NINDS PHASE III Investigator Initiated Multi Site Clinical Trials (U01) | Apply Online

Opportunity Summary:

The grant opportunity titled "NINDS PHASE III Investigator Initiated Multi Site Clinical Trials (U01)" (Funding Opportunity Number PAR-11-173) is a National Institutes of Health (NIH) funding announcement designed to support large, definitive Phase III clinical trials in neurology that are initiated and led by investigators rather than by the government. The core purpose of the program is to provide a formal mechanism for researchers to propose and run multi-site, randomized, controlled Phase III trials that test interventions in a rigorous, real-world clinical setting. These studies are meant to answer high-impact questions about neurological disorders and stroke, consistent with the National Institute of Neurological Disorders and Stroke (NINDS) mission and strategic priorities, with NINDS serving as the NIH institute receiving and overseeing these applications.

This FOA specifically emphasizes multi-site randomized controlled trials at the Phase III stage, meaning the proposed research is expected to be beyond early feasibility and preliminary efficacy testing. In practice, this implies that applicants should already have substantial supporting evidence and a well-developed trial plan, since Phase III trials typically aim to confirm efficacy, monitor adverse events, compare with standard or existing approaches, and generate evidence strong enough to influence clinical practice, guidelines, or policy. The announcement allows trials addressing any research question that fits within the NINDS mission, which broadly covers disorders of the brain and nervous system, including stroke and other neurological diseases. Applicants are directed to the NINDS website for details on its mission, strategic plan, and research interests to ensure alignment between the proposed trial and institute priorities.

The funding mechanism is a U01 cooperative agreement. A cooperative agreement differs from a standard research project grant in that it anticipates substantial programmatic involvement by the funding institute during the life of the award. While the investigator and their team remain responsible for leading and conducting the study, the cooperative structure generally means NINDS may have an active partnership role in areas such as trial oversight, milestone tracking, data and safety monitoring expectations, and coordination around operational or scientific issues that arise during a complex, multi-site trial. The funding instrument type is listed as a cooperative agreement, and the activity category is Health, under CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). No cost sharing or matching is required, which means applicants are not obligated to contribute a defined non-federal share of the project costs as a condition of the award.

Eligibility is broad and includes a wide range of organizations that could credibly organize and manage a large clinical trial network. Eligible applicants include for-profit entities (including those other than small businesses), small businesses, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits), private and public institutions of higher education, and multiple levels of government entities such as state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The eligibility information also notes additional categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, U.S. territories or possessions, regional organizations, certain tribal organizations and tribal governments (including categories beyond federally recognized tribes as listed), and even non-U.S. entities (foreign organizations). This broad eligibility signals that NINDS is open to well-qualified applicants across academia, health systems, research institutes, community-based settings, and other capable organizations, provided the proposed work is feasible and aligned with NINDS goals.

Key timeline fields in the source data show the FOA was posted on March 22, 2011, with an original closing date of May 7, 2013, and a current closing date of July 22, 2013. An archive date of August 22, 2013 is also provided, indicating the opportunity is historical and no longer active under those dates, though it remains useful as a reference point for understanding how NINDS structured Phase III clinical trial solicitations at that time. The "Additional Information" link points to the NIH Grants Guide page for PAR-11-173, where the full requirements, application instructions, and detailed expectations would be found. For technical issues accessing the announcement, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is specifically a support contact for announcement access and linking problems rather than a scientific/programmatic contact for trial design questions.

In plain terms, this FOA was intended for experienced clinical trial teams ready to run large, randomized, controlled Phase III studies across multiple sites, with the goal of producing strong evidence that can change how neurological diseases and stroke are treated or managed. It funded that work through a cooperative agreement model that supports close interaction with NINDS during trial execution, and it invited applications from a very wide range of capable organizations without requiring cost sharing.

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