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Activity Number: 530
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #320922 View Presentation
Title: Using External Patient Data in Clinical Trial Simulation
Author(s): Forrest Williamson*
Companies: Eli Lilly and Company
Keywords: clinical trials ; simulation ; external patient data
Abstract:

This talk focuses on the use of patient-level data in trial simulation. Patient-level data may be used during simulation in multiple ways, such as building prior distributions, informing patient response models, or be directly resampled as virtual patients in the planned trial. Historically, the primary source of patient-level data was limited to internally conducted trials. These trials may to be more similar to the planned trial, but represent only a small portion of all relevant trials that have been conducted. As a greater number of externally run trials make their patient-level data available, it is important to consider how to integrate these sources of information. Incorporating external patient-level data adds heterogeneity, complexity, but can enhance our ability to estimate between-study variability. This talk will provide examples of using this information to design trials that are robust to a broader range of uncertainty.


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