This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 330
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306817
Title: Real-Time Safety Assessment: A Sponsor's Approach on Tool Development to Facilitate the Assessment
Author(s): Christy Chuang-Stein*+ and Craig Hartford and David M. Jones and Janice Lamb
Companies: Pfizer Inc. and Pfizer Inc. and Pfizer Inc. and Pfizer Inc.
Address: 5857 Stoney Brook Rd, Kalamazoo, MI, 49009,
Keywords: Real-time safety assessment ; Self-serve solution ; Tool development
Abstract:

It is essential that we protect subject safety in clinical studies by reviewing incoming safety data promptly. This responsibility typically rests with the investigators/clinical team. For double-blinded trials, a Data Monitoring Committee is often convened to regularly review by-group safety summaries. Even so, the clinical team should review safety data to proactively identify safety signals and bring potential concerns to the Committee for resolution. Unfortunately, such efforts can be hampered by inadequate data review tools. In this presentation, we describe how a multidisciplinary group at Pfizer collaborated to find a self-serve solution to tools. We will share the story of how we evolved from requests for data, to self-serve reports of tables/listings and onto self-serve graphics solutions. Besides productivity, such tools contribute to enhancing pharmacovigilance compliance.


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