Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights

• Activity Number: 108 - New Era for Safety Evaluation
• Type: Topic Contributed
• Date/Time: Monday, July 30, 2018 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Olga Marchenko*
• Companies: Bayer
• Keywords: Adverse events; Safety assessment; Real World Data

Abstract

In this presentation, different sources of safety data will be briefly reviewed and selected statistical strategies and methods for analyzing safety data from various stages of drug development, post-marketing safety surveillance, and real world will be presented. Additionally, strategies on how to use the totality of information to generate evidence will be discussed.