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Abstract Details
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Activity Number:
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19
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302157 |
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Title:
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Assuring Device Trial Data Quality for Regulatory Decisionmaking: Can Data Standards Help?
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Author(s):
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Jianxiong Chu*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, 20993, USA
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Keywords:
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clinical trials ;
Data quality ;
Data standard
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Abstract:
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To make regulatory decision for new or novel medical devices, FDA usually needs to rely on clinical trial data to assess whether the trial results provide a reasonable assurance for device safety and effectiveness. Therefore, both FDA and the device industry share the same interest to ensure that the trial data is of high quality. In this talk, different definitions of data quality from multiple regulatory statistical reviewer perspectives will be discussed. In addition, common types of data error identified from the sponsor's submissions, their implications for statistical analyses and some potential benefits to adopt common data standard such as CDISC in relation to FDA-wide Janus project will also be discussed.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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