Clinical trial data access: Opening doors with TrialShare.

The need for improved access to clinical trial data is widely recognized to ensure complete information is in the public domain, to honor the commitment of research subjects, and to empower and engage analytic talent across the worldwide biomedical community. Open access to patient-level data from clinical trials enables data transparency, fosters data sharing, and catalyzes research innovation. As noted by Ross andKrumholzm ‘‘A wall surrounds much. clinical research data, sequestering knowledge, impeding the free flow of information, and obscuring a clear view of the totality of evidence relevant to many research questions and clinical decisions.’’ Mello et al stress the benefits of data transparency, which range from improving reporting accuracy to improving patient safety, as well as speeding innovation. Long-term benefits of data sharing include improvements in future clinical trial design, generation of new research hypotheses and research grant applications, and identification of targets for future drug development. Indeed, the National Institute on Drug Abuse Treatment Clinical Trials Network Data Share Project recently documented 13 published examples of secondary use of public data sets fromNational Institute onDrugAbuse–sponsored clinical trials, illustrating the potential to promote additional research and new insights from completed studies. Immune Tolerance Network (ITN) TrialShare, a novel portal for viewing and analyzing complete data sets from ITN trials, demonstrates this commitment through open access and userfriendly analytic tools. ITN TrialShare integrates data display from laboratory outputs, biomarker outcomes, and clinical and demographic attributes across a wide range of immunologic diseases and interventions, including the recent Learning Early About Peanut Allergy (LEAP) and LEAP-ON studies. This has