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