Instrument Development Grant Program (U01) is a National Institutes of Health funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) focused on improving how clinical trials measure what matters. The central purpose is to support research that develops, refines, and evaluates clinical trial outcome measures and instruments that can better capture both the positive effects of treatments (efficacy and real-world effectiveness) and the negative or unintended effects (adverse impacts) for NIAMS-relevant diseases and injuries. In practice, this means the program is aimed at strengthening the tools used to judge whether therapies truly help patients, how much they help, and at what cost in terms of side effects or other harms.
A key emphasis of the announcement is on outcomes that are clinically relevant and patient-important. Projects are expected to produce measures that reflect meaningful changes in patients health, functioning, symptoms, and overall well-being, not just laboratory or narrowly defined surrogate indicators. The FOA encourages work on both new measures and existing measures that need better validation or modernization. It also highlights that applicants may propose analytic approaches tied to these instruments, as long as the end goal is a set of outcomes measures that can be credibly used in clinical trials and interpreted in ways that influence clinical decision-making.
Another major theme is generalizability and eventual uptake. NIAMS is not looking for instruments that only work in one small setting or for a single, highly specific study population unless there is a clear path to broader usefulness. The expectation is that the resulting measures could be further tested in existing or new clinical trials and have a realistic chance of gaining widespread acceptance and application. The announcement explicitly connects this to the full clinical lifecycle: better outcomes tools should support diagnosis, ongoing monitoring, assessment of treatment response, and potentially the evaluation of approaches aimed at cure. The long-term target is direct impact on patient care by making trial results more interpretable, comparable across studies, and relevant to real clinical choices.
This opportunity uses a cooperative agreement mechanism (U01), meaning NIAMS anticipates a more collaborative relationship than a standard research project grant, with substantial NIH involvement during the project. While the detailed governance and collaboration expectations would be spelled out in the full FOA, the mechanism generally signals that awardees should be prepared for coordination with NIAMS staff, milestone-driven progress, and a focus on deliverables that can be used by the broader research and clinical community.
From an administrative standpoint, the program is listed under Funding Opportunity Number RFA-AR-13-004 and CFDA 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). It was posted July 5, 2012, with an application due date of November 9, 2012, and it was later archived December 10, 2012. The estimated total funding available was $1,000,000, with an award ceiling of $150,000. No cost sharing or matching was required.
Eligibility was broad across U.S.-based organizations, including state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations other than small businesses, and small businesses, with additional categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, and certain regional organizations. Non-U.S. entities (foreign institutions) and non-U.S. components of U.S. organizations were not eligible to apply, although foreign components as defined by NIH policy were allowed.
Overall, this FOA is best understood as NIAMS investing in the measurement infrastructure of clinical research: creating and validating outcome instruments that are sensitive, credible, and meaningful to patients and clinicians, so that future NIAMS-related clinical trials can generate results that translate more directly into improved care.
Frequently Asked Questions (FAQs)
What is the NIAMS Clinical Trial Outcomes Instrument Development Grant Program (U01)?
It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to support research that develops, refines, and evaluates clinical trial outcome measures and instruments for NIAMS-relevant diseases and injuries.
What is the main purpose of this funding opportunity?
The central purpose is to improve how clinical trials measure what matters by supporting better outcome measures that can capture both beneficial effects of treatments (efficacy and real-world effectiveness) and negative or unintended effects (adverse impacts).
What kinds of outcomes are emphasized in this program?
The announcement emphasizes outcomes that are clinically relevant and patient-important. Projects are expected to produce measures that reflect meaningful changes in patients' health, functioning, symptoms, and overall well-being rather than relying only on laboratory measures or narrowly defined surrogate indicators.
Does the program support creating new instruments, improving existing instruments, or both?
Both. The FOA encourages work on new measures as well as existing measures that need stronger validation or modernization.
Are adverse impacts and harms part of what the instruments should measure?
Yes. A stated goal is to better capture not only positive treatment effects but also negative or unintended effects (adverse impacts) relevant to NIAMS diseases and injuries.
Can applicants propose analytic approaches as part of the project?
Yes. Applicants may propose analytic approaches tied to the instruments, as long as the end goal is a set of outcome measures that can be credibly used in clinical trials and interpreted in ways that influence clinical decision-making.
What does NIAMS mean by "clinically relevant and patient-important" outcomes?
Based on the announcement, this means outcomes that reflect meaningful changes in patients' real experiences and status (health, symptoms, functioning, well-being) rather than measures that are only surrogate indicators or limited to laboratory findings.
Is the program focused on tools that only apply to one narrow population or one study setting?
No. A major theme is generalizability and eventual uptake. NIAMS is not looking for instruments that only work in one small setting or for a single highly specific study population unless there is a clear path to broader usefulness.
What is meant by "generalizability and eventual uptake"?
It refers to NIAMS's expectation that the resulting outcome measures could be further tested in existing or new clinical trials and have a realistic chance of gaining widespread acceptance and use by the broader research and clinical community.
How are the resulting instruments expected to be used over the long term?
The announcement ties improved outcomes tools to the full clinical lifecycle, including diagnosis, ongoing monitoring, assessment of treatment response, and potentially evaluation of approaches aimed at cure. The long-term target is direct impact on patient care by making trial results more interpretable, comparable across studies, and relevant to real clinical choices.
What funding mechanism does this opportunity use?
This opportunity uses a cooperative agreement mechanism (U01).
What does a U01 cooperative agreement imply for the relationship with NIH/NIAMS?
It indicates NIAMS anticipates a more collaborative relationship than a standard research project grant, with substantial NIH involvement during the project. The description suggests awardees should be prepared for coordination with NIAMS staff, milestone-driven progress, and a focus on deliverables intended for broader community use.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA-AR-13-004.
What is the CFDA number associated with this program?
The CFDA number is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
When was this funding opportunity posted, and what was the application due date?
It was posted on July 5, 2012, and the application due date was November 9, 2012.
Is this funding opportunity still active?
No. It was later archived on December 10, 2012.
How much total funding was estimated to be available?
The estimated total funding available was $1,000,000.
What was the award ceiling for individual awards?
The award ceiling was $150,000.
Is cost sharing or matching required?
No. The announcement states that no cost sharing or matching was required.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations, including state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations other than small businesses, and small businesses. Additional eligible categories listed include HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, and certain regional organizations.
Are non-U.S. entities (foreign institutions) eligible to apply?
No. Non-U.S. entities (foreign institutions) and non-U.S. components of U.S. organizations were not eligible to apply.
Are foreign components allowed under this FOA?
Yes. While non-U.S. entities were not eligible to apply, foreign components as defined by NIH policy were allowed.
What kinds of diseases or conditions does NIAMS consider relevant for this opportunity?
The program is framed around NIAMS-relevant diseases and injuries, consistent with NIAMS's mission areas in arthritis, musculoskeletal, and skin diseases research.
What is the program trying to improve in clinical trials?
It aims to strengthen the tools used to judge whether therapies truly help patients, how much they help, and what the tradeoffs are in terms of side effects or other harms, so that trial results are more interpretable and relevant to clinical decision-making.
What is the expected output of funded projects?
Based on the description, funded projects are expected to produce clinical trial outcome measures and instruments that are developed, refined, and evaluated, with an emphasis on credibility, sensitivity, meaningful interpretation, and practical usability in clinical trials.
How does NIAMS connect this program to patient care?
The long-term goal is direct impact on patient care by enabling clinical trials to generate results that translate more clearly into improved care, including better comparability across studies and greater relevance to real clinical choices.
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