Advancing Research to Develop Improved Measures and Methods for Understanding Multimorbidity (R01 Clinical Trial Optional) | PAR 20 179

FAQs: NIH PAR-20-179 (R01 Clinical Trial Optional) - Multimorbidity Measures and Methods

What is the goal of PAR-20-179?

The opportunity supports research to strengthen how multimorbidity (also called multiple chronic conditions, or MCCs) is measured, captured, and analyzed. The emphasis is on improving data resources, measurement tools, and analytic methods used to understand how chronic conditions cluster, evolve, and affect patients over time.

What does NIH mean by "multimorbidity" or "multiple chronic conditions (MCCs)" in this funding opportunity?

In this context, multimorbidity refers to people living with more than one chronic condition at the same time. The FOA focuses on better ways to represent the complexity of co-occurring chronic diseases across different ages, backgrounds, and care settings.

Is this funding opportunity primarily about testing new interventions?

No. The central focus is not on testing new interventions. It is designed to advance the underlying measures and methods (data, tools, indices, algorithms, and analytics) that enable stronger multimorbidity research and more meaningful comparisons across studies and populations.

What types of projects fit this FOA best?

Projects that develop, discover, or evaluate improved measures, tools, and analytic methods for studying MCCs. Examples described in the FOA include new indices, phenotyping strategies, algorithms, or measurement frameworks that capture timing, sequencing, severity, and trajectories of multiple conditions.

Why does the FOA emphasize moving beyond simple condition counts?

The FOA is intended to push the field beyond counting diagnoses and toward approaches that better reflect real-world complexity. Multimorbidity is dynamic, can change over time, and is shaped by factors such as aging, social context, and access to care. Improved measures are meant to better capture that complexity.

Does the FOA prioritize longitudinal approaches?

Yes. A major priority is developing and evaluating measures or tools that reflect the longitudinal nature of multimorbidity, including how disease combinations emerge, change, and interact across years rather than being measured at a single time point.

What kinds of longitudinal features are applicants encouraged to capture?

The FOA encourages methods that can represent timing, sequencing, severity, and trajectories of conditions over time, recognizing that MCC patterns can evolve and interact across the life course.

Are patient-reported outcomes and patient-centered measures within scope?

Yes. Patient-focused measurement is a core theme. The FOA explicitly seeks studies that incorporate patient reports and related constructs such as functional limitations and quality of life, reflecting that diagnoses alone may not adequately describe multimorbidity burden and day-to-day impact.

What might patient-focused measurement work include under this FOA?

Examples include developing or validating patient-reported instruments, improving how patient-reported data are collected or interpreted in multimorbidity contexts, or integrating patient-reported outcomes with clinical data to create more complete MCC measures.

Does this FOA support research on shared pathways or "signatures" across multiple conditions?

Yes, to the extent that the work advances measures and methods that support basic and translational discovery related to shared MCC pathways. The FOA highlights measures or methods that help identify shared biological "signatures" across conditions and calls for early-stage biological, analytical, and clinical evaluation of those signatures.

What does "early-stage evaluation" of shared signatures mean here?

Based on the description provided, it refers to work that helps determine whether proposed markers or patterns are meaningful, reproducible, and useful for understanding multimorbidity, strengthening the scientific foundation for later mechanistic or interventional studies.

Are animal models of MCCs relevant to this FOA?

They can be. The FOA notes the value of measures or methods that help researchers use animal models of MCCs to explore mechanisms that might drive multiple conditions at once, or to identify shared signatures across conditions.

What kinds of analytic or methodological challenges does the FOA call out for multimorbidity research?

The FOA notes challenges such as high dimensionality (many conditions and combinations), confounding by indication and care patterns, changing risk over time, and differences in coding and documentation across settings. It encourages analytic approaches tailored to multimorbidity data and the populations being studied.

Is electronic health record (EHR) data a focus area?

Yes. The FOA emphasizes making better use of EHR data, including approaches that leverage the volume and richness of EHRs while addressing limitations such as missingness, measurement error, variable follow-up, and differences in clinical practice.

Can applicants use existing datasets, or do they need to collect new data?

Applicants may use existing data sources and may link datasets to explore new questions about MCCs. Strong applications can be built around secondary analyses, new linkages across clinical and non-clinical data, or enhanced measurement using already collected information, as long as the project materially advances MCC measurement or analytic capability.

Does the FOA encourage linking clinical and non-clinical data?

Yes. The FOA explicitly allows linking datasets, including linkages across clinical and non-clinical data, when it advances the measurement and analytic goals related to MCCs.

What is the overarching expected output or impact of funded work?

The goal is to produce tools and methods that increase the availability, quality, and utility of multimorbidity data so downstream studies across many diseases and populations can be more accurate, comparable, and clinically meaningful.

What grant mechanism is used for this opportunity?

This is an NIH R01 grant mechanism.

Are clinical trials required under this FOA?

No. Clinical trials are optional. Applicants may propose clinical trial elements if they are appropriate to the measurement or methods goals, but a clinical trial is not required.

If a team mainly wants to develop interventions for multimorbidity, is this the right FOA?

The provided description indicates this FOA is more squarely aimed at measurement and methodological advancement rather than intervention development. It also notes that applicants whose primary interests are identifying shared mechanisms or developing innovative interventions should consider a separate NIH announcement referenced as PAR-XX-XXX.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations and governmental entities. Examples listed include state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; and other eligible entities.

Are certain institution types specifically encouraged or highlighted?

Yes. The FOA highlights interest in applications from a range of institution types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Can non-U.S. (foreign) institutions apply as the primary applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, based on the description provided.

Are non-domestic components of U.S. organizations allowed?

No. The description states that non-domestic components of U.S. organizations are not eligible.

Can a project include a foreign component at all?

Yes, foreign components (as defined under NIH policy) may be included when scientifically justified, even though foreign institutions cannot apply as the primary applicant and non-domestic components of U.S. organizations are not eligible.

What is the opportunity number for this FOA?

The opportunity number is PAR-20-179.

Which agency is offering this funding opportunity?

The agency is the National Institutes of Health (NIH).

What is the listed close date in the provided information?

The original closing date listed in the provided excerpt is 2024-01-07.

Does the provided excerpt state an award ceiling or number of awards?

No. The description provided does not specify an award ceiling or the expected number of awards, and notes that applicants would need to consult the full FOA and NIH institute-specific guidance for budget expectations, project period norms, and related participation details.

Are there CFDA listings associated with this opportunity?

Yes. The excerpt references CFDA listings 93.121, 93.173, 93.213, 93.399, and 93.866.

What activity categories are associated with this opportunity (as provided)?

The activity categories listed are related to education and health.