Statistical Graphics in Late Stage Drug Development

Abstract

Well-structured statistical graphics help us understand subject characteristics and behavior, and their relationships to efficacy and safety of study treatment. They are increasingly being used to extract and communicate information from the clinical trial data in a lucid and succinct manner. Rapid advancements have been made in recent years in statistical visualization techniques. Statistical software such as S-PLUS™ and R provide an extensive set of tools to construct graphics to aid in the interpretation and presentation of clinical data. In this chapter, several examples are presented to demonstrate the uniquely illuminating and enlightening roles of graphics in clinical trial data analysis. Some of these graphics have played significant roles in regulatory submissions and FDA advisory committee meetings.