Key Dates
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK) intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications for the TrialNet Clinical Network Hub (HUB). The purpose of this Notice of Funding Opportunity (NOFO) is to continue support for the Type 1 Diabetes TrialNet Clinical Network Hub (HUB), a screening and clinical activities coordination unit for clinical trials focusing on the prevention of and early intervention in type 1 diabetes (T1D). The main objective of the HUB is to increase the efficiency and productivity of the TrialNet network by providing coordination of communications and outreach and developing new tools and approaches to increase screening, recruitment and retention. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The NOFO is expected to be published in Spring 2024 with an expected application due date in Summer 2024.
This NOFO will utilize the U01 activity code. Details of the planned NOFO are provided below.
This Notice encourages investigators with expertise and insights into this area of type 1 diabetes prevention to begin to consider applying for this new NOFO.
For the next competitive funding period, the HUB’s major functions will include, but are not limited to:
1. HUB Activities to Enhance Risk Screening and Trial Recruitment Outreach:
Applicants should propose strategies including but not limited to novel approaches and technology to enhance TrialNet’s outreach. This will include the development of messaging and materials with input from the TrialNet team (the TNCC, the Clinical Centers and Affiliate Sites), children and adults with T1D as well as their families, T1D care providers, T1D research and support non-profit organizations (such as JDRF, Helmsley Trust, ADA, Children With Diabetes, etc.) and international T1D research centers. The HUB will also be charged with designing and implementing programs to increase the diversity of TrialNet participants as described in the PDEP guidance included in this NOFO. This is especially important since recent data shows that T1D incidence is rising fastest in children from minority groups, while those groups are currently underrepresented in TrialNet trials. https://pubmed.ncbi.nlm.nih.gov/36868256/ The HUB budget should include funds for enhancements and for the evaluation of the impact of any outreach programs.
2. HUB Activities to Support Clinical Trial and Ancillary Studies Operations:
During trial development, the HUB is responsible for: (1) working with TrialNet investigators, outside partners as needed, and the TNCC to finalize protocols and consent forms; (2) providing input to the TNCC on trial materials such as case report forms (CRFs); (3) participating in study site selection and activation as needed; (4) working with the TNCC to provide a participant recruitment plan; and (4) working with ancillary study project investigators as needed to determine project feasibility as well as alignment with TrialNet's mission.
During trial implementation, the HUB is responsible for: (1) coordinating screening and recruitment efforts across the network, including messaging content, social media outreach and updates; (2) evaluating clinical site productivity and gathering and disseminating information about productivity across the network, (3) overseeing, in collaboration with the TNCC, enrollment and retention, and developing outreach interventions to help clinical sites succeed; (4) working with the TrialNet Clinic Monitoring Group as well as the clinical sites to ensure appropriate protocol implementation and adherence to protocols; and (5) participating in site visits as needed.
During trial data analysis and publication, the HUB is responsible for: (1) assisting the TNCC and clinical sites in finalizing data reports; (2) working with the TrialNet Executive Committee to coordinate the communication of trial results to the investigators, patients and public; and (3) working with the TNCC and network investigators in the publication of the primary and, if applicable, secondary outcome manuscripts.
3. HUB Activities to Enhance Administration/Leadership:
The HUB will participate in the oversight of clinical aspects related to the development and implementation of trials and studies over the funding period, such as monitoring and evaluating Clinical Centers and weighing in on operational details (such as per-patient per-visit capitated reimbursements to clinical sites).
The HUB PD/PI will be a voting member of the TrialNet Executive Committee, will have a single vote as a member of the Steering Committee (which approves trials) and will serve on other network working groups. The HUB will work closely with the TNCC, Clinical Centers, Chair’s Office and NIDDK Program Officials in a collaborative and interactive manner.
4. Organization and Future Goals
During the project period, TrialNet will continue ongoing trials and will plan and prioritize new trials. TrialNet will also continue to participate, as a partner, with separately funded industry-, foundation- and NIH-sponsored new-onset trials. The exact number of protocols supported during the project period will depend on the nature and extent of the investigations proposed and the availability of funds. In addition, the network will continue to perform mechanistic studies in conjunction with trials as well as provide access to samples from participants in TrialNet clinical studies.
This next phase of TrialNet involves recompetition of the HUB (this NOFO) and TNCC (under a separate NOFO). The HUB’s responsibilities are detailed here, and applicants are advised to consult the companion NOFO to gain a full understanding of the TNCC’s responsibilities.
The HUB must submit a plan that details its tasks and responsibilities in coordination with plans for the network as a whole as described in this NOFO and in the companion (TNCC) NOFO. This plan must demonstrate the HUB’s ability to execute excellent and seamless communication and coordination and demonstrate an in-depth understanding of the overall operational conduct of complex multi-center trials.
TrialNet is complex and its trials are often lengthy, and operations could be disrupted and compromised without adequate succession plans in place. Applicants must propose inclusion of an assistant HUB PD/PI with a plan for their involvement that would allow them to fulfill the HUB PD/PI duties as needed. A multi-PI organizational structure is also acceptable if HUB PD/PI duties are equally shared and interchangeable.
Funding Information
NIDDK intends to commit $1,000,000 in FY 2025 to fund 1 award. It is expected that one award will be made contingent upon NIH appropriations and the submission of one or more meritorious applications.
NIDDK intends to fund one award.
The maximum amount to be awarded is $1,000,000 annually for five years.
93.847
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Ellen Leschek, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-8291
Email: LeschekE@extra.niddk.nih.gov
and Human Services (HHS)
