Opportunity Information: Apply for RFA AR 14 008
Apply for RFA AR 14 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Outcome 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 Apr 23, 2013 and posted on Apr 23, 2013.
- Applicants must submit their applications by Feb 7, 2014. (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: Native American tribal governments (Federally recognized) Small businesses Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Private institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Outcome Instrument Development Grant Program (U01), listed as RFA-AR-14-008, is a National Institutes of Health funding opportunity that supports research focused on improving how clinical trials measure outcomes in diseases and injuries within the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The central purpose is to fund projects that either create new clinical trial outcome instruments or strengthen and validate existing ones, so that trials can more accurately capture both the benefits of therapies (including efficacy and real-world effectiveness) and their potential harms or adverse impacts. In practical terms, the opportunity targets the tools used to judge whether a treatment is working and whether it is safe, with an emphasis on outcome measures that are meaningful in clinical decision-making and reflect what matters to patients.
A key theme of the announcement is that outcome instruments should be clinically relevant and patient-important. That means NIAMS is looking for measures that go beyond narrow laboratory or surrogate endpoints when appropriate and instead help characterize outcomes that clinicians and patients care about, such as pain, physical function, fatigue, disease activity, quality of life, skin symptoms, mobility, or other domain-specific impacts depending on the condition. The FOA encourages development work that positions these instruments for broader use, including eventual testing in current or future clinical trials, with the longer-term goal that the measures become widely accepted and routinely applied in research and, ultimately, patient care. Another stated priority is generalizability: applicants are expected to aim for instruments that can be applied across settings, populations, and studies as much as possible, rather than tools so specialized that they cannot be adopted broadly.
This program uses the U01 mechanism, meaning awards are cooperative agreements rather than standard investigator-initiated grants. A cooperative agreement typically implies substantial scientific or programmatic involvement by NIH staff during the project, which often translates into closer coordination with NIAMS on milestones, study design considerations, or dissemination and harmonization strategies. The activity category is health, and the relevant CFDA listing is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research). There is no cost sharing or matching requirement noted for this opportunity.
In terms of funding parameters, the FOA estimated a total funding level of about $1,000,000, with an award ceiling of $150,000. The announcement was posted on April 23, 2013, and the application due date was February 7, 2014, with archiving on March 10, 2014. While those dates indicate the specific solicitation is historical, the content still provides a clear snapshot of NIAMS priorities around measurement science and the development of credible, broadly usable clinical outcome assessments.
Eligibility is fairly broad and includes many types of U.S.-based organizations. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including those with 501(c)(3) status and certain nonprofits without 501(c)(3) status), small businesses, for-profit organizations other than small businesses, and a range of government entities such as state, county, city or township governments, independent school districts, special district governments, and public housing authorities/Indian housing authorities. The eligibility section also explicitly includes various mission-focused institutions and community-based entities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, Asian American and Native American Pacific Islander-serving institutions (AANAPISIs), faith-based or community-based organizations, and eligible federal agencies. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply, though foreign components (as defined by NIH policy) are allowed, which typically means a U.S. applicant organization may include certain foreign activities or collaborators when justified and compliant with NIH rules.
Overall, this opportunity is aimed at strengthening the foundation of clinical trials in NIAMS-related conditions by making outcome measurement more rigorous, more patient-centered, and more comparable across studies. By supporting the development and evaluation of outcome instruments that can be adopted widely, the FOA’s intended impact is to improve the quality of evidence generated in trials and to make that evidence more directly useful for diagnosis, monitoring, treatment decisions, and ultimately better patient care.
FAQs: NIAMS Clinical Trial Outcome Instrument Development Grant Program (U01) - RFA-AR-14-008
What is the NIAMS Clinical Trial Outcome Instrument Development Grant Program (U01)?
This NIH funding opportunity (RFA-AR-14-008) supports research to improve how clinical trials measure outcomes for diseases and injuries within the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The focus is on building better tools to evaluate whether a therapy works and whether it causes harm.
What is the main goal of this funding opportunity?
The central purpose is to fund projects that either (1) create new clinical trial outcome instruments or (2) strengthen and validate existing instruments, so clinical trials can more accurately capture benefits (including efficacy and real-world effectiveness) and potential harms or adverse impacts.
What does NIAMS mean by an "outcome instrument" in this program?
In this context, an outcome instrument is a tool used in clinical trials to judge treatment effects and safety. It can be a measure intended to capture clinically meaningful changes, including what matters to patients and what clinicians use for decision-making.
What kinds of outcomes are considered clinically relevant and patient-important?
The announcement emphasizes outcomes that clinicians and patients care about, such as pain, physical function, fatigue, disease activity, quality of life, skin symptoms, mobility, and other condition-specific impacts. The intent is to prioritize measures that are meaningful in real clinical decision-making.
Does the program discourage narrow lab or surrogate endpoints?
The FOA stresses going beyond narrow laboratory or surrogate endpoints when appropriate, and instead developing or improving measures that better characterize patient-important and clinically meaningful outcomes.
Is the focus only on measuring treatment benefits?
No. The opportunity specifically highlights the need to capture both benefits (including efficacy and real-world effectiveness) and potential harms or adverse impacts, so trials can assess whether a treatment is working and whether it is safe.
What types of projects are encouraged: creating new instruments or validating existing ones?
Both. The FOA supports projects that develop entirely new clinical trial outcome instruments as well as projects that strengthen, refine, and validate existing instruments.
What is the long-term impact NIAMS is aiming for?
The longer-term goal is for supported measures to be positioned for broader use, including eventual testing in current or future clinical trials, and to become widely accepted and routinely applied in research and, ultimately, patient care.
How important is generalizability for proposed outcome instruments?
Generalizability is a stated priority. Applicants are expected to aim for instruments that can be applied across settings, populations, and studies as much as possible, rather than tools too specialized for broad adoption.
What funding mechanism is used (U01), and what does that imply?
This program uses the U01 mechanism, which is a cooperative agreement rather than a standard investigator-initiated grant. A cooperative agreement typically includes substantial scientific or programmatic involvement by NIH staff during the project, often requiring closer coordination with NIAMS on milestones, study design considerations, or dissemination and harmonization strategies.
What is the activity category and CFDA number listed for this opportunity?
The activity category is health. The relevant CFDA listing is 93.846 (Arthritis, Musculoskeletal and Skin Diseases Research).
Is there a cost sharing or matching requirement?
No cost sharing or matching requirement is noted for this opportunity.
How much funding is available and what is the award ceiling?
The FOA estimated a total funding level of about $1,000,000, with an award ceiling of $150,000.
When was this opportunity posted and when were applications due?
The announcement was posted on April 23, 2013. The application due date was February 7, 2014. The opportunity was archived on March 10, 2014.
Is this a current or historical funding opportunity?
The listed due date and archive date indicate this specific solicitation is historical. However, the description provides a clear snapshot of NIAMS priorities around measurement science and clinical outcome assessment development.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations, including public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain nonprofits without 501(c)(3) status); small businesses; for-profit organizations other than small businesses; and a range of government entities.
What government entities are included as eligible applicants?
Eligible government entities include state, county, city or township governments; independent school districts; special district governments; and public housing authorities/Indian housing authorities.
Are community-based or mission-focused institutions explicitly included?
Yes. The eligibility section explicitly includes institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, Asian American and Native American Pacific Islander-serving institutions (AANAPISIs), faith-based or community-based organizations, and eligible federal agencies.
Are foreign institutions eligible to apply?
No. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply.
Are foreign components allowed at all?
Yes. Foreign components (as defined by NIH policy) are allowed, which generally means a U.S. applicant organization may include certain foreign activities or collaborators when justified and consistent with NIH rules.
What diseases or conditions does this program target?
The program targets diseases and injuries within the NIAMS mission, which includes arthritis, musculoskeletal, and skin diseases and related research areas.
Why is this program important for clinical trials?
The opportunity aims to strengthen the foundation of clinical trials in NIAMS-related conditions by making outcome measurement more rigorous, more patient-centered, and more comparable across studies. By supporting widely adoptable instruments, the intended impact is improved evidence quality and greater usefulness of trial results for diagnosis, monitoring, and treatment decisions.
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