Clinical Study Patient-Level Data Sharing: The GSK Experience to Date

• Activity Number: 385
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Amit Bhattacharyya*+ and Paul McSorley
• Companies: GlaxoSmithKline and GlaxoSmithKline
• Keywords: data transparency ; clinical trial data ; anonymized data

Abstract

The past few years have seen an increased demand for access to patient-level clinical trials data from regulators and a wide range of others including scientific Journals and researchers across the medical community. To meet this demand for access to anonymized clinical trials data, and to develop and build trust with patients and society at large, a handful of drug sponsors have begun to share data , with GSK taking a lead role in implementing a process for sharing anonymized patient-level trial data. In this presentation, we plan to share the GSK experience to-date. This will include (a) the challenges that drug sponsors like GSK face with respect to balancing patient privacy, our commitment to the patients via the Informed Consent Form, and the desire to share the anonymized data externally; and (b) the data-sharing practices that GSK has initiated to allow qualified independent researchers to gain access to patient-level data to corroborate already-reported results and pursue new analyses.