TrialNet welcomes the engagement of academic investigators and industry to share ideas and knowledge in order to advance our mission of bringing disease modifying therapy to clinical use.
Ideas for Clinical Trials
TrialNet is eager to consider novel agents, combinations and study designs that help advance our mission. We accept suggestions for clinical studies, including proof of mechanism, pilot studies, and Phase 1 thru 3 trials.
TrialNet is primarily interested in receiving ideas for drugs that can be used in clinical trials to modify disease course prior to clinical onset. Studies in new-onset disease will also be considered, providing they are a key component of the pathway towards a prevention study (e.g. provide PoC, safety, etc.).
The clinical trial concept proposal application is here.
A list of our previously conducted clinical trials is here
Please contact Sarah Muller if you have questions.
Important information for investigators regarding samples and data from TrialNet
TrialNet has a repository of samples from multiple intervention trials and from two observational studies aimed to understand the natural history of T1D and the response to therapy. Many of these samples were provided to individual investigators to address specific high priority scientific questions. This led to a number of important observations (reviewed in Battaglia, et al., Diabetologia, 2017). The precious nature of the remaining samples in our inventory has necessitated a change in our approach. To fully take advantage of this unique collection of samples from our well-characterized study subjects, sample release will now be part of a broad-based and collaborative team effort involving investigators within and external to TrialNet.
As a framework for collaboration, TrialNet is creating Key Questions to prioritize using samples and data from our studies to understand the natural history of T1D progression. Please note that TrialNet is unlikely to release samples from at-risk individuals that can be addressed using data from Key Question studies using samples from observational studies. Thus, before submitting a proposal, please review the information below. Similarly, if you are interested in samples from our clinical trials, we have a detailed and prioritized mechanistic plan for sample use. Please contact Sarah Muller or Peter Gottlieb to learn more about plan details.
The Collaborative Mechanistic Studies Panel (CMSP) is coordinating the Key Question process and invites other investigators to work with us. The first Key Question is described below. We are planning to undertake further Key Question studies including progression from 1 to 2 autoantibodies, addressing why subjects in our intervention trials fail immunotherapy, etc. New questions are welcome. Please contact Sarah Muller or Peter Gottlieb with suggestions.
Key Question 1: How to understand immune markers that predict or are associated with disease progression. (This is an ongoing study. Our goal is to make the initial data set available to the research community in 2021.)
- This is a retrospective case: control study involving longitudinal samples from antibody positive individuals who developed T1D within 3 years (n = 89) and antibody positive individuals who did not progress during that time matched for key characteristics such as age (n = 89). A total of 556 samples are being tested in Drs. Eoin McKinney, Adeeb Rahman and Dirk Homann’s laboratories.
- The McKinney lab is performing bulk RNA-Seq on PBMC samples sorted into the following immune cell subsets: memory CD4+ T-cells, memory CD8+ T-cells, memory B-cells, Tregs, monocytes, NK cells, plasmablasts, cDCs, pDCs and bulk PBMCs.
- Data from the memory CD4+ and CD8+ T-cell subsets will be available in the study’s initial data release.
- The Rahman lab is performing high dimensional mass cytometry (CyTOF) to extensively phenotype PBMCs using three separate panels each consisting of >35 markers.
- The complete data set will be available in the study’s initial data release.
Several analytical approaches to evaluate the study data are planned.
If you wish to submit a proposal for use of TrialNet samples, please complete a Stored Sample Concept Proposal application here.
Exploratory Assays Living Biobank Proposals
TrialNet welcomes investigators who have mechanistic study proposals involving fresh blood samples from one, or at most a few, TrialNet sites. All such “living biobank” studies must have the concurrence of the clinical site PIs and must not require other support from TrialNet. This mechanism is most appropriate for more exploratory studies.
These proposals will be reviewed according to TrialNet priorities and to evaluate impact on subject and site burden (i.e. blood volume and shipping/handling requirements). Studies that involve very low impact on subjects and centers (e.g., involving a single center) are frequently approved.
The Exploratory Assays Living Biobank application is available here.
Analysis and Publication of Existing Data
TrialNet’s publication committee welcomes ideas for analysis and publication of existing TrialNet data. Link to TrialNet publications here, access the NIDDK data-repository, and apply for data access.
Investigators are encouraged to discuss ideas with TrialNet Publication Committee, email@example.com, before submitting an application to the publications committee.
The application for data access, analysis and proposed publication is coming soon.