New England Journal of Medicine highlights TrialShare

We congratulate the Immune Tolerance Network (ITN) on ITN TrialShare’s debut in the New England Journal of Medicine (NEJM).  TrialShare has received recognition for how it provides public, interactive access to de-identified data, analyses and figures for published clinical trials, in this case ITN’s RAVE study, published in the NEJM on August 1.

An accompanying NEJM editorial (Participant-Level Data and the New Frontier in Trial Transparency) stresses the unusual openness of TrialShare:

“…the article by investigators from the Immune Tolerance Network (ITN) of the National Institute of Allergy and Infectious Diseases… is accompanied by open public access to participant-level data without the need for a specific research plan or approval of the qualifications of the investigators.”

Separately, a Nature Medicine article (Immunologist effort aims to improve hyperlinking of research papers to raw data) explores how TrialShare opens doors to data reuse and re-analysis:

“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 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.

The National Institute of Allergy and Infectious Diseases (NIAID) also comments on how TrialShare can support future discoveries:

“The website provides access to the study’s raw data and statistical analyses, allowing researchers to re-analyze the data and develop new hypotheses.”

In a world where simply providing access to de-identified data is a step forward for clinical trials, TrialShare’s support for live interaction with both data and analyses is exceptional.

For further details, see ITN’s commentary:  ITN Achieves Scientific Manuscript First – Provides Open, Interactive Access to Clinical Trial Data with New Publication: Rituximab Therapy Effective for ANCA-associated Vasculitis

ITN TrialShare is an installation of LabKey Server that was developed by the ITN in partnership with LabKey Software.