Understanding Patient Safety Through Use of Statistical Graphics

Presented: Wednesday, July 11, 2007

Speaker: Ohad Amit, GlaxoSmithKline

• Listen to the on-demand web cast . Download instructions on how to view the web cast.
• Download the web cast presentation.

This web cast referenced our recent session #253 at DIA on Graphical Analysis of Clinical Safety and Efficacy Data. Download presentations from the DIA event by clicking on the links below.

• Statistical Graphics for Clinical Development Studies
  Michael O’Connell, PhD, Director, Life Sciences, Insightful Corporation
• Visual Representations of Clinical Data during the NDA Review Cycle
  Mat Soukup, PhD, FDA

Abstract: Patient safety has always been a primary focus in the development of new pharmaceutical products. The predominant method for statistical evaluation and interpretation of safety data collected in a clinical trial is based on the use of descriptive statistics generally displayed in tabular form. However, in many instances a full understanding of the safety profile for a particular compound requires an insight as to what is happening at the individual patient level. There is a great opportunity to enhance evaluation of drug safety through the use of graphical displays, which can convey multiple pieces of information concisely and more effectively than can tables. Graphs can be used in an exploratory setting to help identify emerging safety signals.  They can also be used in a confirmatory setting in order to explain and further elucidate issues around safety endpoints that have been prospectively identified. We provide several graphical displays for routine safety data collected during the course of a clinical trial, covering a broad range of graphical techniques. Several of the graphical displays facilitate an understanding of the safety data at an individual patient level.