A research consortium sponsored by the US National Institute of Allergy and Infectious Diseases has launched an online portal providing open access to raw data from the consortium’s publicly funded clinical trials of immune-tolerance therapies.
The Immune Tolerance Network (ITN) is debuting its TrialShare portal in conjunction with the publication in the New England Journal of Medicine of 18-month results from the Network’s RAVE trial of the B-cell depleting agent rituximab in Wegener’s Granulomatosis and Microscopic Polyangiitis.
The ITN is giving researchers who register with TrialShare “unfettered” access to the underlying clinical data and analysis code for the RAVE trial, as well as providing data-analysis tools that will allow investigators to confirm the published results and conduct independent analyses.
TrialShare is also a gateway to the Network’s specimen repository catalogue, enabling users not involved in the original trial to request specimens for follow-up experiments based on the data and available samples.
With the addition of the RAVE 18-month results, TrialShare now offers data associated with six published manuscripts in the areas of transplant, allergy, auto-immunity and diabetes.
ITN says it will make the underlying data from all of its published studies available through TrialShare, regardless of outcome.
These are de-identified patient-level data that include, for example, longitudinal views of individual and user-defined groups, pathology images, gene expression data and visit histories.
“I think that this effort will help change the way scientific and clinical data are disseminated (while maintaining the integrity of the peer-review process) and help the biomedical community respond to the increasing demand for access to data from publically funded clinical trials,” commented Philip Bernstein, the ITN’s executive director, strategic review, planning & communications.
As the Network pointed out, the US Food and Drug Administration is considering making de-identified and masked subject-level clinical data widely available to improve the efficiency and effectiveness of medical product development.
“ITN TrialShare was created precisely to address this need, enabling researchers to share the results of the clinical-trial data in an open and transparent manner, while protecting the privacy and anonymity of study participants by fully de-identifying the data,” it added.
The new research portal can be found online at www.itntrialshare.org.