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Activity Number: 4 - Safety Evaluation, Data Sources, and Statistical Strategies: Transforming Information into Evidence
Type: Invited
Date/Time: Sunday, July 30, 2017 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract #321967 View Presentation
Title: Transforming Real World Data into Evidence
Author(s): Estelle Russek-Cohen and Mark Levenson and Qi Jiang and Richard C. Zink and Michelle Krukas and Olga Marchenko*
Companies: U.S. Food and Drug Administration and FDA and Amgen Inc. and JMP Life Sciences, SAS Institute, Inc. and QuintilesIMS and QuintilesIMS
Keywords: safety ; real world data ; registry ; EMR ; sources of data ; decision making
Abstract:

What are the different sources of data that can be used to supplement clinical trials and facilitate more informed decision making? How can one gather the necessary safety information without adding too much to drug development cost and delaying the process of taking an effective medicine to a patient? In this presentation different sources of safety data and ideas on how to use the totality of information to generate evidence will be discussed. Case studies that used real world data successfully to generate evidence will be presented.


Authors who are presenting talks have a * after their name.

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