Access to Patient-Level Data from GlaxoSmithKline Clinical Trials

Abstract

Efforts are under way to increase the transparency of clinical trial data. Among the efforts are those being undertaken at GlaxoSmithKline, where we have recently made a commitment to provide access to deidentified patient-level data. We are taking this step because it is the right thing to do, both scientifically and for society, and it is in line with our company's commitment to transparency in clinical trial reporting. As of May 2013, investigators are able to request access to deidentified patient-level data from a subset of GlaxoSmithKline-sponsored clinical trials. We expect that research teams requesting data will have sufficient statistical and data-management expertise to evaluate these data sets, and we call for standards in analysis to be defined by the scientific community. This article describes the approach we are adopting and answers some of the most common questions we have received since our announcement of this policy.