Abstract Details
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Activity Number:
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63
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 3, 2014 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311849
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View Presentation
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Title:
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Missing Data in Safety Evaluation: Experiences and Case Examples
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Author(s):
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Aloka Chakravarty*+
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Companies:
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FDA
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Keywords:
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missing data ;
safety ;
observational studies
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Abstract:
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Missing data in safety evaluations can arise for various reasons. It can be due to secondary use of a clinical trial (or a set of clinical trials) not primarily designed for that safety endpoint in mind. It can even be in a situation where the drug (or a drug class) under investigation was only used as a concomitant medication in the clinical trials being examined. In both situations, the issue of structural missingness is encountered. Some regulatory experiences on these issues will be discussed, along with case examples. In addition, some lessons learnt on best practices going forward will be shared. (101 words)
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Authors who are presenting talks have a * after their name.
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