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Activity Number: 20 - Statistical Considerations for Using Historical Controls in Clinical Trials
Type: Topic Contributed
Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330833 Presentation
Title: Use of Real-World in Clinical Drug Development
Author(s): Xiuyu Julie Cong* and Susan Wang
Companies: Boehringer Ingelheim Pharmaceuticals Inc and Boehringer Ingelheim Pharmaceuticals Inc.
Keywords: Real-world data; Clinical drug development

In this talk, we will discuss the benefits and concerns of using real-world data in the drug development phase prior to regulatory approval and market launch. The main focus is on how to leverage real-world data to generate more relevant hypotheses in designing clinical trials, including clinically plausible treatment effect size, target patient population selection, feasibility assessment etc. We propose a Bayesian framework to incorporate real-world data. Simulation scenarios and case studies in immunology and oncology will be presented.

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

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