Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)

The Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) funding opportunity is a forecasted grant program from the National Institutes of Health, an agency within the U.S. Department of Health and Human Services. This initiative is expected to be administered in collaboration with participating Institutes and Centers, including those focused on cardiovascular, lung, blood, and sleep disorder research. The NIH is a leading federal biomedical research agency that supports scientific discovery and translational research to improve public health outcomes. This opportunity reflects NIH’s continued emphasis on advancing complex clinical trials that address critical health challenges through collaborative and multi-site approaches. The primary purpose of this funding opportunity is to support the development and execution of investigator-initiated clinical trials that may include efficacy, effectiveness, pragmatic, or implementation research. The program specifically targets multi-site trials, although it also allows for large or complex trials conducted at a single site or through decentralized or virtual models without traditional physical clinical locations. Applicants are required to propose projects that align with the NIH definition of a clinical trial and demonstrate relevance to the mission of the participating Institutes and Centers. The opportunity encourages early collaboration among investigators and institutions to design impactful and scientifically rigorous studies. Funding will be provided through a cooperative agreement mechanism using a bi-phasic structure consisting of a UG3 planning phase and a UH3 implementation phase. The UG3 phase, lasting up to two years, is intended for start-up activities including finalizing protocols, establishing infrastructure, and meeting predefined milestones. Successful completion of these milestones enables transition to the UH3 phase, which supports full-scale clinical trial implementation and participant enrollment for up to five additional years. The total project duration may extend up to seven years, allowing for comprehensive trial execution and data analysis. While specific funding amounts are not yet disclosed, the structure implies substantial support for complex, multi-year clinical research efforts. Eligibility for this opportunity is broad and inclusive, encompassing a wide range of applicant types. Eligible entities include state and local governments, public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit organizations including small businesses, independent school districts, public housing authorities, and tribal governments and organizations. Additional eligible applicants include federal agencies, U.S. territories, regional organizations, faith-based and community-based organizations, and non-U.S. entities. This wide eligibility scope reflects NIH’s commitment to fostering diverse participation in clinical research across sectors and geographic regions. The application process has not yet opened, as this is a forecasted opportunity intended to provide advance notice. The estimated posting date is November 16, 2026, with an anticipated application due date of February 16, 2027. Applicants will be expected to submit comprehensive proposals that include a detailed scientific rationale, operational plan, and strategies for project coordination, data management, and biostatistical support. Evaluation criteria will likely focus on scientific merit, feasibility, innovation, and the ability to successfully execute a complex clinical trial across multiple sites. Award decisions are expected around October 1, 2027, with project start dates projected for December 1, 2027. The NIH encourages investigators to begin forming collaborations and developing proposals well in advance of the official solicitation release. While specific contact individuals are not listed, applicants are directed to communicate via email with the National Heart, Lung, and Blood Institute, particularly within the Division of Cardiovascular Sciences. This forecast notice serves as an early engagement opportunity for prospective applicants to prepare competitive submissions for a significant federal research funding program.