Research on the Impact of and Methods for Implementing Regional Genomic Medicine eConsult Services (U01 Clinical Trials Optional)
National Human Genome Research Institute
National Institutes of Health
This Notice of Funding Opportunity (NOFO) invites applications for sites to participate in the Genomic Medicine eConsult Research Network, hereafter referred to as the ‘eConsult Network.' The eConsult Network will consist of 2-3 sites working with NHGRI to conduct research on the impact of and methods for implementing regional clinician-to-clinician genomic medicine electronic consult (eConsult) services. Specifically, sites will be funded to research how to best design, implement, and sustain regional genomic medicine eConsult services; provide outreach to potential users, including those at underserved settings; and assess the impact on key stakeholders while developing successful implementation strategies and resources that can be broadly shared and adopted.
Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional)
National Institute on Drug Abuse
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
The purpose of this notice of funding opportunity (NOFO) is to encourage theoretically driven pilot and/or feasibility research in the following areas: 1) the development and pilot testing of new or adapted interventions to prevent or delay the initiation of substance use and/or the progression from use to misuse or disorder and 2) services research examining questions specific to the prevention of substance use. The latter may include pilot studies of strategies or approaches to intervention, and/or other service system-based research to address areas such as economics, funding, service quality and engagement. In addition to the prevention of substance use, misuse and disorder, other outcomes of interest for the research supported through this NOFO include a reduction in negative sequalae of use, such as deaths related to impaired driving, suicidal behavior (e.g., nonfatal and fatal attempts), and substance-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings.
NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
NIDDK supports investigator-initiated, high-risk multi-center (more than one center) clinical studies through a two-part process that may include an implementation planning cooperative agreement (U34). The U34 is designed to: 1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study. The proposed clinical study should be hypothesis-driven and focus on a disease in the mission of NIDDK. Consultation with NIDDK scientific staff is strongly encouraged prior to the submission of the U34 application.
NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see PAR-24-094). Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.
NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)
National Institute of Neurological Disorders and Stroke
National Institutes of Health
This NOFO encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.
The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.
It is NINDS's intent that all NINDS-supported multi-center clinical trials in stroke treatment, recovery, or prevention will be conducted within the NIH StrokeNet. Only in exceptional circumstances will NINDS consider funding multi-site stroke clinical trials outside of this network.
This NOFO uses the bi-phasic, milestone driven UG3/UH3 cooperative agreement activity code. Awards made under this NOFO will initially support a one-year milestone-driven planning and start-up phase, with possible transition to an implementation (UH3) phase of up to 6 additional years. Only UG3 projects that meet the scientific milestones and award requirements of the UG3 phase may transition to the UH3 phase. Applications submitted in response to this FOA must address both the UG3 and UH3 phases and are expected to include plans for project management and performance milestones for each phase.
Clinical-Community Linkages to Address Unmet Social Needs and Adverse Social Determinants of Health to Advance Health Equity among Populations Experiencing Health Disparities: The Bridge-to-Care Initiative (R01 Clinical Trial Optional)
National Institute of Nursing Research
National Institutes of Health
Care delivery has traditionally approached a patient’s health as separate and distinct from their social context. This practice must be reimagined to make meaningful improvements in health, eliminate health disparities, and advance health equity. The purpose of the Bridge-to-Care Initiative is to advance research that leverages healthcare-community partnerships to address unmet health-related social needs among individuals and families and adverse social determinants of health (SDOH) within communities.
Early-Stage Development of Informatics Technologies for Cancer Research and Management (U01 Clinical Trial Optional)
National Cancer Institute
National Institutes of Health
The purpose of this Notice of Funding Opportunity (NOFO) is to invite Cooperative Agreement (U01) applications for the development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology, and/or cancer health disparities. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO focuses on early-stage development from prototyping to hardening and adaptation. Early-stage development is defined for the purpose of this NOFO as initial tool development or the significant modification of existing tools for new applications. The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. In order to be successful, proposed development plans must have a clear rationale on why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from users and collaborators throughout the development process must be included.
Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders (UG3/UH3 Clinical Trial Optional)
National Institute on Drug Abuse
National Institutes of Health
The purpose of this funding opportunity is to support the development of Clinical Outcome Assessments (COA) for Substance Use Disorders (SUD). The COA development plan is expected to progress into the FDA drug development tool qualification program.
This notice of funding opportunity (NOFO) utilizes the UG3/UH3 Phased Innovation Awards Cooperative Agreement grant mechanism that includes two phases. The applications responding to this NOFO should contain a COA development plan that will cover both UG3 and UH3 phases. In the first 2-year UG3 phase the project must have a set of operational milestones to be completed by the end of this period. Once NIDA program has evaluated the progress of the UG3 phase and determined that the UG3 phase has been successfully completed, it transitions to the UH3 phase to be funded for three additional years. The goal of this NOFO is to expand the armamentarium of COA that are FDA qualified as drug development tool (DDT) in the context of use (COI) of a SUD. Achieving this goal will greatly facilitate the development of treatments for SUDs.