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Activity Number:
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355
- 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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Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #304281
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Title:
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Combining Tabular Data with Visual Display to Enhance Interpretation of Clinical Trial Data
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Author(s):
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Teresa Curto* and Ashish Aggarwal and Angelo Tinazzi
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Companies:
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Cytel and Cytel and Cytel
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Keywords:
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clinical trials;
statistical graphics;
longitudinal analyses
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Abstract:
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Clinical trials require the production of vast amount of tables, listings and figures for submission to regulatory agencies. Sometimes there is the need to drill down further into the data in order to determine whether there are subgroups that respond differently to the study drug. In a phase 3 pivotal trial with several study sites, there was a statistically significant positive treatment effect. The study team wanted to know if there were study site differences. This presentation will demonstrate how tabular and graphic data were used to identify one large study site whose treatment outcomes were shown to be driving overall results. Forest plots showing mixed model for repeated measures (MMRM) effect sizes enabled us to look at differences among sites by study visit. By-site spaghetti plots were used to look at outcomes by treatment group over time. This information was used to examine whether there were patient characteristics or site issues that contributed different outcomes for subjects at that study site.
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Authors who are presenting talks have a * after their name.
