Notice of Intent to Publish a Funding Opportunity Announcement for Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required)

Key Dates

None

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 Coordinating Center (TNCC). The TrialNet network identifies people with type 1 diabetes (T1D) at stages before and after onset of clinical symptoms and enrolls them in trials and studies aimed at prevention of progression to clinical disease and preservation of insulin production. The TNCC participates in ongoing studies and intervention trials as well as the design and conduct of new studies and intervention trials. The TNCC will: (1) support a wide range of research projects in varying stages of development, implementation and completion, and (2) provide data and sample management, including standardized acquisition, quality control, dissemination and public accessibility. The TNCC will be responsible for network administration and operations, including the evaluation, selection, and funding (through subcontracts) of Clinical Centers and central support units (such as laboratories) necessary for the conduct of TrialNet’s clinical studies. The TNCC PD/PI will be a voting member of the TrialNet Executive and Steering Committees, contributing to network leadership. 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 Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.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 research in the prevention of type 1 diabetes (T1D) to begin to consider applying for this new NOFO.

During this project period, TrialNet will continue its ongoing prevention and new-onset trials. In addition, TrialNet will plan and prioritize new prevention and new-onset trials and studies. 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 plan for and perform mechanistic studies in conjunction with trials as well as provide access to samples and participants from TrialNet clinical studies. This will generate information to improve understanding of the pathophysiology of T1D and to identify biomarkers to serve as intermediate study endpoints, enabling intervention earlier in the disease process, shorter trials using fewer participants, and the potential for interventions tailored for specific pathogenic mechanisms.

In accordance with the Regulatory Policies and Guidance under NIDDK Policies for Clinical Researchers, which defines the roles and responsibilities of the TNCC (https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers), the TNCC is responsible for:

• oversight and coordination of Clinical Center activities, including supporting development of the Clinical Centers and implementing studies and trials conducted by the network of Clinical Centers and Affiliates Sites;
• oversight of implementation of and adherence to protocols;
• coordination of communication among and with the Clinical Centers and Affiliate Sites;
• management of the collection and analysis of genetic, immunologic, pathogenic, clinical and biological samples and data from the clinical sites;
• training and certification of staff, and maintenance and updates of the Manuals of Operations for each TrialNet trial;
• maintaining the TrialNet internal and public websites in collaboration with the HUB;
• organizing and preparing reports for TrialNet SC meetings, Data Safety Monitoring Board (DSMB) meetings, External Evaluation Panel (EEP) meetings, and other meetings and workshops as necessary;
• collection and management of all clinical and laboratory data, and for ensuring subject confidentiality, safety and quality control;
• ensuring that the design of studies and trials, including their primary outcomes, are scientifically sound and are supported by appropriate statistical evaluations;
• providing biostatistical and analytic expertise and conducting data analysis and interpretation (in conjunction with the TrialNet network investigators) of the data generated by TrialNet studies;
• guiding development of the statistical analysis plan for each TrialNet study or trial as a whole and for each manuscript reporting pre-specified primary and secondary outcomes;
• overseeing and facilitating communication between the Drug Distribution Center and the Clinical Centers (and Affiliate Sites) to ensure the timely supply of trial drug according to the protocols;
• transferring all data and biosamples generated by TrialNet to the NIDDK Central Repository per NIH and NIDDK Resource Sharing policies;
• engaging a broader set of investigators external to the immediate TrialNet group to provide opportunities to analyze data and participate by means of ancillary studies;
• developing opportunities for local analysis of data by TrialNet investigators and other qualified researchers at their institutions, and investigators outside the TrialNet group ("disseminated data analysis"); and
• abiding by the network Duality of Interest Policies and Procedures and implementing procedures requiring TrialNet investigators and others to identify financial and other conflicts of interest on a routine basis, at least annually, and share this information with NIDDK.

The TNCC will engage independent peer reviewers to help select Clinical Centers to screen the relatives of people with T1D and enroll those eligible and interested into TrialNet prevention and new-onset studies.

• Clinical Centers will be represented as voting members on the TrialNet SC, which evaluates and approves every TrialNet study.
• Some, but not all, Clinical Centers will oversee Affiliate Sites, and Clinical Center/Affiliate Site distribution will be organized to optimize coverage of North America.
• Successful Clinical Center applicants will demonstrate the ability to efficiently screen, recruit, treat and follow subjects in T1D prevention trials and should incorporate active and innovative approaches to improving screening and enhancing trial participation.
• Clinical Center Program Directors/Principal Investigators (PDs/PIs) are expected to participate as members of the TrialNet SC as well as on TrialNet’s operational committees (individual trial committees, manuscript committees, clinical operations committees, laboratory monitoring committee, ancillary studies committee, etc.).
• Clinical Center PDs/PIs should have expertise in T1D etiology and pathogenesis as well as the willingness to engage in potentially challenging but scientifically strong interventions and studies that advance the field toward its goal of T1D prevention.
• Clinical Centers will be chosen based on their ability to screen and recruit trial participants and implement study protocols.
• Only applications from North American institutions will be considered, and all U.S. sites must be willing and able to utilize TrialNet's central IRB (OneIRB).
• Clinical Centers must propose at least one Coordinator at no less than 6 person-months devoted exclusively to TrialNet, and total PD/PI effort at each Clinical Center must not exceed 3.6 person-months.
• Funding levels for selected Clinical Centers will be re-evaluated yearly based on individual site productivity and available opportunities.
• Funded Clinical Centers must demonstrate their intention to actively participate in all TrialNet prevention trials and should participate, when possible, in ancillary studies and partnered new-onset trials.
• Geographic distribution of network centers should be considered in the choice of Clinical Centers to ease subject burden and reduce network costs related to travel.

Funding Information

Public/State Controlled Institution of Higher Education
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: [email protected]