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Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach
Author(s) -
Hughes Sara,
Wells Karen,
McSorley Paul,
Freeman Andrew
Publication year - 2014
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.1615
Subject(s) - confidentiality , data sharing , clinical trial , patient data , internet privacy , medical research , data anonymization , computer science , patient privacy , data access , patient confidentiality , information privacy , data science , medicine , health care , computer security , alternative medicine , political science , pathology , law , programming language
In May 2013, GlaxoSmithKline (980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) established a new online system to enable scientific researchers to request access to anonymised patient level clinical trial data. Providing access to individual patient data collected in clinical trials enables conduct of further research that may help advance medical science or improve patient care. In turn, this helps ensure that the data provided by research participants are used to maximum effect in the creation of new knowledge and understanding. However, when providing access to individual patient data, maintaining the privacy and confidentiality of research participants is critical. This article describes the approach we have taken to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants, ensures compliance with current data privacy legal requirements and yet retains utility of the anonymised datasets for research purposes. We recognise that there are different possible approaches and that broad consensus is needed. Copyright © 2014 John Wiley & Sons, Ltd.