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Activity Number:
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548
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #320478
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View Presentation
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Title:
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Best Practices for Reporting Adverse Event Data to Data-Monitoring Committees
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Author(s):
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Hengrui Sun* and Kwanhye Jung and Sonia Davis
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Companies:
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The University of North Carolina at Chapel Hill and The University of North Carolina at Chapel Hill and The University of North Carolina at Chapel Hill
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Keywords:
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Data monitoring committee ;
Graphical display ;
Patient drop-out ;
Incidence density
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Abstract:
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Data Monitoring Committees (DMC) are charged with evaluation of patient safety in ongoing clinical trials. Periodic review involves scrutinizing rates of hundreds of adverse event (AE) coded terms. Data reports that accurately and clearly display trends are essential for identifying potential safety concerns. Both reviewability and statistical rigor are crucial, yet the most common reporting formats, such as tables of incidence rates and listings of individual events, lack both. Reviewability is substantially improved by graphical displays. Incidence densities can be superior to incidence rates by accounting for differential patient drop-out which can be caused by discontinuation due to adverse event in the active treatment group or lack of efficacy in placebo. Simulated examples depict the impact of differential discontinuation on incidence rates. We present graphical displays of AE rates and individual AE event profiles producible in SAS. These methods have been enthusiastically adopted by a current DMC.
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Authors who are presenting talks have a * after their name.
