A study published today in the New England Journal of Medicine reports that people suffering from ANCA-associated vasculitis, a disease in which the body attacks its own defense system, can now be effectively treated with one month of weekly infusions of rituximab, instead of the standard 18-month regimen with daily pills of cyclophosphamide, which has strong side effects. But that is not the only thing that makes the report noteworthy. According to its authors, the study is the first to contain hyperlinked charts or graphs that redirect users to an information-sharing system called TrialShare, where they can instantly access data amassed during this clinical trial and others.
The interactive platform was developed by the Immune Tolerance Network (ITN), a consortium of clinical researchers who study everything from allergies to organ transplants. The ITN is headquartered in Seattle, Washington, and funded by the US National Institute of Allergy and Infectious Disease, in Bethesda, Maryland.
Even without an online version of the article, anyone can sign on to the website, at www.itnTrialShare.org. However, the site is geared toward researchers who want access to information acquired during a study—for example, the twice daily blood pressure readings of patients that a researcher might have reported as an average instead of logging every measurement—which may not have made it into the published paper or supplementary material. Creators of the website emphasize that the information about the patients is anonymized.
This isn’t the first effort to put more information about clinical trials in the hands—and minds—of more people, with the hope of improving the design of future studies and avoiding redundant work. There are some groups, such as the Biomarkers Consortium, based in Bethesda, Maryland, and founded by a combination of private and public agencies that include the US National Institutes of Health (NIH), focused on specific collaborations that only share research data only among their partnership members. TrialShare, by comparison, is now open-access.
Other databases, such as the Gene Expression Omnibus (GEO) run by the NIH’s National Center for Biotechnology Information, act as repositories for data, but they lack the clinical data seen in the TrialShare site.
The creators of the TrialShare web portal hope that scientists drawn to the site after reading published papers that reference it will experiment with the data available there to test new hypotheses. The site, which has been available to ITN members since last October, also makes it possible to search through related publications or request biopsies that may still be available from a particular study. “By making a wealth of data available, we’re hoping to leverage the expertise of other researchers to learn more,” says Laurence Turka, a transplant immunologist at the Massachusetts General Hospital, in Boston, Massachusetts, and a deputy director at the ITN.
One drawback to TrialShare, however, might be that studies are only drawn from research of ITN members. “It might be ideal to have everything under one roof,” says Turka. “But that would mean using one system and that might not be the best way for everyone to present their data.”
There are initiatives underway to provide greater access to data from a wider array of published results of clinical trials. The Institute of Medicine, of the US National Academies in Washington DC, held a workshop last October to assess the benefits and challenges of data sharing culminating in a summary report calling for further study of models that make such data more accessible.
“The ITN effort is part of a big transformation that’s just beginning in clinical trials reporting,” says Deborah Zarin, director of ClinicalTrials.gov, a database of research summaries administered through NIH. “It’s part of a continuum of strategies to make more participant-level information available and we should learn from each of them.”