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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC