title: Opening clinical trial data: are the voluntary data-sharing portals enough?
abstract: Data generated by the numerous clinical trials conducted annually worldwide have the potential to be extremely beneficial to the scientific and patient communities. This potential is well recognized and efforts are being made to encourage the release of raw patient-level data from these trials to the public. The issue of sharing clinical trial data has recently gained attention, with many agreeing that this type of data should be made available for research in a timely manner. The availability of clinical trial data is most important for study reproducibility, meta-analyses, and improvement of study design. There is much discussion in the community over key data sharing issues, including the risks this practice holds. However, one aspect that remains to be adequately addressed is that of the accessibility, quality, and usability of the data being shared. Herein, experiences with the two current major platforms used to store and disseminate clinical trial data are described, discussing the issues encountered and suggesting possible solutions.
authors.affiliation: Institute for Computational Health Sciences, University of California San Francisco, Mission Hall, 550 16th Street, 4th Floor, San Francisco, CA, 94158-2549, USA.
authors.forename: Nophar
authors.initials: N
authors.lastname: Geifman
authors.affiliation: Sean N. Parker Center for Allergy Research, Department of Pediatrics, Division of Allergy, Immunology & Rheumatology, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Bollyky
authors.affiliation: Institute for Computational Health Sciences, University of California San Francisco, Mission Hall, 550 16th Street, 4th Floor, San Francisco, CA, 94158-2549, USA.
authors.forename: Sanchita
authors.initials: S
authors.lastname: Bhattacharya
authors.affiliation: Institute for Computational Health Sciences, University of California San Francisco, Mission Hall, 550 16th Street, 4th Floor, San Francisco, CA, 94158-2549, USA. atul.butte@ucsf.edu.
authors.forename: Atul J
authors.initials: AJ
authors.lastname: Butte
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D012107:Research Design