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Activity Number:
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77
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312187
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Title:
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ATCV: A Shiny Application for Safety Tables Review
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Author(s):
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Lie Li* and Yiwen Luo and Clare Bai
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
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Keywords:
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Shiny;
Safety Review;
Visualization
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Abstract:
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Regulatory submissions require a large number of safety tables for Clinical Study Report and Integrated Summaries of Safety. Some huge safety tables could include hundreds or even thousands of adverse events. Reviewers often have to validate and compare numbers from these safety tables manually. This traditional conventional review process is time-consuming and error-prone. We proposed an innovative R Shiny app, Auto Table Comparison and Visualization (ATCV), to alleviate the burdens during safety tables review process. Based on the interactive and intuitive Shiny app interface, users can easily use our tool with no prior experience. ATCV is aimed at automating comparison of tables and enabling visualization of safety review. ATCV helps users to get a comprehensive acknowledgment of all tables in one or more submitted packages rapidly. Furthermore, ATCV provides interactive visualization plots including heat maps, enhanced volcano and adverse event dot plots for safety review among two or more populations. Overall, ATCV is a compressive and user-friendly tool to guarantee high-quality submissions and enhance review efficiency.
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Authors who are presenting talks have a * after their name.
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