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Activity Number:
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467
- Alternative Data Sources Utilization in Clinical Development
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 10, 2022 : 2:00 PM to 3:50 PM
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Sponsor:
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Health Policy Statistics Section
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Abstract #322612
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Title:
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Bridging the Gap Between Clinical Trial and Real World Data: A Framework for Working with Real-World Data in Clinical Development
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Author(s):
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Laura L Fernandes*
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Companies:
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COTA Healthcare
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Keywords:
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real world data;
oncology;
electronic health records
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Abstract:
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This talk will cover some of the aspects to be considered when using real world data from electronic health records (EHR) in clinical research in oncology. The following aspects will be covered using examples and case studies a) key considerations when preparing data for regulatory submissions b) understanding the complexities of regulatory submissions augmented with RWD c) how to accurately capture progression and end points in RWD for regulatory submissions and d) key considerations for evaluating real-world data.
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Authors who are presenting talks have a * after their name.
