Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed) | PAR 19 171

Opportunity Information: Apply for PAR 19 171

The Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed) funding opportunity (PAR 19-171) is a National Institutes of Health program run through the National Institute of Neurological Disorders and Stroke (NINDS). It supports investigator-initiated comparative effectiveness research (CER) in areas that fit the NINDS mission, meaning projects should focus on neurological disorders and stroke-related questions that matter to real-world patient care. The intent is to generate evidence that can directly inform clinical decisions by comparing preventive strategies, diagnostic approaches, or interventions such as drugs, biologics, devices, and surgical, behavioral, or rehabilitation therapies. A key theme is practicality: proposed studies should gather data in a cost-effective way while still producing findings that have a meaningful impact on current clinical practice.

This FOA uses a phased, milestone-driven cooperative agreement structure, which means the project is funded and managed in two connected stages with clear go/no-go checkpoints. The first stage is the UG3 planning phase, which can last up to two years. During UG3, teams are expected to do the scientific and operational groundwork needed to run a strong observational CER study. Scientific planning can include small-scale data collection to test feasibility or acceptability, such as whether participants will provide the needed information, whether data elements can be collected reliably, how well planned analyses will work, and whether data storage and handling methods are suitable. Operational planning is also central and must cover the mechanics required for success, including recruitment and retention plans, development of case report forms, creation or refinement of data management systems, and tools and procedures for data quality and overall study management.

If, and only if, the UG3 milestones and feasibility requirements are met, the award can transition into the UH3 phase, which supports the actual conduct of the investigator-initiated observational study for up to five additional years. In other words, applicants submit one integrated UG3/UH3 application from the start, but funding for the longer UH3 implementation phase is contingent on demonstrating readiness and feasibility during UG3. The overall design pushes applicants to be disciplined about planning, proof-of-feasibility, and operational execution before launching a larger, more expensive observational effort.

This opportunity is explicitly labeled "Clinical Trial Not Allowed," which signals that the supported work must be observational rather than an interventional clinical trial. The research can still evaluate and compare interventions in the sense of examining how different treatments or strategies perform in real-world practice, but the study design should not assign participants to interventions in a way that meets NIH’s definition of a clinical trial. The goal is to leverage efficient data collection approaches that can produce credible comparative evidence without the complexity and costs of running a randomized intervention trial under this mechanism.

Eligibility is broad and includes many types of organizations that can carry out health research, such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and a wide range of government entities (state, county, city/township, special district). It also welcomes participation from tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, and others. The FOA specifically notes additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations, reflecting an intent to include diverse institutions and settings where neurological care and outcomes are studied.

Administratively, this is a discretionary funding opportunity using the cooperative agreement funding instrument, categorized under health and associated with CFDA 93.853. The sponsoring agency is NIH, and the original closing date listed for the opportunity was March 21, 2022. The notice does not specify an award ceiling or expected number of awards in the provided excerpt, but the structure clearly indicates that applicants should budget and plan for a two-year planning period with the possibility of a longer observational study phase if predefined milestones are achieved. For alignment and topic fit, applicants are directed to NINDS mission and research priorities, which are maintained on the NINDS website.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2019-01-28.
• Applicants must submit their applications by 2022-03-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 19 171

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