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Immune Tolerance Network

ITN TrialShare

Developing a research web portal with the Immune Tolerance Network (ITN)

The Immune Tolerance Network (ITN) developed ITN TrialShare as a research web portal for both operational data management and post-publication sharing of data from clinical trials. The ITN is a multinational effort that encompasses over 100 investigators, over 40 phase I/II clinical trials, and over 100 sites.

ITN TrialShare is exceptional in how it serves as a public portal for de-identified data, annotations, analyses, and fully interactive figures from published clinical trials. In August 2013, ITN TrialShare broke new ground for clinical trial transparency by directly linking a major clinical trial publication to participant-level data and interactive analyses. Members of the public can use the portal to re-run and validate statistical analyses, interactively explore alternative hypotheses, and export data for external analysis. In July 2014, the National Academies named ITN TrialShare as the winner of the Data and Information Challenge. See: ITN TrialShare: Enabling True Clinical Trial Transparency.

Many of the data exploration tools available in ITN TrialShare are part of the core LabKey Server SDMS software; others involve leveraging the platform’s API, source code customization, and custom coding using the frameworks and languages supported by LabKey Server. ITN TrialShare also utilizes LabKey Server’s de-identification tools to de-identify participant-level data before public release to help ensure patient confidentiality. As of mid-2014, ITN TrialShare contained clinical and mechanistic assay data from 35 clinical trials, including 3,200 patients and 72,000 study visits.

Related Resources

2013 User Conference Presentation
ITN TrialShare Website

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