Metrics for Safety Assessment in Clinical Trials

• Activity Number: 350
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Ying Zhou*+ and Qi Jiang and Chunlei Ke and Seta Shahin and Steven Snapinn
• Companies: Amgen and Amgen and Amgen and Amgen and Amgen
• Keywords: clinical trials ; safety evaluation ; adverse event ; incidence rate ; absolute difference ; relative difference

Abstract

Safety evaluation is critical in clinical trials to protect patient safety and contribute to the benefit-risk assessment of the investigational drug. The challenges of safety data include unexpected/rare events, varying duration and severity, recurrent and multiple types, etc. In addition, there seems to be a lack of consistency, clear guidance and comprehensive recommendations on metrics for assessing safety data (i.e., absolute difference vs. relative difference). In this presentation, we review the common approaches to safety data analysis, and provide some recommendations on reporting and comparing safety data in clinical trials.