Opportunity Information: Apply for RFA AG 12 006

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Leveraging Existing Data or Longitudinal Studies to Evaluate Safety and Effectiveness of Pharmacological Management of Chronic Pain in Older Adults (R03)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
  • This funding opportunity was created on Jul 19, 2011 and posted on Jul 19, 2011.
  • Applicants must submit their applications by Nov 3, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $375,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $50,000.00 in funding.
  • Eligible applicants include: For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) City or township governments 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 Private institutions of higher education Public housing authorities/Indian housing authorities Small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts.
  • 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.
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Opportunity Summary:

The National Institutes of Health released this Funding Opportunity Announcement (RFA-AG-12-006) to support small, focused research projects that use existing data to better understand how chronic pain is treated with medications in older adults, and what outcomes those treatments produce. Rather than funding new clinical trials, the program is designed to help researchers make strong, efficient use of resources that already exist, such as administrative claims databases, electronic health records, past clinical trial datasets, patient registries, and long-running cohort or longitudinal studies. The core goal is to evaluate safety and/or effectiveness of pharmacological management strategies for chronic pain in later life, with particular interest in commonly used medication classes like non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, including situations where medications are combined with non-pharmacologic approaches.

Projects funded under this opportunity are expected to generate practical evidence about real-world treatment outcomes in older populations, where medication risks, comorbidities, polypharmacy, and age-related physiology often make pain management more complicated. The FOA emphasizes that innovative study designs and analytic approaches are welcome, especially those that can extract meaningful conclusions from large observational datasets or long-term follow-up data. In other words, the program is aimed at improving what is known about which treatments work best for which older patients, under what circumstances, and with what tradeoffs in terms of adverse events and overall functioning.

The announcement highlights several example topic areas. One area is identifying predictors of treatment outcomes at different levels, including patient-level factors (such as age, comorbidities, cognitive status, frailty, kidney function, prior medication exposure, or history of falls), medication-level factors (dose, duration, drug-drug interactions, switching patterns, or concurrent sedating medications), provider-level factors (prescribing patterns, specialty, monitoring practices), and system-level factors (care setting, access to non-drug therapies, formulary rules, or continuity of care). Another area is comparative safety and comparative effectiveness research, such as comparing different drug classes, different opioid regimens, NSAID strategies, or combinations of pharmacologic and non-pharmacologic interventions to see how they differ in pain relief, function, quality of life, hospitalizations, falls, fractures, gastrointestinal bleeding, cardiovascular events, renal complications, delirium, or mortality. A third area encourages methodological work that links multiple datasets to answer pain-related questions, for example connecting claims to electronic health record measures, registry data, or longitudinal cohort assessments to improve exposure measurement, outcome capture, or confounding control. A fourth area focuses on evaluating pain measures or indices that might guide clinical decisions, including how pain metrics can be used to decide when to start, adjust (titrate), or stop medications, particularly in subgroups like older adults with dementia where pain assessment is challenging and risks of adverse drug effects may be higher.

This funding mechanism is an NIH Small Research Grant (R03), which typically supports smaller-scope projects that can be completed relatively quickly and that often serve as stepping stones toward larger studies. For this specific announcement, the total estimated funding was $375,000, with an award ceiling of $50,000. There is no cost-sharing or matching requirement. The opportunity falls under the Health activity category and is associated with CFDA number 93.866 (Aging Research), reflecting a clear focus on aging-related clinical and health services research questions.

Eligibility is broad and includes many types of domestic U.S. organizations and governments, such as state, local, tribal, and county governments; public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status); public housing authorities; independent school districts; special district governments; and for-profit organizations (other than small businesses), as well as small businesses themselves. The FOA also explicitly allows applications from U.S. territories or possessions and from non-U.S. entities (foreign institutions). In addition, it calls out eligibility for several institution types and community-focused organizations, including Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, and eligible federal agencies, reflecting an intent to encourage wide participation and diverse research settings.

Key dates show this was a time-limited solicitation posted July 19, 2011, with an application closing date of November 3, 2011, and an archive date of December 4, 2011. Applicants were directed to the full announcement on the NIH Grants Guide website, and NIH’s Office of Extramural Research web support contacts were provided for access or linking issues. Overall, the opportunity is best understood as a targeted NIH aging research initiative to produce actionable evidence on medication-based chronic pain management in older adults by intelligently reusing and connecting existing data sources, with special emphasis on the benefits and risks of NSAIDs and opioids in real-world older populations.

FAQs: NIH RFA-AG-12-006 (R03) - Chronic Pain Medication Management in Older Adults Using Existing Data

What is the purpose of this funding opportunity (RFA-AG-12-006)?

This NIH Funding Opportunity Announcement supports small, focused research projects that use existing data to better understand how chronic pain is treated with medications in older adults and what outcomes those treatments produce. The central aim is to evaluate the safety and/or effectiveness of pharmacological strategies for chronic pain in later life, especially in real-world older populations where comorbidities, polypharmacy, and age-related physiological changes can increase both complexity and risk.

Does this program fund new clinical trials?

No. The opportunity is designed to support research that reuses resources that already exist rather than funding new clinical trials. The focus is on generating evidence efficiently by analyzing previously collected data.

What kinds of data sources are expected to be used?

Projects are expected to rely on existing datasets such as administrative claims databases, electronic health records (EHRs), past clinical trial datasets, patient registries, and long-running cohort or longitudinal studies.

What kinds of treatments are of particular interest?

The FOA emphasizes pharmacological management strategies for chronic pain in older adults, with particular interest in commonly used medication classes such as non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. It also includes situations where medications are combined with non-pharmacologic approaches.

What types of research questions fit this announcement best?

Projects should aim to produce practical evidence about real-world outcomes of chronic pain medication treatment in older adults. The announcement is oriented toward questions such as which treatments work best for which older patients, under what circumstances, and what tradeoffs exist (for example, symptom improvement versus adverse events or functional decline).

Is the focus on effectiveness, safety, or both?

Both. The core goal is to evaluate safety and/or effectiveness of pharmacological management strategies for chronic pain in later life. Applicants can focus on either domain or address both together, depending on the data and the study design.

What outcomes does the FOA suggest studying?

Examples of outcomes highlighted include pain relief, function, quality of life, hospitalizations, falls, fractures, gastrointestinal bleeding, cardiovascular events, renal complications, delirium, and mortality.

What does the FOA mean by "real-world" evidence for older adults?

It refers to evidence generated from routine clinical care or long-term observational follow-up rather than newly initiated trials. The intent is to understand how chronic pain medications perform among older people in typical care settings, where issues like multiple chronic conditions, multiple concurrent medications, and heightened vulnerability to adverse effects are common.

Are innovative study designs and analytic methods encouraged?

Yes. The FOA explicitly welcomes innovative study designs and analytic approaches, especially those capable of extracting meaningful conclusions from large observational datasets or long-term follow-up data.

What are the example topic areas described in the announcement?

The FOA provides several example topic areas, including: (1) identifying predictors of treatment outcomes at patient, medication, provider, and system levels; (2) comparative safety and comparative effectiveness research across drug classes, regimens, and combinations of pharmacologic and non-pharmacologic interventions; (3) methodological work linking multiple datasets to strengthen exposure measurement, outcome capture, or confounding control; and (4) evaluation of pain measures or indices that could guide clinical decisions such as initiating, titrating, or stopping medications.

What are examples of patient-level predictors the FOA highlights?

Examples include age, comorbidities, cognitive status, frailty, kidney function, prior medication exposure, and a history of falls.

What are examples of medication-level predictors the FOA highlights?

Examples include dose, duration, drug-drug interactions, switching patterns, and the use of concurrent sedating medications.

What are examples of provider-level predictors the FOA highlights?

Examples include prescribing patterns, provider specialty, and monitoring practices.

What are examples of system-level predictors the FOA highlights?

Examples include care setting, access to non-drug therapies, formulary rules, and continuity of care.

What does "comparative safety" and "comparative effectiveness" mean in this FOA?

In the context of this announcement, it means comparing different medication classes, regimens (including opioid regimens and NSAID strategies), or combined approaches (pharmacologic plus non-pharmacologic) to see how they differ in outcomes such as pain relief and function, as well as adverse events like falls, bleeding, cardiovascular events, renal complications, delirium, or mortality.

Does the FOA support projects that link multiple datasets together?

Yes. A specific example area encourages methodological work that links multiple datasets (for example, connecting claims data to EHR measures, registries, or longitudinal cohort assessments) to improve how treatments and outcomes are measured and to strengthen approaches to addressing confounding.

Is pain measurement itself a topic of interest?

Yes. The FOA highlights evaluating pain measures or indices that might guide clinical decision-making, including how pain metrics could be used to determine when to start, adjust (titrate), or stop medications.

Does the announcement mention subgroups such as older adults with dementia?

Yes. The FOA specifically notes that pain assessment can be challenging in subgroups like older adults with dementia, and that risks of adverse drug effects may be higher in such groups. Projects focused on measurement or decision-support approaches in these populations are consistent with the example topics provided.

What funding mechanism is used for this opportunity?

This opportunity uses the NIH Small Research Grant mechanism (R03), which typically supports smaller-scope projects that can be completed relatively quickly and may serve as stepping stones toward larger studies.

How much funding is available under this announcement?

The total estimated funding described is $375,000, with an award ceiling of $50,000.

Is cost-sharing or matching required?

No. The announcement states there is no cost-sharing or matching requirement.

What is the activity category and CFDA number associated with this opportunity?

The opportunity falls under the Health activity category and is associated with CFDA 93.866 (Aging Research).

Who is eligible to apply?

Eligibility is broad and includes many types of domestic U.S. organizations and governments (state, local, tribal, county), public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), public housing authorities, independent school districts, special district governments, for-profit organizations (other than small businesses), and small businesses. The FOA also allows applications from U.S. territories or possessions and from non-U.S. entities (foreign institutions). Eligible applicants explicitly include institution types such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, and eligible federal agencies.

Are foreign institutions allowed to apply?

Yes. The FOA explicitly allows applications from non-U.S. entities (foreign institutions).

Are U.S. territories or possessions allowed to apply?

Yes. The FOA explicitly allows applications from U.S. territories or possessions.

Is this opportunity still open?

No. The key dates indicate it was posted July 19, 2011, had an application closing date of November 3, 2011, and an archive date of December 4, 2011, indicating it was time-limited and is now archived.

Where were applicants directed to find the full announcement and support contacts?

Applicants were directed to the full announcement on the NIH Grants Guide website. NIH Office of Extramural Research web support contacts were provided for access or linking issues.

What is the overall theme or takeaway of this FOA?

It is a targeted NIH aging research initiative intended to produce actionable evidence about medication-based chronic pain management in older adults by reusing and, when appropriate, linking existing data sources. It places special emphasis on understanding benefits and risks of widely used medications like NSAIDs and opioids in real-world older populations.

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