Learning to Share: Challenges in the Implementation of Data Sharing

• Activity Number: 385
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jonathan Hartzel*+
• Companies: Merck
• Keywords: data transparency ; de-identification ; data sharing

Abstract

Over the past year and a half, the clinical trial data transparency initiative has been evolving at breakneck speeds involving multiple stakeholders from regulatory agencies to industry to academic research centers. There are many benefits of data sharing including increased public trust in drug development and in the regulatory process, but the risk of re-identifying patient data must be carefully considered. This talk will focus on the experiences and challenges encountered at Merck while developing processes for sharing clinical data. Some topics will include the development of guidelines for minimizing the risk of re-identification of personal data, the challenges of automating de-identification in order to respond to data requests quickly, and the creation of data definition documentation for understanding the shared clinical data.