JSM Preliminary Online Program
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Activity Number: 120
Type: Invited
Date/Time: Monday, August 7, 2006 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistical Graphics
Abstract - #305338
Title: Statistical Graphics: Applications in Drug Discovery and Clinical Development
Author(s): C. George Rochester*+ and Charles K. Cooper and Mat Soukup and Ana Szarfman and Robert T. O'Neill
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: Building 22, Room 5235, Silver Spring, MD, 20903,
Keywords:
Abstract:

Recent issues with drug safety have resulted in sensitivity to analysis and reporting of safety data in clinical studies, as well as new guidance's for trial sponsors in this regard. As a result, more information has to be comprehended by and communicated among investigators, collaborators, institutional review boards, data safety management boards, and the FDA. This talk will review modern visualization methods for analysis, reporting, and regulatory review of safety data and provide suggestions for standard graphical analyses. Interactivity in the use of modern graphical displays and its value to further data exploration and analysis also will be incorporated. Examples from pre-marketing and postmarketing data will be included.

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Revised April, 2006