JSM 2005 - Toronto

Abstract #303926

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 323
Type: Contributed
Date/Time: Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303926
Title: Missing Data in Safety Evaluation: Analyses and Issues
Author(s): Satish Misra*+
Companies: U.S. Food and Drug Administration
Address: 1451 Rockville Pike, Rockville, MD, 20852, United States
Keywords: Efficacy ; Safety ; Missing ; Evaluation
Abstract:

The impact and assessment of the missing data in evaluating the efficacy of a new drug has been widely discussed. This paper focuses on understanding the impact and assessment of the missing data in evaluating the safety of a new drug/therapeutics, especially when the collection of safety data is prespecified in the protocol (e.g., evaluation of hematological toxicity every week for the first 13 weeks). The paper will focus on statistical analyses and issues related to impact of missing data in evaluating the safety of a new drug/therapeutics and practical examples will be discussed.

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Revised March 2005