Opportunity Information: Apply for RFA AR 10 005
Apply for RFA AR 10 005
- 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 Apr 17, 2009 and posted on Apr 17, 2009.
- Applicants must submit their applications by Aug 31, 2009. (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: Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses City or township 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 County governments State governments 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 Independent school districts Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education Public and State controlled institutions of higher education.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIAMS Clinical Trial Outcomes Instrument Development Grant Program (U01), announced under Funding Opportunity Number RFA-AR-10-005, is a National Institutes of Health funding opportunity focused on creating and testing better ways to measure outcomes in clinical trials for conditions within the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The core idea is to support research teams that can develop new outcome measures and instruments that are both clinically meaningful and important to patients, especially tools that help evaluate adverse events and clarify how a treatment's efficacy in controlled settings relates to its real-world effectiveness. In practice, this means NIAMS is looking for measurement tools that can be used to judge not only whether a therapy works, but also how it performs across different contexts and populations, what harms or side effects occur, and how those benefits and risks can be captured in a reliable, standardized way.
A key emphasis of the program is instrument development and early evaluation rather than running a full-scale therapeutic trial. The awards are intended to move promising outcome measures from concept to initial validation, producing instruments that are ready to be taken into existing or future clinical trials for more extensive testing. NIAMS is aiming for measures that could gain broad acceptance and real uptake by the research and clinical communities, meaning applicants are generally expected to think beyond a single study and design tools that can be generalized, compared across studies, and ultimately used to improve diagnosis, treatment decision-making, or the evaluation of cures for NIAMS-relevant diseases, illnesses, and injuries. Because the outcomes are meant to be "clinically relevant" and "patient important," successful projects typically need to show a clear connection to patient experience and real clinical decision points, not just laboratory markers.
This opportunity uses the U01 cooperative agreement mechanism, which is different from a standard research grant in that it generally involves substantial scientific or programmatic involvement by NIH staff during the project. In other words, it is structured as a partnership-style arrangement where NIAMS may have an active role in guiding aspects of the work to help ensure the resulting instruments are useful, rigorous, and aligned with broader community needs. The funding category is health-related (CFDA 93.846: Arthritis, Musculoskeletal and Skin Diseases Research), and there is no cost-sharing or matching requirement.
In terms of scale and competitiveness, NIAMS planned an estimated total of about $1,000,000 in FY 2010 for this program, with an anticipated four to five awards. The award ceiling listed is $150,000, signaling that these projects are meant to be targeted and outcomes-focused rather than large multi-year clinical trials. An important constraint is that the awards are not renewable, so applicants would need to plan a work program that delivers a meaningful, publishable, and field-ready product within the supported period, while also positioning the instrument for follow-on testing and adoption through other trials or funding mechanisms.
Eligibility is broad and includes many types of institutions and organizations. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), and a wide range of governmental entities (state, county, city/township, special district, and independent school districts). Tribal governments and tribal organizations are also eligible, including federally recognized tribes and other tribal entities. The eligibility list further extends to historically underrepresented and mission-specific institutions and organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. Notably, non-U.S. entities (foreign organizations), regional organizations, and U.S. territories or possessions are also included, reflecting NIAMS interest in measurement tools that may have broader applicability across settings and populations.
Administrative details in the source notice indicate the FOA was posted on April 17, 2009, with an original and current closing date of August 31, 2009, and an archive date of October 1, 2009. The sponsoring agency is the National Institutes of Health, and the program is administered through NIAMS. Applicants or interested parties who need the official archived announcement and full requirements were directed to the NIH grants page for the FOA, and technical access issues were routed to the NIH Office of Extramural Research webmaster contact.
Frequently Asked Questions (FAQs)
What is the NIAMS Clinical Trial Outcomes Instrument Development Grant Program (U01)?
It is an NIH/NIAMS funding opportunity focused on developing and testing better outcome measurement instruments for clinical trials in conditions within the NIAMS mission (arthritis, musculoskeletal, and skin diseases, illnesses, and injuries). The goal is to create tools that can measure treatment outcomes in a reliable and standardized way, including benefits and harms.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number (FOA) is RFA-AR-10-005.
What does NIAMS mean by "outcomes instruments" in this program?
In this context, outcomes instruments are measures or tools used in clinical trials to evaluate how well a therapy works and what effects it has. NIAMS is seeking instruments that are clinically meaningful and important to patients, and that can capture both positive outcomes and adverse events in a standardized, reliable manner.
What kinds of research does this opportunity support?
The program supports instrument development and early evaluation rather than a full-scale therapeutic clinical trial. Projects are intended to move outcome measures from concept to initial validation so they are ready for use in existing or future clinical trials for broader testing.
Is this funding meant to support running a full clinical trial of a treatment?
No. A key emphasis is on developing and initially evaluating outcome measurement tools, not conducting a large therapeutic trial. The expected deliverable is a field-ready measurement instrument that can later be used in clinical trials.
What types of outcomes are emphasized (efficacy, effectiveness, adverse events)?
NIAMS emphasizes tools that help evaluate adverse events and that clarify how a treatment's efficacy under controlled trial conditions relates to real-world effectiveness. Instruments should support credible measurement of benefits and risks across different contexts and populations.
What does "clinically relevant" and "patient important" mean in this FOA?
It means the instrument should be tied to real clinical decision points and reflect patient experience, not solely laboratory markers. Projects are expected to show a clear connection between what is being measured and what matters to patients and clinicians.
What is the funding mechanism used for this opportunity?
This opportunity uses the U01 cooperative agreement mechanism.
How is a U01 cooperative agreement different from a standard research grant?
A U01 is generally structured as a partnership-style arrangement where NIH staff may have substantial scientific or programmatic involvement during the project. NIAMS may play an active role in guiding aspects of the work to help ensure the resulting instruments are rigorous, useful, and aligned with broader community needs.
Which NIH institute administers this program?
The program is sponsored by the National Institutes of Health and administered through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What is the CFDA number and program area for this funding?
The funding category is health-related under CFDA 93.846: Arthritis, Musculoskeletal and Skin Diseases Research.
How much total funding was NIAMS planning for this program?
NIAMS planned an estimated total of about $1,000,000 in FY 2010 for this program.
How many awards were anticipated?
NIAMS anticipated making four to five awards.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $150,000.
Does this program require cost sharing or matching funds?
No. The source notice states there is no cost-sharing or matching requirement.
Are awards under this FOA renewable?
No. The awards are described as not renewable.
What does "not renewable" imply for project planning?
It implies applicants should plan a work program that delivers a meaningful, publishable, and field-ready outcome instrument within the supported period, while positioning the instrument for follow-on testing and adoption through other trials or funding mechanisms.
What types of organizations are eligible to apply?
Eligibility is broad and includes: public and private institutions of higher education; nonprofits (with and without 501(c)(3) status); for-profit organizations (including small businesses and other for-profits); and governmental entities (state, county, city/township, special district, and independent school districts).
Are tribal governments and tribal organizations eligible?
Yes. Tribal governments (including federally recognized tribes and other tribal entities) and tribal organizations are included as eligible applicants.
Are historically underrepresented or mission-specific institutions eligible?
Yes. The eligibility list includes organizations such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The eligibility list includes non-U.S. entities (foreign organizations), as well as regional organizations and U.S. territories or possessions.
What is the main product or deliverable NIAMS is looking for?
NIAMS is looking for outcome measures and instruments that are developed and initially validated so they are ready to be used in clinical trials, with an emphasis on tools that can gain broad acceptance and real uptake by research and clinical communities.
Does NIAMS expect the instrument to be useful beyond a single study?
Yes. Applicants are generally expected to think beyond a single study and design tools that can be generalized, compared across studies, and used to improve diagnosis, treatment decision-making, or evaluation of cures for NIAMS-relevant conditions.
Why does NIAMS emphasize standardized and reliable instruments?
Standardization and reliability help ensure benefits and risks can be captured consistently, compared across contexts and populations, and used by the broader community to interpret clinical trial results and translate them into real-world practice.
When was this FOA posted, and what were the key dates?
The FOA was posted on April 17, 2009. The original and current closing date was August 31, 2009. The archive date was October 1, 2009.
Where were applicants directed to find the official archived announcement and full requirements?
Applicants were directed to the NIH grants page for the FOA to access the official archived announcement and full requirements.
Who was listed as the contact for technical access issues?
Technical access issues were routed to the NIH Office of Extramural Research webmaster contact.
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