By Ann Neuer 

 

July 15, 2013 | Making sense of the millions of data points that characterize a clinical trials database is a tough challenge for sponsors in pursuit of new therapies. For therapeutic areas such as autoimmune disease, allergy and asthma, and transplantation, the Immune Tolerance Network (ITN), an international clinical research consortium, can help. Through TrialShare, a simple-to-use clinical trials research web portal developed at ITN, investigators and study management teams can better interpret data throughout the clinical trials process. 

 

TrialShare is part of ITN, a non-profit sponsored largely by the National Institute of Allergy and Infectious Diseases (NIAID) and funded by the National Institutes of Health. ITN has a mission to accelerate the clinical development of immune tolerance therapies through an interactive process with established investigators in academia and industry. Built using the open source LabKey Server framework, TrialShare provides open access to ITN’s clinical studies, its datasets, and bio-repository to the scientific community.

 

Adam Asare, Senior Director of Bioinformatics and the visionary behind TrialShare, explains ITN’s open access policy, “Being publicly funded, there is a big push to be transparent and provide public access to the datasets from our clinical trials. But clinical trial data can be very complex, so making them transparent to the public can be difficult. Through methodologies made available in TrialShare, this goal can be met. As part of this process, TrialShare allows researchers to reproduce and possibly expand our findings.” 

 

The process works by ITN soliciting proposals to answer the best scientific questions within its areas of focus. ITN collaborates mostly with the academic community across the globe, but also from the biopharmaceutical industry to co-sponsor clinical trials, most of which are Phase II. ITN then publishes the clinical data results in scholarly journals. “Through TrialShare, data and analysis code used in the manuscripts become interactive as users can click on links and see detailed descriptions of how the datasets were analyzed so they can re-run clinical analyses,” Asare says.

 

This ability to make data and analyses reproducible is one of the most significant values of TrialShare. According to research presented in Nature Genetics in 2009, reproducibility of gene signature biomarker data in published literature is iffy at best. Almost half the data cannot be reproduced for reasons such as data are not available, software is not available, or the methods are unclear. 

 

In the ten years since the launch of ITN, more than 1,000 clinical datasets have been released, with statistical code from six of its publications. Many of ITN’s clinical trials originate from solicited proposals utilizing specimens from ITN’s extensive biorepository of more than 270,000 de-identified samples maintained by ITN. These samples are linked to extensive laboratory assay results using flow cytometry, gene expression, and immunohistochemistry. Users can access assay and other clinical information about these samples through download. TrialShare also includes visualization tools that allow users to see the original analysis and then further interpret that information through user-defined filters. 

 

Accessing ITN TrialShare is simple. Interested users can visit www.itntrialshare.org and click on “Create an Account.”

 

“We had more than 30,000 page hits within the first few months of the launch of TrialShare. It’s proven successful because we understand how researchers would like to look at their data and make the best use of it,” Asare notes. 

 

For this work, ITN was awarded an Honorable Mention prize at the at the recent Bio-IT World Best Practices Awards held at the Bio-IT World Conference & Expo in Boston. Of the 34 projects evaluated, ITN received one of two honorable mentions for outstanding innovations and excellence in the use of technologies and novel business strategies that will advance biomedical and translational research, drug development, and/or clinical trials.