Communicating Clinical Trial Results: An FDA Statistical Reviewer’s Perspective
*Mat Soukup, U.S. Food and Drug Administration 

Keywords: graphics, safety, efficacy

Increasing concerns for drug safety and the lengthy drug development process have highlighted the need for efficient, thorough and transparent statistical data analysis and reporting of clinical studies. The use of compelling statistical graphics can provide transparent representations of the data collected in clinical trials. Such presentations improve the quality of clinical decisions, increase the likelihood of discerning safety and efficacy signals, and enable more productive interactions between the U.S. FDA and regulated companies. In this presentation, we will discuss graphical displays that improve upon traditional methods for the tabular reporting of clinical trial results, as well as examples that have been critical in making regulatory decisions.