Mitigating Missing Data: A Proactive Approach for Minimizing Occurrence in Clinical Trials

• Activity Number: 319
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Carol Robertson-Plouch*+ and Sarah Witt and Tina Oakes
• Companies: Eli Lilly and Company and Eli Lilly and Company and Eli Lilly and Company
• Keywords: missing data ; mitigating missing data ; prevention of missing data

Abstract

Concerns about missing data have drawn increased attention, illustrated by emerging safety and efficacy concerns with approved and unapproved medications. Regulatory scrutiny has increased based on questions about the rigor of scientific conclusions in the face of a large amount of missing data. In 2010, the EMA produced a guidance document regarding missing data. The same year, FDA initiated a project with the National Research Council, resulting in a lengthy white paper entitled "Prevention and Treatment of Missing Data in Clinical Trials." Statistical methods can and should be employed to appropriately address missing data. However, missing data occurs for a number of reasons. Identifying potential sources of missing data and evaluating mitigation strategies and tactics can help minimize the amount that occurs during clinical studies. This session will broaden participant's understanding why missing data occurs in clinical trials, and what steps can be taken to move toward improved mitigation of missing data.