Addressing the Missing Data Problem in Clinical Trials

• Activity Number: 396
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Section on Survey Research Methods
• Author(s): Linda Yau*+
• Companies: Genentech
• Keywords: missing data mechanism ; sensitivity analysis ; clinical trials ; multiple imputation ; FDA ; repeated measures

Abstract

Missing data is not uncommon in clinical trials and is very often unavoidable. The presence of missing data often complicates the analysis of data. Methods have been proposed and developed to handle the analysis of clinical data with missing values; however, few of these methods are actually employed as the primary analysis in a clinical study for submission to the FDA. In this talk, current guidelines and strategies for addressing the missing data problem in various therapeutic areas will be reviewed and the difficulties encountered with using non-traditional analysis methodologies will be discussed. The role of sensitivity analyses and the use of multiple imputation as a sensitivity analysis tool will be discussed.