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Clinical Trial Transparency
Session Chair(s)
Egbert Biesheuvel
Head of early stage statistics
Merck Sharp & Dohme, Netherlands
Rebecca Sudlow, MS
Global Lead Patient Level Data Sharing
Roche, United Kingdom
There is a significant change coming to Europe regarding access to patient level data. EMA has decided to make individual patients' data from clinical trials available to third parties beginning January 1st, 2014. This session will present the ongoing rapid developments in this area from academic, regulatory and industry perspectives. It will touch upon key topics like ensuring patient confidentiality, data formats and transparency of requests and scientific purpose and will highlight the importance to the EU statistical community.
Speaker(s)
Statistical aspects of EMA’s Clinical Trial Data Transparency Initiative
Christoph Gerlinger, MSc
Bayer Pharma AG, Germany
Senior Director, Statistics
A View from Outside Industry
Tony Johnson
The MRC Clinical Trials Unit , United Kingdom
Clinical Trial Data: Open For All? EMA’s Perspective
Frank Petavy, MS
European Medicines Agency, Netherlands
Head of Methodology
Access to Anonymised Patient Level Data from GSK Clinical Trials
Sara Hughes
GlaxoSmithKline, United States
Senior Vice President, Biostatistics
Data Transparency: Crystal Clear or Still A Little Foggy
Kevin Carroll
United Kingdom
Expert Statistician; Honorary Senior Lecturer
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