Communicating Clinical Trial Results the Statistical Graphic Way

• Activity Number: 322
• Type: Invited
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Committee on Applied Statisticians
• Author(s): Mat Soukup*+
• Companies: FDA
• Keywords: graphics ; clinical trials ; regulatory

Abstract

Within a regulatory setting, it is important to communicate findings observed in clinical trials to our clinical colleagues in addition to our statistical brethren. Findings may be in terms of potential safety signals, highlights of key efficacy findings, or even summaries of patient discourse. The key is that compelling statistical graphics can provide transparent representations of the data collected in clinical trials which thereby improve our ability to make sound decisions on the safety and efficacy of drug products. In this presentation, we will present various graphical approaches that characterize the data in ways which are all-important in making regulatory decisions.