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Mitigating Missing Data in Clinical Trials: Moving Toward Global Behavioral Change Impacts Efficacy, Safety, and Quality
Session Chair(s)
Carol Robertson-Plouch
Clinical Research Advisor
Eli Lilly and Company, United States
Missing data concerns have been illustrated recently by emerging safety and efficacy concerns with approved and unapproved medication. The bar is being raised regarding acceptability of clinical data with large amounts of missing data. What is this about? What mitigation strategies can be taken? This session will broaden your understanding of what missing data is, where it comes from, and the historical events leading to current scrutiny.
Learning Objective : Describe the two main types of missing data; Describe the impact that missing data can have on data integrity, statistical analyses, and conclusions from clinical data; Explain scientific and regulatory concerns and historic events; Discuss the positive impact that mitigation can have on missingness, data integrity, and even regulatory approvability.
Speaker(s)
Pharmaceutical Company Sponsor Perspective
Carol Robertson-Plouch
Eli Lilly and Company, United States
Clinical Research Advisor
Two and a Half Missing Data Problems
Lisa LaVange, PhD
University of North Carolina at Chapel Hill, United States
Professor Emerita
A Statistician's Perspective
Joshua Betcher
QuintilesIMS, United States
Sr. Director, Biostatistics
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