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Activity Number:
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307
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303827 |
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Title:
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Missing Data Handling in Medical Device Clinical Trials
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Author(s):
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Xu Yan*+ and Shiowjen Lee and Heng Li and Ning Li
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Companies:
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FDA and FDA and FDA and FDA
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Address:
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1350 Piccard Drive, HFZ-550, Rockville, MD, 20850,
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Keywords:
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clinical trial ; missing data ; tipping point analysis ; imputation method
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Abstract:
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The impact of missing data has always been a major concern in the interpretation clinical trial results. Procedures of statistical inference for handling missing data, such as multiple imputation, typically require the specification of missing data mechanism for their implementation. Therefore, when missing data mechanism is unknown, sensitivity analyses can usually provide helpful information. We will discuss several statistical methods that are commonly used to handle missing data in medical device clinical trials, focusing on tipping point analysis as a general approach for the assessment of missing data impact.
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