Missing Data Imputation Under Intention-to-Treat

• Activity Number: 170
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Steven Snapinn*+
• Companies: Amgen
• Keywords: Clinical Trials ; Missing Data ; Intention-to-treat ; Imputation

Abstract

The statistical and medical literature is nearly unanimous in the recommendation to avoid or prevent missing data whenever possible, which seems to be synonymous with a recommendation to adhere to the intention-to-treat principle. Of course, perfect adherence to intention-to-treat is typically not possible, and nearly every clinical trial has some degree of missing data. There are various alternative approaches for imputing missing data, but it is not clear how compatible these approaches are with intention-to-treat. In this presentation, I'll discuss the concept of missing data imputation for clinical trials intended to be conducted and analyzed under intention-to-treat, and provide recommendations.