The Immune Tolerance Network’s (ITN) TrialShare Clinical Trials Research Portal (www.ITNTrialShare.org) has won the National Academy of Sciences Data and Information Challenge. The theme of this year’s competition, launched and judged by the academy’s Board on Research Data and Information (BDRI), was “Using Data for the Public Good.”
The ITN’s entry, entitled “ITN TrialShare: Enabling True Clinical Trial Transparency” describes the unique data sharing portal developed by the NIH-sponsored clinical research consortium. The system provides clinical trial investigators an unprecedented ability to share data with other researchers. Among its unique features are the ability to access raw de-identified participant level study data, review published analysis methods, and perform real-time interactive graphical analyses in collaboration with other researchers.
The BRDI Data and Information Challenge was created by the National Academy of Sciences as a means of increasing awareness of current issues surrounding the collection and use of scientific research data, including accessibility, integration, and reproducibility; as well as promoting new opportunities for novel analyses, allowing for maximum societal benefit from the available data.
With a number of high profile drug failures in the past decade, there is a growing movement within government, industry, and academia for greater transparency in the reporting of clinical trial results. Substantial progress has been made in reaching consensus on the need for change; however a number of technical and procedural challenges have limited the ability to implement effective solutions. ITN TrialShare has been created to specifically address many of these issues.
“Modern clinical trial data is highly complex, often including information related to genetic testing and other high throughput techniques that generate a lot of data,” says Adam Asare, ITN Director of Bioinformatics. “What we’ve done is create a set of intuitive tools that allow researchers to share and analyze their data in multiple ways – you can be an expert statistician or a novice, and find what you need.”
Anyone with a valid email address can self-create a free ITN TrialShare account in minutes and start accessing hundreds of datasets for dozens of completed studies, data and analyses. ITN TrialShare currently has data and specimen bio-repository information associated with 35 trials and 3,200 participants available to the public in the therapeutic areas of transplant, allergy, autoimmunity, and type I diabetes. ITN makes the underlying data from all published and closed studies, regardless of outcome, available through TrialShare. ITN TrialShare was built and customized using the LabKey Server (www.labkey.org) open source framework.