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Activity Number: 493 - Leveraging Historical Data and Real World Evidence in Drug Development Program Evaluation
Type: Topic Contributed
Date/Time: Wednesday, July 31, 2019 : 10:30 AM to 12:20 PM
Sponsor: Health Policy Statistics Section
Abstract #305040 Presentation
Title: Sources of Data and Statistical Strategies for Design and Analysis: Real World Insights
Author(s): Olga Marchenko*
Companies: Bayer

In this presentation, different sources of safety and efficacy data will be briefly reviewed and selected statistical strategies and methods for analyzing safety data from various stages of drug development, post-marketing safety surveillance, and real world will be presented. Additionally, designs and strategies on how to use historical and published information to generate evidence for pediatric trials will be discussed.

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

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