Researchers

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 current clinical trials is here  or visit Our Research.

A list of our previously conducted clinical trials is here 

Please contact Sarah Muller if you have questions.

Ideas for Mechanistic Studies

TrialNet’s mechanistic portfolio includes studies using samples from previous and ongoing clinical trials including our Pathway to Prevention Study (TN01), and Long-term Investigational Follow-up in TrialNet (LIFT) Study (TN16).

TrialNet samples constitute a precious resource that has been made widely available to investigators.  To date, almost 100 ancillary studies have been approved and more than 25,000 samples from 7,800 participants have been provided to investigators within and external to TrialNet.   After comprehensive review of these studies and following recommendations from external investigators, we identified gaps and opportunities to advance TrialNet’s scientific priorities.   This strategic review has resulted in a revised model for mechanistic studies.  Going forward, mechanistic studies will be considered an integral part of TrialNet and no longer considered “ancillary” to our activities.

Investigators are invited to work with TrialNet to advance our priorities as described below.  Additionally, TrialNet will continue to draw on external scientific expertise to provide ideas, guidance, and advice about our mechanistic portfolio.

Contact Sarah Muller for questions or to express interest in collaborating with TrialNet on mechanistic studies.

1. Key Questions Studies:  These are TrialNet developed, major research questions with identified populations and samples for which multiple technologies and assays will be applied and multidimensional analysis used.  Investigators are encouraged to suggest platforms, technologies, and assays that could be applied to these questions.  It is expected that there will be periodic RFAs for academic and/or industry investigators interested in conducting specific assays for each targeted question. 

The Key Questions are available at TrialNet Key Questions.pdf

2. Stored Sample Concept Proposals: TrialNet welcomes investigators who have ideas for studies using TrialNet stored samples.  Previously, these ideas were reviewed and considered as ancillary studies.  These requests will now only be considered as collaborative efforts with TrialNet.

Concept proposals for the use of stored samples will be reviewed according to TrialNet’s priorities as defined.  Investigators are urged to read this document before submitting a proposal, as only those concept proposals identified as being of high priority and outstanding scientific interest will be pursued.  This will be done through incorporating the proposed assay into one of our existing key questions studies or through collaborative development of a TrialNet mechanistic study.

The stored sample concept proposal application is available here.

3. Exploratory Assays Living Biobank Proposals: TrialNet also 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.

4. Data Integration and Collaborations: TrialNet has approved ~100 ancillary study applications from investigators within and external to TrialNet.  TrialNet has provided investigators with 25,000 samples from 7,800 subjects.  As such there is a wealth of information from work already done addressing important questions.  TrialNet is interested in new collaborations that seek to analyze and integrate data across studies including data obtained from existing ancillary studies.  This will provide added value to TrialNet, its collaborators, and the T1D research community.

A searchable database of previous mechanistic studies performed as ancillary studies can be accessed here. Investigators interested in joining these efforts should contact David Skibinksi who is leading TrialNet’s efforts in this area.

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, trialnetpublications@epi.usf.edu, before submitting an application to the publications committee.

The application for data access, analysis and proposed publication is coming soon. 

Investigators are also encouraged to access the NIDDK data-repository website.  Data from TrialNet studies is available directly through that resource. 

TrialNet Studies

Study Name Enrollment Status Sort descending Description
Oral Insulin Prevention Study Completed TrialNet tested the drug Oral Insulin to see if it can delay or prevent T1D (stage 1) from progressing to stage 2 and ultimately prevent clinical diagnosis (stage 3).
Teplizumab Prevention Study Completed We tested the drug teplizumab to see if it could delay or prevent progression of early stage T1D (stage 2) and prevent clinical diagnosis (stage 3). In earlier studies in people newly diagnosed (stage 3), teplizumab helped to prolong insulin production.
ATG/GCSF New Onset Study Completed ATG/GCSF was designed to build on prior findings of a pilot study suggesting thymoglobulin (ATG) combined with pegylated granulocyte colony stimulating factor (GCSF) preserved insulin production for more than 1 year after treatment in people who had type 1 diabetes for 4 months to 2 years.
Hydroxychloroquine (HCQ) Currently Enrolling We are testing the drug hydroxychloroquine (HCQ) to see if it can delay or prevent early stage T1D (stage 1) from progressing to abnormal glucose tolerance (stage 2) and ultimately prevent clinical diagnosis (stage 3). HCQ is already used to reduce symptoms and progression of other autoimmune diseases, such as rheumatoid arthritis and lupus. This is the first study to see if it can prevent or delay T1D.
Long-Term Investigative Follow-Up in TrialNet (LIFT) Currently Enrolling If you are diagnosed with T1D while participating in one of our prevention studies, we’re still here for you. You can continue to receive personal monitoring while helping us learn more.
Monitoring Currently Enrolling Depending on your risk screening results, you may be eligible for monitoring. We’ll monitor you for disease progression and let you know if you become eligible for a study.
Pathway to Prevention Currently Enrolling If you have a relative with T1D, you may be eligible for risk screening that can detect the early stages of T1D years before symptoms appear.
Abatacept Prevention Study Currently Not Enrolling TrialNet is testing the drug abatacept to see if it can delay or prevent progression of early stage T1D (stage 1 or stage 2), and ultimately prevent clinical diagnosis (stage 3). In earlier studies for people newly diagnosed (stage 3), abatacept helped slow down disease progression.