Advances in Biopharmaceutical Statistical Science Applied to Safety During Dr. O'Neill's Tenure

• Activity Number: 465
• Type: Invited
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Statistics in Biopharmaceutical Research Journal
• Author(s): Frank W. Rockhold*+
• Companies: GlaxoSmithKline
• Keywords: Patient Safety ; FDA ; Post Marketing Safety

Abstract

In the past 10-15 years many advances have been made in the analysis and inference related to both pre and post marketing safety data. This has also led to greater visibility and transparency around the evaluation of the safety of new medicines. While many researchers have been involved in this evolution, Bob O'Neill stands out as someone has championed this transformation longer and more loudly than anyone. For more than 25 years Bob has urged industry statisticians to shed their clinical trial shackles long enough to think more broadly about the less structured, but impactful data around patient safety and by extension what gets communicated to the health care practitioner and the patient in labeling. He encouraged us to push our safety colleagues to be more disciplined and structured around the design, collection and interpretation of data related to safety. This talk will review some of the advances made in the evaluation of safety data during the last few decades and highlight those either directly attributable to Bob or at a minimum motivated by his consistent focus on this topic. Through his efforts public health and patient safety have been advanced.